Status:
UNKNOWN
EPC by Intracoronary Injection in Patients With Chronic Stable Angina
Lead Sponsor:
TheraVitae Ltd.
Collaborating Sponsors:
Mahidol University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Study title:A Study for Testing Safety and Efficacy of the administration of Blood-Borne Autologous Endothelial Progenitor Cells to Alleviate Anginal Symptoms and Myocardial Ischemia in Patients with ...
Eligibility Criteria
Inclusion
- Patients with chronic stable angina on maximal medical therapy and an occluded coronary artery supplying an ischemic viable myocardial region as shown on Sestamibi scan. On coronary angiography, the occluded coronary artery must have a patent proximal segment of at least 30 mm with at least one side branch to enable the injection of the EPC if the vessel remains occluded despite the attempted angioplasty efforts.
- Patients are not candidates for or are not willing to undergo CABG surgery.
- Age 18 to 80 years
- Male or non-pregnant, non-lactating female
- Ejection fraction \>35% on Sestamibi
- Sestamibi scan (myocardial perfusion) during exercise or dipyridamole, demonstrating regional reversible ischemia in an area relating to the occluded coronary artery.
- Informed consent obtained and consent form signed
Exclusion
- Patients not satisfying the coronary angiography and Sestamibi criteria
- Patient who received blood transfusions during the previous 4 weeks (to exclude the potential of non-autologous EPCs in the harvested blood).
- Inability to communicate (that may interfere with the clinical evaluation
- Myocardial infarction during the preceding 3 months
- Significant valvular disease or after valve replacement
- After heart transplantation
- Cardiomyopathy
- Renal failure (creatinine 10% above the upper limit according to the hospital normograms)
- Hepatic failure
- Anemia (lower than 11mg/dl.hemoglobin for female and lower than 12 mg/dl for male)
- Abnormal coagulation tests normal \[platelets, PT (INR), PTT\]
- Stroke within the preceding 3 years
- Malignancy within the preceding 3 years
- Concurrent chronic or acute infectious disease
- Severe concurrent medical disease (e.g., septicemia, HIV-1,2/HBV/HCV infections, insulin-dependent diabetes mellitus, systemic lupus erythematosus, multiple sclerosis, amyotrophic lateral sclerosis)
- Chronic immunomodulating or cytotoxic drugs treatment
- Patients who have rectal temp. above 38.40C for 2 consecutive days
- Patient unlikely to be available for follow-up
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00384514
Start Date
July 1 2004
End Date
September 1 2006
Last Update
October 20 2006
Active Locations (1)
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1
Dr. Valentin Fulga
Kiryat Weizmann Science Park, Nes Zionna, Israel, 74140