Status:
UNKNOWN
Effect of Mesenchymal Stem Cells(MSCs) Transplantation for Acute Cerebral Infarction Patients
Lead Sponsor:
Shanghai East Hospital
Conditions:
Infarction, Middle Cerebral Artery
Infarction, Anterior Cerebral Artery
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a placebo controlled, randomized, double blinded study including Phase 1 and Phase 2. Phase I study is a safety assessment and Phase 2 study is incline to assess effectiveness of MSCs. Potenti...
Detailed Description
In Phase 1 study, the eligible patients of acute cerebral infarction within 7 days after onset will be randomized to MSCs group or control group and receive intravenous MSCs 2 x 10\^6/kg or placebo as...
Eligibility Criteria
Inclusion
- Acute ischemic stroke;
- Age 18\~80y;
- 4≤NIHSS score≤18（including limb score≥2）and modified Rankin scale 0-1 before this cerebral ischemic stroke;
- patients and their families understand and will cooperate within the whole process of study, and sign informed consent;
- any of following items：①acute cerebral infarction confirmed by cerebral CT perfusion or non-contrast computed tomographic scan \< 7 days after onset or ②acute cerebral infarction confirmed by cerebral MR image \< 7 days after onset
Exclusion
- accompanied by hematological disease, severe infection, liver dysfunction (ALT\>3\*ULN), kidney dysfunction (Scr \>2\*ULN), cardiac dysfunction (NYHA grade III or IV);
- Disturbance of consciousness, mental illness, cognitive impairment and other diseases that may affect informed consent and evaluation of study.
- Malignancy history or found to associate cancer after this stroke
- Pregnant or lactating women, or women have fertility requirements within 2 years;
- Accompanied by immunodeficiency diseases or autoimmune diseases;
- Life expectancy is less than 2 years;
- Participated in other clinical trial within 6 months;
- Patients received Chinese traditional medicine after onset of this stroke;
- Patients with allergic predisposition;
- Mental implantation or other reasons cannot tolerate magnetic resonance imaging;
- Cannot follow up regularly or unwilling to sign informed consent;
- Other situations not suitable for enrollment judged by the researchers;
Key Trial Info
Start Date :
January 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04093336
Start Date
January 13 2019
End Date
December 30 2024
Last Update
April 18 2023
Active Locations (1)
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1
Gang Li
Shanghai, Shanghai Municipality, China, 200123