Study the Safety and Efficacy of Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Acute Cerebral Infarction
Overview
- Phase
- Phase 1
- Intervention
- Aspirin Tablet
- Conditions
- Cerebral Infarction
- Sponsor
- Sclnow Biotechnology Co., Ltd.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Treatment related-adverse events counting
- Status
- Suspended
- Last Updated
- 11 months ago
Overview
Brief Summary
The purposes of the study is to determine the safety and efficacy of treating acute ischemic stroke patients with human umbilical cord mesenchymal stem cells (hUC-MSC).
Detailed Description
This is a randomized, double-blind, paralleled study. 40 patients will be separated into two groups, and receive basic treatment (Aspirin Tablet). Patients in experimental group will receive hUC-MSC once a month, total 3 times. After the treatment, investigator will have follow-up visit for 6 months, evaluate the security and efficacy of hUC-MSC.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient within 2 weeks onset of symptoms.
- •Symptoms and signs of clinically definite acute cerebral infarction patients.
- •CT/MRI prove the Oxfordshire Community Stroke Project (OCSP) as Total Anterior circulation infarct (TACI), Partial Anterior circulation infarct (PACI), Posterior Anterior circulation infarct (POCI), or obvious neurological deficit lacunar infarction patient.
- •Signed informed consent after understanding all possible benefits and harm.
Exclusion Criteria
- •allergic to basic drug
- •with progressive stroke, transient ischemia attach, cerebral infarction with posterior cerebral hemorrhage, and cerebral arteritis.
- •tumor, injury, and parasites caused cerebral embolism
- •rheumatic heart disease, coronary heart disease, and other atrial fibrillation combined heart disease caused cerebral embolism
- •subject is processing thrombolytic therapy
- •subject is pregnancy and of childbearing potential or breast feeding
- •participate in any other clinical trial in last 3 months
- •bleeding tendency patient; severe bleeding tendency in last 3 month
- •with gastric duodenal ulcer
- •participants with severe liver and kidney, hematopoietic, and metabolic diseases; Or with liver and kidney function examination abnormal
Arms & Interventions
Group 1
Aspirin Tablet, 100mg/d; Allogeneic umbilical cord mesenchymal stem cells, 0.5-1\*10\^6/kg
Intervention: Aspirin Tablet
Group 1
Aspirin Tablet, 100mg/d; Allogeneic umbilical cord mesenchymal stem cells, 0.5-1\*10\^6/kg
Intervention: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)
Group 2
Aspirin Tablet, 100mg/d; Placebo
Intervention: Aspirin Tablet
Outcomes
Primary Outcomes
Treatment related-adverse events counting
Time Frame: 26 weeks
patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells
Secondary Outcomes
- NIH stroke scale (NIHSS)(26 weeks)
- Modified Rankin Scale(26 weeks)
- Barthel activities of daily living (ADL) Index(26 weeks)