Phase II Study of Autologous Peripheral Blood CD34 Stem Cell Implantation in Chronic Stroke Patients
Overview
- Phase
- Phase 2
- Intervention
- Intercerebral implantation of Autulogous Stem Cells
- Conditions
- Stroke
- Sponsor
- China Medical University Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- NIH-stroke scale (NIHSS)
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •aged 35-70 chronic stroke adult patient,
- •with stroke history of more than 6 months, less than 60 months，
- •with stable hemiplegia condition, and
- •NIHSS (NIH Stroke Scale) score is between 9-20.
Exclusion Criteria
- •patients aged less than 35 or more than 70,
- •hemorrhage stroke or MRI show the occlusion is not in the middle cerebral artery territory，NIHSS is not in the range of 9-20,
- •pregnant women,
- •impaired liver function, abnormal blood coagulation, AIDS, combine other tumor or special condition.
Arms & Interventions
PBSC Treatment
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
Intervention: Intercerebral implantation of Autulogous Stem Cells
Control
Control group receive conventional stroke treatment that include rehabilitation and antiplatelet medication
Intervention: convention therapy
Outcomes
Primary Outcomes
NIH-stroke scale (NIHSS)
Time Frame: 1, 2, 4, 12 weeks, and confirmed at 6 and 12 months
Secondary Outcomes
- European stroke scale (ESS)(1, 2, 4, 12 weeks, and confirmed at 6 and 12 months)
- European stroke motor subscale (EMS)(1, 2, 4, 12 weeks, and confirmed at 6 and 12 months)
- Barthel index and Mini-Mental State Examination (MMSE)(1, 2, 4, 12 weeks, and confirmed at 6 and 12 months)
- Magnetic resonance imaging (MRI) and computed tomography (CT) scans(1, 2, 4, 12 weeks, and confirmed at 6 and 12 months)