Status:
COMPLETED
Use of Adult Autologous Stem Cells in Treating People Who Have Had a Heart Attack (The TIME Study)
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Left Ventricular Dysfunction
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
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 i...
Detailed Description
More than 1 million Americans suffer a heart attack each year, resulting in about a 38% mortality rate. Although current treatments are able to stabilize the condition of the heart, none is able to re...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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.
- Exclusion criteria
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00684021
Start Date
July 1 2008
End Date
November 1 2012
Last Update
June 30 2015
Active Locations (5)
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1
University of Florida-Department of Medicine
Gainesville, Florida, United States, 32610
2
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
3
Cleveland Clinic
Cleveland, Ohio, United States, 44195
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232