ISRCTN15677760RecruitingNot Applicable
An investigation of the therapeutic impact of intra-carotid arterial transfusion of autologous peripheral blood-derived stem cell/progenitor cell (CD34+) therapy on acute ischemic stroke --- a phase II randomized controlled clinical trial
Chang Gung Memorial Hospital0 sites116 target enrollmentStarted: April 23, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 116
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Suffer from acute ischemic stroke within 14 ± 7 days
- •2. Evidence of brain ischemia on nuclear medicine examination
- •3. NIHSS score between 8 and 21
- •4. Already on standard medical therapy based upon stroke guideline, e.g., antiplatelet, antihypertensive, and statin.
Exclusion Criteria
- •1. Age less than 45 years old or more than 80 years old
- •2. Patients received t-PA and anticoagulation
- •3. Non-middle cerebral artery territory stroke or hemorrhagic stroke
- •4. Pregnant women
- •5. Patients with active infectious disease or autoimmune disorder
- •6. Myocardial infarction (MI) within 3 months
- •7. Severe aortic stenosis or mitral stenosis
- •8. Congestive heart failure, New York Heart Association functional class IV
- •9. Malignancy or other severe disease with life span less than one year
- •10. Chronic kidney disease with CCr<20ml/min and end stage renal disease
- •11. Join other clinical trials
- •12. Patients cannot receive regular follow-up
- •13. Other brain disease (tumor, degenerative disease, infective disease)
Investigators
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