Autologous Stem Cells for Cardiac Angiogenesis (FOCUS HF)
Completed · Phase 1 · Has a placebo group
Conditions studied: Ischemic Cardiomyopathy
In brief
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 (LVEF) of less than or equal to 45%. Once the patient meets all inclusion criteria, and no exclusion criteria are found, the subject is consented for the study, and extensive baseline testing is performed at St Luke's Hospital in Houston. Once all baseline testing criteria is met, the patient has their own bone marrow harvested and later that day the subject is taken to a cardiac catheterization lab where left ventricular electromechanical mapping using NOGA software (NOGA mapping) is performed and the processed stem cells are injected under electromechanical guidance into the affected areas of the left ventricle. The patient is usually discharged home the next day and returns for follow up visits at weeks 1, 2, 4, 6, 8, 12, months 6 and 12 and for phone call follow-up at months 4, 5, 7, 8, 9, 10, 11. Patients undergo extensive testing at most of these follow-up visits, including repeat cardiac catheterization with NOGA mapping at month 6 after stem cell injection.
Key facts
- Study ID
- NCT00203203
- Run by
- Texas Heart Institute
- People needed
- 30
- Starts
- 2004-04-01
- Expected to finish
- 2009-11-01
- Last updated by the study team
- 2016-11-28
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Texas Heart Institute/Baylor St. Luke's Medical Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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