Stem Cell Injection to Treat Heart Damage During Open Heart Surgery
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|ClinicalTrials.gov Identifier: NCT01557543|
Recruitment Status : Active, not recruiting
First Posted : March 19, 2012
Last Update Posted : April 4, 2018
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Disease Ischemic Heart Disease Coronary Artery Disease Coronary Artery Disease (CAD)||Other: Cell Therapy||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 29, 2012|
|Actual Primary Completion Date :||July 25, 2017|
|Estimated Study Completion Date :||December 30, 2020|
Other: Cell Therapy
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)|