Autologous intra-carotid arterial transfusion of peripheral blood stem cells improves brain ischemia and reperfusion in patients with chronic stroke

Autologous intra-carotid arterial transfusion of peripheral blood stem cells (PBSC) improves brain ischemia and reperfusion – A safety and tolerability study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14654908

Enrollment

Registered

2016-06-28

Start date

2016-01-01

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic ischemic stroke Circulatory System Chronic ischemic stroke

Interventions

All participants receive eight granulocyte-colony stimulating factor (G-CSF) injections of 5 µg/kg sc q12h over a course of four days after admission and endothelial progenitor cell (EPC) collection a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged between 45 and 80 years 2. Chronic ischemic stroke (onset more than 6 months ago) over middle cerebral artery territory (NIHSS score 9-16) 3. Not suitable for surgery or carotid artery stenting

Exclusion criteria

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 adventitious agents (like HIV virus) 6. Myocardial infarction (MI) within 3 months 7. Severe aortic stenosis or mitral stenosis 8. Congestive heart failure, New York Heart Association functional class (NYHA Fc.)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 can not receive regular follow-up 13. Other brain disease (tumor, degenerative disease, infective disease)

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of intracarotid artery autologous endothelial progenitor cells injection is measured through patient interviews and reviewing medical records throughout the five years of the study	—

Secondary

Measure	Time frame
1. Recurrent stroke or death rate is measured by reviewing medical records at 90 days 2. Disability is measured using the modified Rankin Scale score, Barthel Index WAIS-III and CASI National Institutes of Health Stroke Scale (NIHSS) at 24 hours, 72 hours, 30 days and 90 days 3. Brain reperfusion status is measured using Magnetic resonance imaging (Arterial Spin Labeling (ASL) and Dynamic Contrast Enhancement) at 24-72 hours post-therapy and 90 days 4. Brain perfusion defects are evaluated using radionuclear medicine image (brain Tc-99m scan) 24-72 hours post therapy and 90 days 5. Adverse event rate is measured through patient interviews and reviewing medical records at 5 years	—

Measure

Time frame

1. Recurrent stroke or death rate is measured by reviewing medical records at 90 days 2. Disability is measured using the modified Rankin Scale score, Barthel Index WAIS-III and CASI National Institutes of Health Stroke Scale (NIHSS) at 24 hours, 72 hours, 30 days and 90 days 3. Brain reperfusion status is measured using Magnetic resonance imaging (Arterial Spin Labeling (ASL) and Dynamic Contrast Enhancement) at 24-72 hours post-therapy and 90 days 4. Brain perfusion defects are evaluated using radionuclear medicine image (brain Tc-99m scan) 24-72 hours post therapy and 90 days 5. Adverse event rate is measured through patient interviews and reviewing medical records at 5 years

—

Countries

Taiwan

Contacts

Public ContactHon-Kan Yip

han.gung@msa.hinet.net+886 7 7317123 ext. 8300

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026