Status:
UNKNOWN
Vescell(TM) for the Treatment of Patients With Severe Anginal Syndrome With or Without Heart Failure
Lead Sponsor:
TheraVitae Ltd.
Conditions:
Angina Pectoris
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Evaluation of an intracoronary injection of ex-vivo generated autologous Angiogenic Cells Precursors (ACPs) to treat patients suffering from severe angina not responsive to maximal drug treatment or n...
Detailed Description
Ten adult patients with severe angina pectoris with or without heart failure and no therapeutic alternative will undergo screening and be treated with an injection of Angiogenic Cell Precursors (ACPs)...
Eligibility Criteria
Inclusion
- Patients with chronic stable angina on maximal medical therapy and an occluded coronary artery or bridging collaterals to a patent distal segment supplying an ischemic viable myocardial region as shown on Sestamibi scan. On coronary angiography, the occluded coronary artery or bridging collaterals must have a patent proximal segment of at least 30 mm with at least one side branch to enable the injection of the VesCellTM if the vessel remains occluded despite the attempted angioplasty efforts (prior to or during the study angiography).
- Patients with occluded target coronary artery (with or without bridging collaterals) that could not be treated with PCI.
- 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 ACPs in the harvested blood).
- Inability to communicate (that may interfere with the clinical evaluation of the patient)
- STEMI during the preceding 3 months
- PCI+stenting during the preceding three 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 temperature above 38.40C for 2 consecutive days
- Patient unlikely to be available for follow-up
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00416663
Start Date
August 1 2007
End Date
August 1 2007
Last Update
September 3 2007
Active Locations (1)
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1
Shaare Zedek Medical Center
Jerusalem, Israel, 91031