PROCHYMAL® (cultured adult human mesenchymal stem cells) administration to preserve or improve cardiac function following heart attack
This phase II study aims to test the effectiveness and safety of Prochymal® used to preserve or improve cardiac function when administered within the seven days following initial heart attack. Prochymal® is an investigative therapy whose active ingredient is adult Mesenchymal Stem Cells (MSCs). Research suggests that MSCs interact with the immune cells and travel to different parts of the body, assisting in tissue repair and reduced inflammation. In addition to standard medical therapy, the participants will be randomly assigned to receive either Prochymal® or placebo (a substance with no active ingredient) as a one-time infusion through the vein. Participants will be followed for 2 years after the treatment.
You may be eligible for this study if you:
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Are between 21 and 85 years of age
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Had your first heart attack within the past 7 days
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Have a left ventricular ejection fraction between 30 and 45 percent
You are not eligible for this study if you:
- Have a prior history of heart attack or heart failure
- Have allergies to pork or beef products or allergies to MRI dye
- Require implantable electronic defibrillator or pacemaker
This is a partial list of eligibility and exclusion criteria. To determine if you are eligible to participate, please call the contact phone number provided. If you choose to respond by e-mail, please refer to the title of the study in your correspondence.