Mode
Text Size
Log in / Sign up
Phase 1 N=30 Randomized Single-blind Treatment

Autologous Stem Cells for Cardiac Angiogenesis (FOCUS HF)

Ischemic Cardiomyopathy

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

Back to search