Status:
COMPLETED
Autologous Stem Cells for Cardiac Angiogenesis (FOCUS HF)
Lead Sponsor:
Texas Heart Institute
Collaborating Sponsors:
CHI St. Luke's Health, Texas
Conditions:
Ischemic Cardiomyopathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This is a phase 1, single-blind trial to evaluate using autologous bone marrow mononuclear stem cells in ischemic cardiomyopathy patients. The patients must have a Left Ventricular Ejection Fraction (...
Detailed Description
This is a phase 1, single-blind trial to evaluate the use of autologous bone marrow mononuclear stem cells in ischemic cardiomyopathy patients. The study hypothesis is that transendocardial injections...
Eligibility Criteria
Inclusion
- LVEF less than 45%
- Functional class III or IV angina
- At least 7% reversibility by Single Photon Emission Computed Tomography (SPECT) nuclear study
- there are additional inc. criteria
Exclusion
- AGe \<18 or \>70 years of age
- Constant atrial fibrillation
- Left ventricular (LV) thrombus
- History of malignancy in the last 5 years
- LV wall thickness of \< 8 mm at the target site
- there are additional exclusion criteria
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00203203
Start Date
April 1 2004
End Date
November 1 2009
Last Update
November 28 2016
Active Locations (1)
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1
Texas Heart Institute/Baylor St. Luke's Medical Center
Houston, Texas, United States, 77030