The therapeutic effect of autologous peripheral blood-derived stem cell therapy on acute brain infarcts

Recruiting

• Conditions: Patients with acute ischemic stroke and stationary condition in the convalescent phase; Circulatory System; Acute ischemic stroke

• Registration Number: ISRCTN15677760
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-23
• Last Update Posted: 28 May 2018
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 116

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Events of all-cause mortality and recurrent ischemic stroke are recorded at 90 days and 1 year

Secondary Outcome Measures

Name	Time	Method
1. Post-therapy 90-day combined endpoint of recurrent stroke or death<br>2. Post-therapy disability is evaluated with modified Rankin Scale score and Barthel Index; WAIS-III and CASI National Institutes of Health Stroke Scale (NIHSS) within 1, 3, and 30 days (±14 days) and 90 days (±14 days):<br>3. Post-therapy brain reperfusion status is measured by using brain Magnetic resonance imaging [Arterial Spin Labeling (ASL) and Dynamic Contrast Enhancement] at 24-72 hours and 90 days (±14 days) <br>4. Post-therapy brain perfusion defect evaluation is measured using radionuclear medicine image [brain Tc-99m scan] 24-72 hours and 90 days (±14 days) <br>5. Any adverse events are recorded within 5 years post-therapy