The Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Acute Cerebral Infarction

Not yet recruiting

Phase 1 Results N/A

Trial Description

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.

Conditions

Interventions

  • Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) Biological
    Intervention Desc: Allogeneic umbilical cord mesenchymal stem cells will transfusion into by forearm intravenous transplantation, 0.5 - 1 *10^6/kg. once a month, total 3 times.
    ARM 1: Kind: Experimental
    Label: Group 1
    Description: Aspirin Tablet, 100mg/d; Allogeneic umbilical cord mesenchymal stem cells, 0.5-1*10^6/kg
  • Aspirin Tablet Drug
    Intervention Desc: Drug: Aspirin Tablet, 100 mg/d
    ARM 1: Kind: Experimental
    Label: Group 1
    Description: Aspirin Tablet, 100mg/d; Allogeneic umbilical cord mesenchymal stem cells, 0.5-1*10^6/kg
    ARM 2: Kind: Experimental
    Label: Group 2
    Description: Aspirin Tablet, 100mg/d; Placebo

Outcomes

Type Measure Time Frame Safety Issue
Primary Treatment related-adverse events counting 26 weeks
Secondary Modified Rankin Scale 26 weeks
Secondary Barthel activities of daily living (ADL) Index 26 weeks
Secondary NIH stroke scale (NIHSS) 26 weeks

Sponsors