Efficacy Study of CD34 Stem Cell in Chronic Stroke Patients

Completed

Phase 2 Results N/A

Trial Description

The objective of the study is to determine the efficacy of brain transplants of CD34+ stem cells obtained from peripheral blood of patients in the treatment of chronic stroke patients.

Detailed Description

30 patients are divided into 2 groups, one treatment group and one control group.Treatment group will be implanted with peripheral blood stem cell and receive convention stroke therapy ,and control group only receive convention stroke therapy. We expect that transplantation of the peripheral blood CD34+ cells has the potential of significant benefit to neurological recovery. In a previous phase I clinical trial, we have shown that transplantation of CD34+ cells obtained from the peripheral blood of the chronic stroke patients was safe and beneficial for neurological recovery. We expect this trial can further prove the efficacy of this treatment method.

Conditions

Interventions

  • Intercerebral implantation of Autulogous Stem Cells Procedure
    Other Names: PBSC; CD34 Stem Cell
    Intervention Desc: 2-8 millions Stem cell per patients plus convention therapy
    ARM 1: Kind: Experimental
    Label: PBSC Treatment
    Description: Patients in PBSC treatment will receive brain implant of autologous peripheral blood stem cell(CD34+) plus convention stroke treatment that include rehabilitation and antiplatelet medication
  • Convention therapy Drug
    Other Names: convention therapy
    Intervention Desc: antiplatelet
    ARM 1: Kind: Experimental
    Label: Control
    Description: Control group receive conventional stroke treatment that include rehabilitation and antiplatelet medication

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary NIH-stroke scale (NIHSS) 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months Yes
Secondary European stroke scale (ESS) 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months Yes
Secondary European stroke motor subscale (EMS) 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months Yes
Secondary Barthel index and Mini-Mental State Examination (MMSE) 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months Yes
Secondary Magnetic resonance imaging (MRI) and computed tomography (CT) scans 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months Yes

Sponsors