동종 HB-adMSC를 이용한 파킨슨병 임상시험(초기 및 중등도 PD)
파킨슨병 환자 치료를 위한 동종 HB-adMSC 대 위약의 무작위, 이중 맹검, 단일 센터, 2상, 효능 및 안전성 연구
연구 개요
상세 설명
이번 임상시험은 최대 4주간의 스크리닝 기간, 32주간의 치료 기간, 최종 임상시험용 제품 투여 후 20주간의 안전성 추적 기간을 포함한다.
이 임상 시험은 파킨슨병 진단을 받은 적격 참가자 60명을 등록하기 위해 공개됩니다. 환자 모집은 연구 팀에 의해 수행되며, 적격성 기준에 따라 적격 참가자가 확인되면 스크리닝 방문 일정이 잡힙니다. 정보에 입각한 동의서가 연구 참여자에게 제공되고 연구 절차 전에 서명됩니다. 정보에 입각한 동의서에는 임상 시험에 대한 정보가 포함되며 이 과정에서 몇 가지 측면을 고려해야 합니다.
사전 동의를 얻은 후 각 참가자는 다음 방문을 완료해야 합니다.
- 방문 1 - 스크리닝, 이 방문 동안 주임 조사관은 스크리닝된 참가자가 자격이 있는지 여부와 다음 방문 일정을 잡을 수 있는지 여부를 결정합니다. 일단, 주 조사관이 스크리닝된 피험자의 적격성을 평가하면(최대 28일) 적격 피험자를 동종이계 HB-adMSC 또는 위약으로 할당하기 위해 무작위화 프로세스가 수행됩니다. 무작위화는 적격 대상자에게만 적용됩니다. 연구 참가자가 스크리닝 과정에서 포함 및 제외 기준을 충족하지 않는 경우, 그/그녀는 스크리닝 실패(SF)로 간주되며 무작위 배정이 필요하지 않습니다.
- 방문 2 - 주입 1, (기준선): 이 방문은 참가자의 데이터 비교를 위한 시작점으로 사용됩니다. 이 방문 동안 적격 연구 참가자는 약물 노출 후 총 2시간 동안 활력 징후 모니터링과 함께 첫 번째 조사 제품 투여 또는 위약을 받게 됩니다. 다른 연구 평가는 이번 방문의 일부로 완료될 것입니다.
- 방문 3 - 주입 2: 초기 연구 제품 투여 후 약 4주 후에 이 방문을 완료해야 합니다. 다른 연구 평가는 이번 방문의 일부로 완료될 것입니다.
- 방문 4 - 주입 3: 초기 조사 제품 투여 후 약 8주 후에 이 방문을 완료해야 합니다. 다른 연구 평가는 이번 방문의 일부로 완료될 것입니다.
- 방문 5 - 주입 4: 초기 연구 제품 투여 후 약 12주에 이 방문을 완료해야 합니다. 다른 연구 평가는 이번 방문의 일부로 완료될 것입니다.
- 방문 6 - 주입 5: 초기 조사 제품 투여 후 약 16주에 이 방문을 완료해야 합니다. 다른 연구 평가는 이번 방문의 일부로 완료될 것입니다.
- 방문 7 - 주입 6: 초기 연구 제품 투여 후 약 20주에 이 방문을 완료해야 합니다. 다른 연구 평가는 이번 방문의 일부로 완료될 것입니다.
- 전화 통화 - 안전성 후속 조치: 초기 연구 제품 투여 후 약 24주 후에 활성 연구 참가자가 전화 통화 후속 조치를 완료합니다.
- 전화 통화 - 안전성 후속 조치: 초기 연구 제품 투여 후 약 32주 후에 활성 연구 참가자가 전화 통화 후속 조치를 완료합니다.
- 방문 8 - 연구 종료, 이 최종 방문 동안(0주 후 약 52주) 연구 평가의 전체 그룹이 동종이계 HB-adMSC 또는 위약 투여의 안전성 및 효능을 평가하기 위해 수행될 것입니다.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Texas
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Sugar Land, Texas, 미국, 77478
- Hope Biosciences Stem Cell Research Foundation
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
연구 참가자는 다음 기준이 모두 적용되는 경우에만 이 연구에 포함될 수 있습니다.
- 45~80세의 남녀 참가자.
- 스크리닝 방문에서 연구 참여자는 7~28점 사이의 MDS-UPDRS 파트 II 점수를 가져야 합니다.
- 연구 참가자는 스크리닝 방문 동안 20에서 57 사이의 MDS-UPDRS 파트 III 점수를 가져야 합니다.
- Carbidopa/Levodopa 총 용량은 연구 참가자의 경우 하루 1200mg 미만이어야 합니다.
- 연구 참가자의 총 레보도파 등가 용량은 하루 1400mg 미만이어야 합니다.
- 연구 참여자는 연구 참여 최소 2년 전에 조기 및/또는 중등도 파킨슨병 진단을 받았어야 합니다.
- 연구 참여자는 읽고 이해하고 서면 동의를 제공할 수 있어야 합니다.
- 임상 시험 관련 절차를 수행하기 전에 자발적으로 서명한 정보에 입각한 동의서.
- 여성 연구 참가자는 연구 참여 기간 및 마지막 연구 제품 투여 후 6개월 동안 임신하지 않았거나 임신할 계획이 없어야 합니다.
- 성 파트너가 임신할 수 있는 남성 참가자는 연구 참여 기간과 조사 제품의 마지막 투여 후 6개월 동안 피임 방법을 사용해야 합니다.
- 연구 참가자는 이 임상 시험의 요구 사항을 준수할 수 있고 준수할 의향이 있습니다.
제외 기준:
연구 참가자는 다음 기준 중 하나라도 적용되는 경우 이 임상 시험에 포함될 자격이 없습니다.
- 임신, 수유. 임신하지 않았지만 효과적인 피임 조치를 취하지 않는 가임기 여성.
- 중증 장애, 휠체어에 묶인 상태 또는 침대에 누워 있는 상태로 설명된 진행성 파킨슨병을 가진 연구 참가자.
- 연구 참가자는 피부 기저, 편평 세포 암종 또는 흑색종의 증거를 포함하여 활동성 악성 종양이 있습니다.
- 연구 참가자는 알코올 중독 또는 의존성을 알고 있거나 현재 약물 사용 또는 남용이 있습니다.
연구 참가자는 다음을 포함하여 1개 이상의 중요한 동시 의학적 상태(의료 기록으로 확인됨)를 가지고 있습니다.
- 제대로 조절되지 않는 진성 당뇨병(PCDM)은 치료 기준 치료의 부족 및/또는 스크리닝 방문 동안의 식전 포도당 >130mg/dl 또는 식후 포도당 >200mg/dl의 이력으로 정의됩니다.
- 만성 신장 질환(CKD) 진단 병력 및/또는 eGFR < 59mL/min/1.73m2의 스크리닝 결과.
- 스크리닝 방문 중 뉴욕 심장 협회(NYHA) 클래스 III/IV 심부전의 존재.
- ST 상승 심근 경색(STEMI) 또는 비 ST 상승 심근 경색(NSTEMI), 관상 동맥 연축 또는 불안정 협심증과 같은 다양한 유형의 심근 경색 병력.
- 관리 치료 기준 부족 및/또는 스크리닝 방문 중 혈압 > 180/120 mm/Hg로 정의되는 조절되지 않는 고혈압의 병력.
- 유전성 혈전성향증 병력, 최근 대수술(검진 전 12개월 이내), 척수 손상으로 인한 하지 마비, 골반, 고관절 또는 대퇴골 골절, 폐암, 뇌암, 림프암, 부인과암( 난소 또는 자궁) 또는 위장관(예: 췌장 또는 위).
- 파킨슨병에 대한 뇌 수술의 역사.
- 연구 참가자는 희망 바이오사이언스에서 생산한 줄기 세포 이외의 첫 번째 연구 제품 투여 전 6개월 이내에 줄기 세포 치료를 받았습니다.
- COVID-19 백신 이외의 시험용 제품의 첫 투여 전 1년 이내에 시험용 요법 또는 시험용으로 승인된 요법을 받은 경우.
연구 참여자는 스크리닝 중에 다음을 포함하는 검사실 이상이 있습니다.
- 백혈구 수 < 3000/mm3
- 혈소판 수 < 80,000mm3
- 절대 호중구 수 < 1500/mm3
- ALT(Alanine aminotransferase) 또는 AST(aspartate aminotransferase) 10 정상 상한(ULN) x 1.5
- 연구 참가자는 연구자의 의견에 따라 안전 위험을 제기하거나 피험자가 연구를 완료하는 데 방해가 되는 다른 실험실 이상 또는 의학적 상태를 가지고 있습니다.
- 연구 참가자는 연구를 완료하거나 연구 절차를 준수할 가능성이 없습니다.
- 동시 급성 또는 만성 바이러스성 B형 간염 또는 C형 간염 또는 인간 면역결핍 바이러스(HIV) 감염이 알려진 연구 참여자.
- 연구 참가자는 조사관의 의견에 따라 자기 평가에 영향을 미칠 수 있는 이전에 진단된 정신 질환을 가지고 있습니다.
- 연구 제품의 첫 투여 전 30일 이내에 항생제, 항바이러스제 또는 항진균제로 치료가 필요한 전신 감염이 있는 연구 참여자.
- 연구 기간 동안 또는 마지막 투여 후 6개월 이내에 정자를 기증할 계획인 남성 연구 참여자. 연구 기간 동안 또는 마지막 투여 후 6개월 이내에 난자를 기증하거나 체외 수정 치료를 받을 계획인 여성 환자.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: 동종 HB-adMSC.
생물학적/백신: 동종 HB-adMSC 동종 HB-adMSC는 자격이 있는 연구 참여자에게 정맥 주사로 투여됩니다. 다른 이름: Allogeneic Hope Biosciences 지방 유래 간엽 줄기 세포. |
HB-adMSC는 자격이 있는 참가자에게 정맥 주사로 투여됩니다.
다른 이름들:
멸균 식염수 0.9%
다른 이름들:
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위약 비교기: 위약
위약은 적격한 연구 참여자에게 정맥 주사로 투여됩니다. 다른 이름: 멸균 식염수 0.9% |
HB-adMSC는 자격이 있는 참가자에게 정맥 주사로 투여됩니다.
다른 이름들:
멸균 식염수 0.9%
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in MDS-UPDRS Part III Total Score
기간: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part III.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total).
Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe.
The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability).
Higher values represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in MDS-UPDRS Part III (Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part III.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total).
Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe.
The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability).
Higher values represent a worse outcome.
|
Baseline to Weeks 52
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Change From Baseline in MDS-UPDRS Part III (Bayesian Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part III.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total).
Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe.
The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability).
Higher values represent a worse outcome.
|
Baseline to Weeks 52
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Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part III Score - by Treatment Week
기간: Baseline to Weeks 52
|
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total).
Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe.
The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability).
Higher values represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in MDS-UPDRS Part II Total Score
기간: Baseline to Weeks 52
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Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
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Changes From Baseline in MDS-UPDRS Part II (Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
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Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
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Change From Baseline in MDS-UPDRS Part II (Bayesian Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part II Score - by Treatment Week
기간: Baseline to Weeks 52
|
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients.
The MDS-UPDRS scale consists of 4 segments.
Part II tests "Motor Aspects of Experiences of Daily Living".
Each answer to the scale is evaluated by the principal investigator during the study visit.
Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity.
There are 13 items included in Part II.
Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe.
Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part I Total Score
기간: Baseline to Weeks 52
|
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part I (Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part I (Bayesian Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part I Score - by Treatment Week
기간: Baseline to Weeks 52
|
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome. |
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score
기간: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part IV.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part IV tests "Motor Complications", including time spent with dyskinesias and others.
There are 6 items included in Part IV.
Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe.
Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score (Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part IV.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part IV tests "Motor Complications", including time spent with dyskinesias and others.
There are 6 items included in Part IV.
Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe.
Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score (Bayesian Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
Clinically significant changes in MDS-UPDRS Part IV.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part IV tests "Motor Complications", including time spent with dyskinesias and others.
There are 6 items included in Part IV.
Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe.
Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part IV Score - by Treatment Week
기간: Baseline to Weeks 52
|
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients.
Part IV tests "Motor Complications", including time spent with dyskinesias and others.
There are 6 items included in Part IV.
Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe.
Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe).
The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability.
Higher values represent a worse outcome.
|
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average General Health) Total Score
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health) Total Score
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average General Health) Total Score (Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score (Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health ) Total Score (Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score (Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average General Health) Total Score (Bayesian Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Bayesian Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Bayesian Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Bayesian Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Role Limitations Due To Physical Health) Total Score (Bayesian Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in SF-36 (Average Role Limitations Due To Emotional Problems) Total Score (Bayesian Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods. |
Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Raw Scores
기간: Baseline to Weeks 52
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The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients.
It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function.
It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect.
There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points).
The PFS-16 score ranges from 16 (minimum) to 80 (maximum).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
Clinically significant changes in PFS-16 scores.
The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients.
It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function.
It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect.
There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points).
The PFS-16 score ranges from 16 (minimum) to 80 (maximum).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Bayesian Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
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Clinically significant changes in PFS-16 scores.
The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients.
It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function.
It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect.
There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points).
The PFS-16 score ranges from 16 (minimum) to 80 (maximum).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores
기간: Baseline to Weeks 52
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Clinically significant changes in PDQ-39 SI raw scores.
The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month.
The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being.
Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always).
The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100).
To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
Clinically significant changes in PDQ-39 SI raw scores.
The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month.
The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being.
Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always).
The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100).
To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100).
Higher scores represent a worse outcome.
|
Baseline to Weeks 52
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Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Bayesian Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
Clinically significant changes in PDQ-39 SI raw scores.
The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month.
The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being.
Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always).
The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100).
To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100).
Higher scores represent a worse outcome.
|
Baseline to Weeks 52
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Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores - by Treatment Week
기간: Baseline to Weeks 52
|
The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month.
The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being.
Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always).
The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100).
To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100).
Higher scores represent a worse outcome.
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Baseline to Weeks 52
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Change From Baseline in Visual Analog Scale (VAS) Pain Raw Scores
기간: Baseline to Weeks 52
|
Clinically significant changes in VAS Pain raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas.
The patient marks a point on the line corresponding to their pain intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
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Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
Clinically significant changes in VAS Pain raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas.
The patient marks a point on the line corresponding to their pain intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
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Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Bayesian Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
Clinically significant changes in VAS Pain raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas.
The patient marks a point on the line corresponding to their pain intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
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Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Raw Scores
기간: Baseline to Weeks 52
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Clinically significant changes in VAS Muscle Spasm raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas.
The patient marks a point on the line corresponding to their muscle spasm intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
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Baseline to Weeks 52
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Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
Clinically significant changes in VAS Muscle Spasm raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas.
The patient marks a point on the line corresponding to their muscle spasm intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
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Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Bayesian Statistical Analysis - RMA Model)
기간: Baseline to Weeks 52
|
Clinically significant changes in VAS Muscle Spasm raw scores.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas.
The patient marks a point on the line corresponding to their muscle spasm intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm.
Higher scores represent worse outcomes.
|
Baseline to Weeks 52
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Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total VAS Scores - by Treatment Week
기간: Baseline to Weeks 52
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The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" in the Pain section and "No muscle spasm" and "worst muscle spasm" in the Muscle Spasm section, used to measure intensity in pain and various other areas.
The patient marks a point on the line corresponding to their pain intensity.
The minimum score is read as 0 cm and the maximum score is read as 10 cm for each section.
The total score is achieved by summing the two individual scores.
Higher scores represent worse outcomes.
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Baseline to Weeks 52
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Summary of PD Medication Dose Changes by Visit
기간: Baseline to Weeks 52
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The following table depicts the count of participants that decreased, increased, or did not change their Parkinson's disease medication dosage over the course of the study at various timepoints.
The safety analysis set (30 patients in Placebo, 30 patients in HB-adMSCs) was assessed at the various timepoints.
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Baseline to Weeks 52
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Summary of PD Medication Reinstatement by Visit
기간: Baseline to Weeks 52
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The table prior to this one depicts the count of participants that decreased, increased, or did not change their Parkinson's disease medication dosage over the course of the study at various timepoints.
This table depicts the count of participants that reinstated their dose of Parkinson's disease medications after decreasing it throughout the clinical trial.
The safety analysis set (30 patients in Placebo, 30 patients in HB-adMSCs) was assessed at the various timepoints.
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Baseline to Weeks 52
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Treatment Emergent Adverse Events (Subjects With >= 1 Adverse Event) - Summary - Safety Analysis Set
기간: Baseline to Week 24
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Unit (# of participants) - Treatment emergent Adverse events (Subjects with >= 1 adverse event) - Summary - Safety analysis set.
Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1).
A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
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Baseline to Week 24
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Treatment Emergent Adverse Events (Serious AEs) - Summary - Safety Analysis Set
기간: Baseline to Week 24
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Unit (# of participants) - Treatment emergent Adverse events (Serious AEs) - Summary - Safety analysis set.
Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1).
A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
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Baseline to Week 24
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Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
기간: Baseline to Weeks 52
|
Unit (x10^9 cells/L) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
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Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
기간: Baseline to Weeks 52
|
Unit (%) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
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Change From Baseline Laboratory Values - CBC (g/dL) [Time Frame: Baseline to Week 52]
기간: Baseline to Weeks 52
|
Unit (g/dL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
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Change From Baseline Laboratory Values - CBC (pg) [Time Frame: Baseline to Week 52]
기간: Baseline to Weeks 52
|
Unit (pg) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
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Change From Baseline Laboratory Values - CBC (fL) [Time Frame: Baseline to Week 52]
기간: Baseline to Weeks 52
|
Unit (fL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
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|
Change From Baseline Laboratory Values - CBC (10^12/L) [Time Frame: Baseline to Week 52]
기간: Baseline to Weeks 52
|
Unit (10^12/L) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
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Change From Baseline Laboratory Values - CMP (g/dL) [Time Frame: Baseline to Week 52]
기간: Baseline to Weeks 52
|
Unit (g/dL) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
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Baseline to Weeks 52
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Change From Baseline Laboratory Values - CMP (Ratio) [Time Frame: Baseline to Week 52]
기간: Baseline to Weeks 52
|
Unit (Ratio) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
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|
Change From Baseline Laboratory Values - CMP (IU/L) [Time Frame: Baseline to Week 52]
기간: Baseline to Weeks 52
|
Unit (IU/L) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52]
기간: Baseline to Weeks 52
|
Unit (mg/dL) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CMP (mmol/L) [Time Frame: Baseline to Week 52]
기간: Baseline to Weeks 52
|
Unit (mmol/L) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - CMP (mL/Min/1.73 m^2) [Time Frame: Baseline to Week 52]
기간: Baseline to Weeks 52
|
Unit (mL/min/1.73
m^2) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - Coagulation Panel (Ratio) [Time Frame: Baseline to Week 52]
기간: Baseline to Weeks 52
|
Unit (Ratio) - Change From Baseline Clinical Laboratory Coagulation Panel by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline Laboratory Values - Coagulation Panel (Sec.) [Time Frame: Baseline to Week 52]
기간: Baseline to Weeks 52
|
Unit (sec.) - Change From Baseline Clinical Laboratory Coagulation Panel by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure - mmHg)
기간: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Heart Rate - Beats/Min)
기간: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Oxygen Saturation - %)
기간: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Respiration Rate - Breaths/Min)
기간: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure - mmHg)
기간: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Temperature - Celsius)
기간: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Change From Baseline in Vital Signs (Weight - kg)
기간: Baseline to Weeks 52
|
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Abdomen
기간: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
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|
Physical Examination - by Treatment Week - Cardiovascular
기간: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - HEENT
기간: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set - Head, Eyes, Ears, Nose, and Throat
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Lymph Node
기간: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Musculoskeletal
기간: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Neurological
기간: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Respiratory
기간: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
|
Physical Examination - by Treatment Week - Skin
기간: Baseline to Weeks 52
|
Physical examination - by treatment week - Summary - Safety analysis set
|
Baseline to Weeks 52
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Djamchid Lotfi, MD, Hope Biosciences Stem Cell Research Foundation
간행물 및 유용한 링크
일반 간행물
- Meirelles Lda S, Fontes AM, Covas DT, Caplan AI. Mechanisms involved in the therapeutic properties of mesenchymal stem cells. Cytokine Growth Factor Rev. 2009 Oct-Dec;20(5-6):419-27. doi: 10.1016/j.cytogfr.2009.10.002. Epub 2009 Nov 18.
- Garretti F, Agalliu D, Lindestam Arlehamn CS, Sette A, Sulzer D. Autoimmunity in Parkinson's Disease: The Role of alpha-Synuclein-Specific T Cells. Front Immunol. 2019 Feb 25;10:303. doi: 10.3389/fimmu.2019.00303. eCollection 2019.
- Musial-Wysocka A, Kot M, Majka M. The Pros and Cons of Mesenchymal Stem Cell-Based Therapies. Cell Transplant. 2019 Jul;28(7):801-812. doi: 10.1177/0963689719837897. Epub 2019 Apr 24.
- Giannini EG, Testa R, Savarino V. Liver enzyme alteration: a guide for clinicians. CMAJ. 2005 Feb 1;172(3):367-79. doi: 10.1503/cmaj.1040752.
- Kalia LV, Lang AE. Parkinson's disease. Lancet. 2015 Aug 29;386(9996):896-912. doi: 10.1016/S0140-6736(14)61393-3. Epub 2015 Apr 19.
- Dimarino AM, Caplan AI, Bonfield TL. Mesenchymal stem cells in tissue repair. Front Immunol. 2013 Sep 4;4:201. doi: 10.3389/fimmu.2013.00201.
- Cuenca L, Gil-Martinez AL, Cano-Fernandez L, Sanchez-Rodrigo C, Estrada C, Fernandez-Villalba E, Herrero MT. Parkinson's disease: a short story of 200 years. Histol Histopathol. 2019 Jun;34(6):573-591. doi: 10.14670/HH-18-073. Epub 2018 Dec 12.
- Goetz CG. The history of Parkinson's disease: early clinical descriptions and neurological therapies. Cold Spring Harb Perspect Med. 2011 Sep;1(1):a008862. doi: 10.1101/cshperspect.a008862.
- Stoker TB, Greenland JC, editors. Parkinson's Disease: Pathogenesis and Clinical Aspects [Internet]. Brisbane (AU): Codon Publications; 2018 Dec 21. Available from http://www.ncbi.nlm.nih.gov/books/NBK536721/
- Armstrong MJ, Okun MS. Diagnosis and Treatment of Parkinson Disease: A Review. JAMA. 2020 Feb 11;323(6):548-560. doi: 10.1001/jama.2019.22360.
- Tambasco N, Romoli M, Calabresi P. Levodopa in Parkinson's Disease: Current Status and Future Developments. Curr Neuropharmacol. 2018;16(8):1239-1252. doi: 10.2174/1570159X15666170510143821.
- Marsden CD. Problems with long-term levodopa therapy for Parkinson's disease. Clin Neuropharmacol. 1994;17 Suppl 2:S32-44.
- Coppin L, Sokal E, Stephenne X. Thrombogenic Risk Induced by Intravascular Mesenchymal Stem Cell Therapy: Current Status and Future Perspectives. Cells. 2019 Sep 27;8(10):1160. doi: 10.3390/cells8101160.
- Tatsumi K, Ohashi K, Matsubara Y, Kohori A, Ohno T, Kakidachi H, Horii A, Kanegae K, Utoh R, Iwata T, Okano T. Tissue factor triggers procoagulation in transplanted mesenchymal stem cells leading to thromboembolism. Biochem Biophys Res Commun. 2013 Feb 8;431(2):203-9. doi: 10.1016/j.bbrc.2012.12.134. Epub 2013 Jan 9.
- Tan EK, Chao YX, West A, Chan LL, Poewe W, Jankovic J. Parkinson disease and the immune system - associations, mechanisms and therapeutics. Nat Rev Neurol. 2020 Jun;16(6):303-318. doi: 10.1038/s41582-020-0344-4. Epub 2020 Apr 24.
- Ra JC, Shin IS, Kim SH, Kang SK, Kang BC, Lee HY, Kim YJ, Jo JY, Yoon EJ, Choi HJ, Kwon E. Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans. Stem Cells Dev. 2011 Aug;20(8):1297-308. doi: 10.1089/scd.2010.0466. Epub 2011 Mar 17.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .