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

• Register: ISRCTN
• Last refreshed on: 28 May 2018
• Main ID: ISRCTN15677760
• Date of registration: 23/04/2018
• Prospective Registration: Yes
• Primary sponsor: Chang Gung Memorial Hospital
• Public title: The therapeutic effect of autologous peripheral blood-derived stem cell therapy on acute brain infarcts
• Scientific title: 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
• Date of first enrolment: 01/05/2018
• Target sample size: 116
• Recruitment status: Recruiting
• URL: http://isrctn.com/ISRCTN15677760
• Study type: Interventional
• Study design: Prospective single-center interventional trial (Treatment)

Countries of recruitment

Taiwan

Contacts

• Name: Hon-Kan Yip

Key inclusion & exclusion criteria

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)

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Patients with acute ischemic stroke and stationary condition in the convalescent phase
Circulatory System
Acute ischemic stroke

Intervention(s)

For the primary objective of the study, an estimated sample size of 58 study patients in each group is based on the effective size with an a = 0.05, a power of 80%, an improvement of 1.5 in NIHSS score in control vs. 4.0 with EPC therapy and the SD was 4.5. A 10% dropout rate is assumed. Therefore, a total of 116 patients are enrolled within 3 years and randomly allocated into EPC-treatment group (n = 58) and Placebo group (n = 58). Regarding randomization process, random number generated by computers are sealed in envelopes. The envelopes are opened in consecutive order by technicians at core lab who are blinded to case randomization. EPC treatment or not is administered according to randomization results. The ratio of EPC to placebo is 1:1.
Participants in the EPC treatment group receive subcutaneous injection of granulocyte-colony stimulating factor (G-CSF) 5µg/kg twice daily for 4 consecutive days within 7 days after acute stroke. Endothelial progenitor cells (EPCs) are collected at day 5 for 3-4 hours from double lumen sheath inserted at right femoral vein using a machine (COBE Spectra 6.1). The collected EPCs are immediately transfused back to patients themselves with a dose of 3.0x107 EPCs once through internal carotid artery of infarct side using a 6F JR guiding catheter via right radial arterial approach.
Partiicpants in the control group receive guideline-directed standard therapy for ischemic stroke except for cell-based therapy.
All of the data is collected with a blinded method. Decoding the random number needs to be allowed by leader principal investigator. The duration of treatment and follow-up is at least one year and the follow-up period and details in placebo group are the same to those in EPC-treatment group. The participants are followed up at Neurology and Cardiovascular outpatient clinics for safety and efficacy monitoring for 5 years.

Primary Outcome(s)

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

Secondary Outcome(s)

1. Post-therapy 90-day combined endpoint of recurrent stroke or death
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):
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)
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)
5. Any adverse events are recorded within 5 years post-therapy

Secondary ID(s)

Chang Gung Memorial Hospital No. 201700116A0C601

Source(s) of Monetary Support

National Science Council, Chang Gung Medical Research Program

Ethics review

Status:
Approval date:
Contact:

Chang Gung Medical Foundation Institutional Review Board, 14/11/2017, ref: 201700116A0C601

Results

• Results available: Yes
• Date Completed: 30/04/2026