Status:
COMPLETED
Use of Adult Autologous Stem Cells in Treating People 2 to 3 Weeks After Having a Heart Attack (The Late 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
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 th...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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.
- 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 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.
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00684060
Start Date
July 1 2008
End Date
February 1 2012
Last Update
July 10 2015
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
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