Status:
COMPLETED
Intramyocardial Injection of Autologous Aldehyde Dehydrogenase-Bright Stem Cells for Therapeutic Angiogenesis (FOCUS Br)
Lead Sponsor:
Texas Heart Institute
Collaborating Sponsors:
CHI St. Luke's Health, Texas
Aldagen
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Recent studies have suggested that it may be possible to grow new blood vessels (angiogenesis) to supply the heart muscle that is currently not getting enough blood. One theory is that a certain type ...
Detailed Description
This is a phase I, double blind trial to evaluate the use of Aldehyde Dehydrogenase-Bright (ALDHbr) in ischemic cardiomyopathy patients. The study hypothesis is that transendocardial injections of aut...
Eligibility Criteria
Inclusion
- Canadian cardiovascular (CV) Class II-IV angina and/or congestive heart failure (CHF) symptoms
- Ejection fraction less than or equal to 45%
- Reversible perfusion defect on single photon emission computed tomography (SPECT)
- Coronary artery disease (CAD) unable to be corrected by surgery (bypass) or intervention (stent)
- Able to walk on treadmill
- Hemodynamically stable
Exclusion
- Age less than 18 or greater than 70
- Atrial fibrillation
- Severe valve disease
- History of cancer in last 5 years
- HIV positive; hepatitis B or C positive.
- Left ventricular wall thickness less than 8 mm
- Recent heart attack within the last 30 days
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00314366
Start Date
April 1 2006
End Date
August 24 2023
Last Update
April 23 2024
Active Locations (1)
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1
Texas Heart Institute/Baylor St. Luke's Medical Center
Houston, Texas, United States, 77030