Stem Cell Study for Patients With Heart Disease
TerminatedPhase 1, Phase 2NCT00221182
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The purpose of this study is to determine if stem cell therapy with your own cells (autologous cells) delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will relieve your chest pain, increase the blood flow, and/or improve the cardiac contractility (function) by regenerating blood vessels in your heart.
Study details
- Official title
- Phase I / II Clinical Trial Regarding Vascular Regeneration Therapy by Transplantation of Autologous Peripheral Blood Endothelial Progenitor Cells (CD34+ Cells) in No-Option Patients With Chronic Myocardial Ischemia
- Conditions
- Chest Pain
- Chronic Myocardial Ischemia
- Coronary Artery Disease
- Angina
- Myocardial Infarction
- Interventions
- Genetic: Autologous peripheral blood CD34 positive cell therapy
- Sponsor
- Foundation for Biomedical Research and Innovation
- Collaborators
- Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan; Kobe City General Hospital; Okayama University School of Medicine
- Start date
- 2005-09
- Primary completion
- 2009-09
- Sex
- All
- Age range
- from 20 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Japan
- Total sites listed
- 3
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: -Chronic severe CAD patients fulfilling all the following criteria are considered suitable for inclusion in the study. 1. At least 6 months since last episode of myocardial infarction or at least 3 months since initial anginal episode. 2. Patients fulfilling either of the following criteria based on the extent of CAD by coronary angiography and LVEF by echocardiography. * Patients with single vessel CAD and LVEF \< 50% * Patients with multivessel CAD 3. Reversible myocardial ischemia as revealed by sestamibi SPECT stress myocardial scintigraphy. 4. Patients for whom angioplasty and bypass are not indicated because of anatomical or procedural reasons or frequent reocclusion/restenosis following traditional revascularization. 5. Age is between 20 and 80 (at time of consent). 6. Exercise tolerance time (ETT) duration ≥ 3 minutes and \< 13 minutes on a modified Bruce protocol on 2 consecutive tests (\> 24 hours but \< 2 weeks apart), with the difference between the 2 exercise times within 25% of their mean (Patients should not be informed of exercise restrictions required for entry into the study). 7. Patients who can give informed consent themselves in writing. Exclusion Criteria: * Any one of the following exclusion criteria is sufficient to disqualify a patient from the study. 1. Sustained ventricular tachycardia in a 24-hour ECG. 2. Chronic atrial fibrillation. 3. Less than 6 months since last episode of cerebral infarction. 4. Less than 6 months since last coronary angioplasty or less than 3 months since last bypass surgery. 5. Patients with unstable angina, with a treatment rating of 3 in the Braunwald system (refer to 5.4.), but a severity of III and a clinical rating of B or C. 6. Presence of left ventricular thrombus by echocardiography 7. Patients with a malignant tumor\*. 8. Patients with diabetic proliferating retinopathy\*\* (new Fukuda classification BI to BV). 9. Patients with chronic rheumatoid arthritis. 10. Patients with a history of severe allergic reactions or side effects to G-CSF preparations or apheresis. 11. Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes). 12. Patients currently suffering from or having a history of interstitial pneumonitis. 13. Patients for whom cranial MRA reveals cerebral aneurysm. 14. Patients for whom abdominal CT or ultrasonography reveals splenomegaly. 15. Patients with cirrhosis of the liver. 16. Patients who cannot discontinue Warfarin…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00221182