Stem Cell Injection to Treat Heart Damage During Open Heart Surgery
Stopped early · Phase 1
Conditions studied: Heart Disease, Ischemic Heart Disease, Coronary Artery Disease, Coronary Artery Disease (CAD)
In brief
Background: \- 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. Objectives: \- To test the safety and effectiveness of bone marrow stromal stem cell injections given during heart surgery to treat heart muscle damage. Eligibility: \- Individuals at least 18 years of age who are scheduled to have open heart surgery for heart artery or vein blockages. Design: * 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....
Key facts
- Study ID
- NCT01557543
- Run by
- National Heart, Lung, and Blood Institute (NHLBI)
- People needed
- 24
- Starts
- 2012-02-29
- Expected to finish
- 2018-06-18
- Last updated by the study team
- 2018-07-05
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Patients who have the following conditions will be excluded from the study:
- Acute MI. Less than three months after recent acute myocardial infarction.
- Unstable angina. Excluded due to the propensity to deteriorate into AMI.
- Bleeding disorder, including history of familial hemophilia, signs and symptoms of easy bruising, petechiae, or platelet count < 80,000 cells/mcL. This disorder may unnecessarily complicate the operative procedure and postoperative recovery.
- Severe respiratory disorder, including acute asthma, chronic bronchitis, severe chronic obstructive lung disease. A disorder that would complicate the operative procedure and postoperative recovery.
- Unable to provide informed consent on this study or on 10-CC-0053.
- Unable to wait 3 weeks for surgery, which is the waiting period for ex-vivo cell expansion.
- Reactive for anti-HIV, Hepatitis B surface antigen, anti-HCV or nucleic acid testing for HIV, Hepatitis B and C. An investigational component accompanying this major surgical procedure in the presence of infection has the potential to increase risk of complications, and manufacturing contaminated products risks contaminating other cellular products in CPS.
- Pregnant or lactating females, due to the highly investigational nature of this study and its unknown effects on a developing fetus.
- Allergic to Gentamicin.
Where it is running
- Suburban Hospital — Bethesda, Maryland, United States
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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