- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01673932
Safety and Feasibility Study of Umbilical Cord Blood Mononuclear Cells Transplant to Treat Ischemic Stroke
Phase 1 Clinical Trial to Establish the Safety and Feasibility of Transplants of Umbilical Cord Blood Mononuclear Cells in Chronic Ischemic Stroke
연구 개요
상세 설명
This is an open-label, delayed-treatment trial.
A total of 12 subjects fulfill the inclusion and exclusion criteria will be recruited and randomly assigned into two treatment group. Group A (early-treatment group) will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0. Group B (delayed-treatment group) will participate in 6 months observation before the UCBMC transplantation at Month 6. All subjects will be followed up for 18 months from enrollment at Day 0. Long-term follow-up will be carried up to 36 months if applicable.
The adverse events and safety parameters will be collected and recorded. In addition, the stroke scores , gait and brain MRI will be obtained before and after the treatment to assess the safety and potential treatment effect of UCBMC in chronic ischemic stroke.
연구 유형
등록 (예상)
단계
- 1단계
연락처 및 위치
연구 장소
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-
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Hong Kong, 홍콩
- 모병
- Queen Mary Hospital
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연락하다:
- Karrie Kiang
- 전화번호: +852 2255 4468
- 이메일: mykiang@hku.hk
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수석 연구원:
- Gilberto Ka Kit Leung, MD
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Shatin, 홍콩
- 모병
- Prince of Wales Hospital
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연락하다:
- Waisang Poon, MD
- 전화번호: +852 2632 1625
- 이메일: stroke-study@surgery.cuhk.edu.hk
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수석 연구원:
- Waisang Poon, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- either gender, age 35 -65 years old;
- ischemic stroke > 6 months and < 60 months;
- stable hemiplegia or hemiparesis condition > 3 months;
- stroke-induced clinical deficits affecting motor, perceptual, or language functions, with NIHSS of 5-15;
- stroke in the middle cerebral artery territory;
- subjects able to understand, sign and date the informed consent form
Exclusion Criteria:
- non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage;
- pregnant or lactating women;
- alcohol or drug abuse in previous 3 months;
- significant medical diseases or infections;
- current participation in another investigational study or taking any investigational drug within last 4 weeks before the screening;
- unavailability of HLA-matched umbilical cord blood unit;
- investigator suggests that the subject would not suitable to perform the surgery or participate in the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Group A - UCBMC Early Treatment Group
Group A subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0.
|
Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site
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실험적: Group B - UCBMC Delayed Treatment Group
Group B subject will partipate in 6 months observation and then receive the UCBMC transplant at month 6.
|
Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
National Institutes of Health Stroke Scale
기간: 18 months, up to 36 months
|
The change from the baseline in National Institutes of Health Stroke Scales
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18 months, up to 36 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
European Stroke Scale (ESS)
기간: 18 months, up to 36 months if applicable
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The change from baseline in ESS
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18 months, up to 36 months if applicable
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Barthel Index
기간: 18 months
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18 months
|
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Min-Mental State Examination (MMSE)
기간: 18 months
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The change from baseline in MMSE
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18 months
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MRI
기간: 18 months
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The change in MRI between pre-treatment and post-treatment
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18 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Safety as assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations.
기간: 18 months, up to 36 months follow-up
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Safety are assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations.
|
18 months, up to 36 months follow-up
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Waisang Poon, MD, The Chinese University of Hong Kong, Prince of Wales Hospital
- 수석 연구원: Gilberto Ka Kit Leung, MD, The University of Hong Kong, Queen Mary Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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. .
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