Use of Adult Autologous Stem Cells in Treating People Who Have Had a Heart Attack (The TIME Study)

Completed · Phase 2 · Has a placebo group

Conditions studied: Left Ventricular Dysfunction

In brief

Heart attacks are a leading cause of death for both men and women in the United States. A heart attack occurs when blood flow to the heart is restricted, commonly due to a blood clot that has formed in one of the coronary arteries. If the clot becomes large enough, blood flow to the heart can be blocked almost completely and the heart muscle in that area can suffer permanent injury or death. Although a percutaneous coronary intervention (PCI) can be used to open up the blocked artery and restore blood flow to the heart muscle, there may be a significant amount of heart tissue that has been irreversibly damaged. Recent studies have shown that adult stem cells from bone marrow may be able to improve heart function after a heart attack. This study will evaluate the safety and effectiveness of using adult stem cells for improving heart function in people who have had a recent heart attack and a PCI.

Key facts

Study ID

NCT00684021

Run by

The University of Texas Health Science Center, Houston

People needed

120

Starts

2008-07-01

Expected to finish

2012-11-01

Last updated by the study team

2015-06-30

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients at least 21 years of age
• Patients with first acute MI with successful primary percutaneous coronary intervention (PCI) in an artery at least 2.5 mm in diameter within 24 hours of onset of symptoms.
• No contraindications to undergoing cell therapy procedure within three to seven days following AMI and PCI.
• Hemodynamic stability as defined as no requirement for IABP, inotropic or blood pressure supporting medications.
• Ejection fraction following reperfusion with PCI <=45% as assessed by echocardiography.
• Consent to protocol and agree to comply with all follow-up visits and studies.
• Women of child bearing potential willing to use an active form of birth control.

You may not qualify if…

• Patients will be excluded from the study if they meet any of the following conditions:
• History of sustained ventricular arrhythmias not related to their AMI (evidenced by previous holter monitoring and/or medication history for sustained ventricular arrhythmias in patient's medical chart).
• Require CABG or PCI due to the presence of residual coronary stenosis >70% luminal obstruction in the non-infarct related vessel (Additional PCI of non-culprit vessels may be performed prior to enrollment).
• History of any malignancy within the past five years excluding non-melanoma skin cancer or cervical cancer in-situ.
• History of chronic anemia (hemoglobin (Hb) <9.0 mg/dl).
• History of thrombocytosis (platelets >500k).
• History of thrombocytopenia in the absence of recent evidence that platelet counts are normal
• Known history of elevated INR (PT) or PTT.
• Life expectancy less than one year.
• History of untreated alcohol or drug abuse.
• Currently enrolled in another investigational drug or device trial
• Previous CABG.
• Previous MI resulting in LV dysfunction (LVEF <55%)
• History of stroke or transient ischemic attack (TIA) within the past six months.
• History of severe valvular heart disease (aortic valve area <1.0 cm2 or >3+ mitral regurgitation).
• Pregnancy or breast feeding
• Subjects with a known history of HIV, or has active hepatitis B,active hepatitis C, or active TB
• Patients with active inflammatory or autoimmune disease on chronic immuno-suppressive therapy.
• Contraindications to cMRI.
• Previous radiation to the pelvis with white blood cell count (WBC) and platelet counts below hospital specific normal values.
• Women child bearing potential not willing to practice an active form of birth control.
• Chronic liver disease that might interfere with survival or treatment with cell therapy.
• Chronic renal insufficiency as defined by a creatinine ≥ 2.0 mg/dL or requires chronic dialysis.

Where it is running

• University of Florida-Department of Medicine — Gainesville, Florida, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Texas Heart Institute — Houston, Texas, United States

Full record on ClinicalTrials.gov

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