Stem Cell Injection to Treat Heart Damage During Open Heart Surgery
- Bone marrow stromal stem cells (also known as mesenchymal stem cells) have been isolated and are found to make large amounts of growth factors. Because they make growth factors, these cells can help re-grow tissue and encourage repair of damaged tissue. Tests on damaged heart muscle suggest that injecting these cells directly into damaged heart muscle can improve heart function. Researchers want to give stem cells to people who are having open heart surgery to see if they can help to repair heart muscle damage.
- To test the safety and effectiveness of bone marrow stromal stem cell injections given during heart surgery to treat heart muscle damage.
- Individuals at least 18 years of age who are scheduled to have open heart surgery for heart artery or vein blockages.
- Participants will be screened with a physical exam and medical history. Blood and urine samples will also be collected.
- Participants will have bone marrow taken from both hip bones about 3 weeks before the heart surgery.
- During the surgery, the stromal stem cells collected from the bone marrow will be given into the damaged portion of the heart muscle. The rest of the heart surgery will be performed according to standard procedures.
- After the surgery, participants will be monitored for complications from the stromal stem cells.
- Participants will have heart function tests to see if the stromal stem cell treatments were effective.
|Heart Disease Ischemic Heart Disease Coronary Artery Disease Coronary Artery Disease (CAD)||Other: Cell Therapy||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Preliminary Assessment of Direct Intra-Myocardial Injection of Autologous Bone Marrow-derived Stromal Cells on Patients Undergoing Revascularization for CAD With Depressed Left Ventricular Function|
- To evaluate the safety and feasibility of direct intra-myocardial injection of autologous bone marrow stromal cells (BMSCs) in adult subjects undergoing coronary artery bypass graft (CABG) or transmyocardial revascularization (TMR).
- To assess if direct intra-myocardial injection of autologous BMSCs improves the patient's cardiac function, quality of life, and reduces cardiac events compared to historical controls at three and six months after intervention.
|Study Start Date:||February 27, 2012|
|Estimated Study Completion Date:||December 30, 2020|
|Estimated Primary Completion Date:||December 30, 2017 (Final data collection date for primary outcome measure)|
Other: Cell Therapy
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557543
|United States, Maryland|
|Bethesda, Maryland, United States, 20814|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Pamela G Robey, Ph.D.||National Institute of Dental and Craniofacial Research (NIDCR)|