Use of Adult Autologous Stem Cells in Treating People 2 to 3 Weeks After Having a Heart Attack (The Late TIME Study)

Completed · Phase 2 · Has a placebo group

Conditions studied: Left Ventricular Dysfunction

In brief

More than 1 million Americans suffer heart attacks each year. Although current treatments are able to stabilize the condition of the heart, none is able to restore heart function as it was prior to the heart attack. Adult stem cells, which are immature cells that can become many different types of cells, may offer a potential means of reversing or preventing permanent damage caused by a heart attack. Recent studies have shown promise in using adult stem cells from bone marrow to reverse damage to the heart muscle caused by a heart attack, but more research is needed to assess the safety and effectiveness of stem cell use and to discover the best time to administer treatment. This study will evaluate the safety and effectiveness of using adult stem cell infusions 2 to 3 weeks after a heart attack for improving heart function in people who have had a recent heart attack and a common procedure called a percutaneous coronary intervention (PCI).

Key facts

Study ID

NCT00684060

Run by

The University of Texas Health Science Center, Houston

People needed

87

Starts

2008-07-01

Expected to finish

2012-02-01

Last updated by the study team

2015-07-10

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 and subsequent successful primary percutaneous coronary intervention (PCI) in an artery at least 2.5 mm in diameter occurring two to three weeks before recruitment.
• No contraindications to undergoing cell therapy procedure within two to three weeks 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 tuberculosis (TB)
• Patients with active inflammatory or autoimmune disease on chronic immunosuppressive 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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