Effect of Mesenchymal Stem Cells(MSCs) Transplantation for Acute Cerebral Infarction Patients (NCT04093336) | Clinical Trial Compass
UnknownPhase 1/2
Effect of Mesenchymal Stem Cells(MSCs) Transplantation for Acute Cerebral Infarction Patients
China120 participantsStarted 2019-01-13
Plain-language 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. Potential subjects must be screened and consented before enrolled.
The primary objective of this study is to determine the effects of early intravenous infusion of allogeneic human umbilical cord mesenchymal stem cells (HucMSCs or MSCs used in the following section) for patients with acute ischemic stroke. Eligible patients will receive a single dose of MSCs or placebo within 24 hours after stroke. Patients will be followed for 2 years post infusion for safety and efficacy (change in neurological symptoms and quality of life). Assessments will occur during transplantation and at 3,7, 14 days and1,3, 6, 12, 18 and 24 months after infusions of stem cells.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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