Condition: Heart failure
Key Inclusion Criteria
- At least 21 years old and younger than 90 years old
- New York Heart Association Class II or III
- Have an ejection fraction ≥20% and ≤40%
- Diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction
Key Exclusion Criteria
- Baseline glomerular filtration rate <30 ml/min / 1.73m2
- Hematological (blood) abnormality
- Liver dysfunction
Full Study Name
Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy system in Patients With Post Myocardial Infarction Heart Failure (CardiAMP Heart Failure Trial) (IRB no. 48961)
This study focuses on patients who have injured heart muscle due to a heart attack. The purpose of the study is to evaluate the investigational use of Autologous Bone Marrow Mononuclear Cells using the CardiAMP Cell Therapy system. Specifically, researchers aim to determine whether taking cells from the patient's own bone marrow (autologous donation) and transplanting them into injured heart muscle around the area of the heart attack is better than the standard treatment for this condition. Previous studies suggest that stem cells from bone marrow may enhance tissue function by stimulating new tissue growth and recovery.
Participants will be assigned to one of two treatment groups. The first group will receive bone marrow cells during cardiac catheterization. Two-thirds of participants will be assigned to this group. The second group will receive standard of care for heart failure but will undergo a partial procedure (cardiac catheterization and simulated intracardiac injections) for research purposes and will not receive bone marrow cells. One-third of participants will be assigned to this group. Both groups will be involved in a follow-up period that includes safety and efficacy evaluations.