Human Umbilical Cord Mesenchymal Stem Cell Therapy for Cerebral Infarction Patients in Convalescent Period.

Not yet recruiting

Phase 1/2 Results N/A

Trial Description

This is a randomized, double-blind study. Human umbilical cord mesenchymal stem cells (hUC-MSC) will be treated on cerebral infarction patients, and evaluates their neurological function of convalescent period.

Detailed Description

40 participants will be selected based on eligibility criteria and collected information, then, randomly separated into two groups. All participants will sign informed consent form, monitor vital signs, laboratory examination (CT/MRI, blood routine examination, urine routine examination, liver function, renal function, etc.), NIHSS, Fugl-Meyer analysis (FMA) 0-3 days before treatment. All of them will receive basic treatment with Aspirin Enteric-coated Tablets and Atorvastatin Calcium. And experimental group will treat with hUC-MSC, control group with placebo (normal saline) on the 7th and 14th day. After the treatment, investigator will follow-up, monitor vital signs, laboratory examination, NIHSS, FMA analysis on 2 weeks, 1 month, and 6 months after the treatment.

Conditions

Interventions

  • Allogeneic umbilical cord mesenchymal stem cell Biological
    Intervention Desc: Experimental group receive Allogeneic umbilical cord mesenchymal stem cell,i.v (SCLnow 19#)
    ARM 1: Kind: Experimental
    Label: Experimental group
    Description: Basic medication:Aspirin Enteric-coated Tablets & Atorvastatin Calcium; Allogeneic umbilical cord mesenchymal stem cells
  • Aspirin Enteric-coated Tablets & Atorvastatin Calcium Drug
    Intervention Desc: Aspirin Enteric-coated Tablets, 0.1g/d by mouth; Atorvastatin Calcium, 20mg/d by mouth.
    ARM 1: Kind: Experimental
    Label: Experimental group
    Description: Basic medication:Aspirin Enteric-coated Tablets & Atorvastatin Calcium; Allogeneic umbilical cord mesenchymal stem cells
    ARM 2: Kind: Experimental
    Label: Control group
    Description: Basic medication:Aspirin Enteric-coated Tablets & Atorvastatin Calcium; Placebo:saline

Outcomes

Type Measure Time Frame Safety Issue
Primary Motor function analysis 6 months
Secondary Neurological deficits analysis 6 months
Secondary Limb motor function analysis 6 months
Secondary Barthel Index analysis 6 months

Sponsors