Phase 1
N=30
Autologous Stem Cells for Cardiac Angiogenesis (FOCUS HF)
Ischemic Cardiomyopathy
Bottom Line
View on ClinicalTrials.gov: NCT00203203 ↗Enrolled (actual)
30
Serious AEs
60.0%
Results posted
Jan 2013
Primary outcome: Primary: Safety of Autologous-bone-marrow Injections — 1; 1; 0; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Intramyocardial Injection of stem cells via NOGA Mapping (Device); Control, then Stem Cell Therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Texas Heart Institute
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of Autologous-bone-marrow Injections |
1; 1; 0; 1; 1; 0 | — |
| SECONDARY Canadian Cardiovascular (CCS) Angina Score |
3; 3; 2.2; 2.1; 2.6; 1.8 | — |
| SECONDARY New York Heart Association (NYHA)Classification |
2.6; 2.3; 1.9; 2; 2.4; 1.8 | — |
| SECONDARY Myocardial Oxygen Consumption (MVO2) |
14.8; 14.7; 15.7; 15.5; 15.6; 15.8 | — |
| SECONDARY Echocardiography (EF)Percent (%) |
39; 37; 41; 38; 42; 40 | — |
| SECONDARY Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 Slope) |
29.8; 32.7; 32.8; 31.8 | — |
| SECONDARY Echocardiography Wall Motion Score Index (WMSI) |
1.7; 1.7; 1.6; 1.7 | — |
| SECONDARY Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%) |
43; 41.5; 46.8; 43.2; 47.8; 44 | — |
| SECONDARY Angiography Left Ventricular Ejection Fraction (LVEF) Percent (%) |
40; 37.5; 40.9; 42 | — |
| SECONDARY Left Ventricular End-Diastolic Volume (LVEDV) |
132.2; 133.2; 125.7; 123.9; 120.0; 123.9 | — |
| SECONDARY Left Ventricular End-Systolic Volume (LVESV) (ml) |
81.7; 92.9; 74.4; 83.2; 71.8; 74 | — |
| SECONDARY Endocardial Unipolar Voltages (UPV) |
10.2; 10.5; 10.1; 10.8 | — |
| SECONDARY Linear Local Shortening (LLS) |
12.1; 10.5; 9.1; 10.8 | — |
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 (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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- AGe 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
Data sourced from ClinicalTrials.gov (NCT00203203). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.