Prospective Randomized Study of Mesenchymal Stem Cell Therapy in Patients Undergoing Cardiac Surgery (PROMETHEUS)

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Stem Cell Transplantation, Ventricular Dysfunction, Left

In brief

Heart attacks are a leading cause of death in both men and women in the United States. When a person has a heart attack, blood is unable to reach a certain area of the heart, and if the blood supply is not re-established quickly, that area of the heart can suffer permanent damage. While recovery from a heart attack can be managed through medications and lifestyle changes, these treatments can not reverse the original damage to the heart. Current research is focusing on the development of cell-based therapies using stem cells to repair organs that have been irreversibly damaged by disease. A specific form of stem cells, called adult mesenchymal stem cells (MSCs), has shown promise for heart repair. This study will evaluate the safety and effectiveness of injecting MSCs into the heart to repair and restore heart function in people who have had a heart attack and who are having heart surgery for coronary artery bypass grafting (CABG).

Key facts

Study ID

NCT00587990

Run by

Joshua M Hare

People needed

9

Starts

2007-11-01

Expected to finish

2011-06-01

Last updated by the study team

2019-09-10

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of chronic ischemic heart failure caused by a heart attack
• Scheduled to undergo cardiac surgery for CABG
• Ejection fraction between 15% and 50%
• Presence of an akinetic or dyskinetic region by standard imaging

You may not qualify if…

• Glomerular filtration rate of less than 50 mL/min/1.73m2 at study entry
• Contraindication to performance of an MRI scan
• Bone marrow dysfunction, as evidenced by a 20% or more deviation from normal hematocrit, white blood cell count, or platelet values without another explanation
• A coagulopathy condition not due to a reversible cause (i.e., Coumadin)
• Known, serious radiographic contrast allergy
• Known allergies to penicillin or streptomycin
• Organ transplant recipient
• Clinical history of malignancy within 5 years of study entry (e.g., patients with prior malignancy must be disease free for 5 years), except curatively treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma
• Non-cardiac condition that limits lifespan to less than 1 year
• On chronic therapy with immunosuppressant medication
• Serum positive for HIV, hepatitis B, or hepatitis C
• Female who is pregnant, nursing, or of child-bearing potential and not practicing effective birth control methods

Where it is running

• University of Miami Miller School of Medicine — Miami, Florida, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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