- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03726814
A Clinical Study of iEPC Intervent Subjects With Cerebral Hemorrhagic Stroke
A Safety and Efficacy Study of Human Peripheral Blood Derived Induced EPCs for Cerebral Hemorrhagic Stroke
연구 개요
상세 설명
연구 유형
등록 (예상)
단계
- 초기 1단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Subjects ≥ 18 and ≤ 80 years of age
Subjects was confirmed cerebral hemorrhagic stroke, included at least one of risk factors(Hypertension, diabetes, coronary heart disease, high blood lipid), and Satisfied with one of the following conditions:
A. Significant stenosis (> 50%) of the intracranial and extracranial arteries or their branches due to atherosclerosis, or clinical or imaging manifestations of vascular blockage B. Head imaging (CT or MRI) : cerebral hemispheric infarct lesion diameter of > 1.5cm; Or there were more than 2 discontinuous lesions in the blood supply area of the same intracranial external artery.
C. Auxiliary examination: color ultrasonography, CTA, MRA or DSA of the blood vessels in the neck confirmed that the intracranial or extracranial stenosis was greater than or equal to 50%;
- Serum creatinine ≤ 1.5 mg/dl ; Serum ALT/AST)≤2.5×ULN;ALB≥25g/L;
- Serum creatinine≤ 176.8umol/L(2.0 mg/dl);
- Prothrombin time(PT)≤15s,International standardization rates(INR)<1.7;
- The glucose should be control between 2.8~22.2mmol/L(50~400mg/dl);
- Adult patients were willing to use reliable contraceptives (such as condoms) and not to donate sperm throughout the study period and within three months of discharge
- Subjects and the guardians able to undergo post-physical therapy/rehabilitation
Exclusion Criteria:
- Non-atherogenic cerebral infarction: cardiogenic embolization, small artery occlusion type IS, other exact etiology IS, and unknown etiology IS
- Combined with cerebral hemorrhage or previous intracranial external blood history, arteriovenous malformation and aneurysm history, or prone to hemorrhage (platelet count below 100 x 109/L)
- The vital signs of subjects are not stable
- Subjects with Class III/IV cardiovascular disability according to the New York Heart Association Classification
- At rest systolic pressure of 170mmHg or diastolic pressure of 105mmHg, or other indications of uncontrolled hypertension
- Subjects have one kinds of tumors within 5 years
- The subject was suffering from neurological or mental illness
- Subjects had congenital or acquired immune deficiencies, active tuberculosis and other active infections (e.g., pulmonary infection, urinary tract infection, skin infection)
- alcoholics
- Receipt of any investigational drug or device within 3 month
- Active hepatitis B (HBV DNA>1000copy/mL), hepatitis C or HIV infection
- Subjects who have other conditions that were not appropriate for the group determined by the researchers.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: EPC treatment group
|
Brain injection EPC
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Incidence of Treatment Emergent AE
기간: 1 year
|
Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
|
1 year
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
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. .
EPC treatment group에 대한 임상 시험
-
Allife Medical Science and Technology Co., Ltd.First Affiliated Hospital Xi'an Jiaotong University모병
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...모병
-
Exciton Technologies Inc.완전한당뇨성 족부궤양 | 당뇨병 발 감염 | 낫지 않는 당뇨병성 족부궤양캐나다
-
Allife Medical Science and Technology Co., Ltd.아직 모집하지 않음
-
Northern TherapeuticsOttawa Hospital Research Institute모집하지 않고 적극적으로
-
Aarhus University HospitalUniversity of Aarhus완전한