ACT34-CMI Trial (Autologous Cellular Therapy with CD34+ Cells in Chronic Myocardial Ischemia). Sponsor: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015.
This is a double-blind, prospective, randomized, placebo-controlled study to determine the tolerability, efficacy, safety and dose range of intramyocardial injections of auto-CD34+ stem cells for reduction of angina episodes in patients with refractory chronic myocardial ischemia. Study patients will receive intramyocardial injections of auto stem cells. Patients will be randomized to receive one of two doses of auto stem cells or a placebo dose. Patients will be asked to record the number of angina episodes in a 28-day diary before and after treatment.
You may be eligible for this study if you:
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Are 21 years of age or older
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Have been diagnosed with coronary artery disease (CAD)
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Have failed angioplasty or CABG treatment for angina
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Have refractory anginal symptoms
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Are on maximum tolerated doses of two or more anti-anginal medications for one month prior to screening without control of symptoms.
You are not eligible for this study if you:
- Have been hospitalized with a primary diagnosis of congestive heart failure (CHF) in the prior 6 months
- Have a history of moderate to severe aortic stenosis
- Are unable to participate in a treadmill stress exam for at least 3 minutes
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.