Clinical Trial: Efficacy Study of CD34 Stem Cell in Chronic Stroke Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Study of Autologous Peripheral Blood CD34 Stem Cell Implantation in Chronic Stroke Patients

Brief Summary: 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 Summary: 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.
Sponsor: China Medical University Hospital

Current Primary Outcome: NIH-stroke scale (NIHSS) [ Time Frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • European stroke scale (ESS) [ Time Frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months ]
  • European stroke motor subscale (EMS) [ Time Frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months ]
  • Barthel index and Mini-Mental State Examination (MMSE) [ Time Frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months ]
  • Magnetic resonance imaging (MRI) and computed tomography (CT) scans [ Time Frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months ]


Original Secondary Outcome: Same as current

Information By: China Medical University Hospital

Dates:
Date Received: July 30, 2009
Date Started: June 2009
Date Completion:
Last Updated: April 20, 2011
Last Verified: April 2011