Status:
COMPLETED
The Transendocardial Autologous Cells (hMSC or hBMC) in Ischemic Heart Failure Trial (TAC-HFT)
Lead Sponsor:
University of Miami
Collaborating Sponsors:
The Emmes Company, LLC
Conditions:
Stem Cell Transplantation
Ventricular Dysfunction, Left
Eligibility:
All Genders
21-90 years
Phase:
PHASE1
PHASE2
Brief Summary
The technique of transplanting progenitor cells into a region of damaged myocardium, termed cellular cardiomyoplasty, is a potentially new therapeutic modality designed to replace or repair necrotic, ...
Eligibility Criteria
Inclusion
- Diagnosis of chronic ischemic left ventricular dysfunction secondary to MI.
- Be a candidate for cardiac catheterization.
- Been treated with appropriate maximal medical therapy for heart failure or post-infarction left ventricular dysfunction.
- Ejection fraction less than or equal to 50%.
- Able to perform a metabolic stress test.
Exclusion
- Baseline glomerular filtration rate \< 45 ml/min/1.73m2.
- Presence of a mechanical aortic valve or heart constrictive device.
- Documented presence of aortic stenosis (aortic stenosis graded as ≥+2 equivalent to an orifice area of 1.5cm2 or less).
- Documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥+2).
- Evidence of a life-threatening arrhythmia (nonsustained ventricular tachycardia ≥ 20 consecutive beats or complete heart block) or QTc interval \> 550 ms on screening ECG. In addition; patients with sustained or a short run of ventricular tachycardia on ECG or 48 hour Ambulatory ECG during the screening period will be removed from the protocol.
- Documented unstable angina.
- AICD firing in the past 60 days prior to the procedure.
- Contra-indication to performance of a magnetic resonance imaging scan.
- Be eligible for or require coronary artery revascularization.
- Have a hematologic abnormality as evidenced by hematocrit \< 25%, white blood cell \< 2,500/ul or platelet values \< 100,000/ul without another explanation.
- Have liver dysfunction, as evidenced by enzymes (ALT and AST) greater than three times the ULN.
- Have a coagulopathy condition = (INR \> 1.3) not due to a reversible cause.
- Known, serious radiographic contrast allergy.
- Known allergies to penicillin or streptomycin.
- Organ transplant recipient.
- Clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma.
- Non-cardiac condition that limits lifespan to \< 1 year.
- On chronic therapy with immunosuppressant medication.
- Serum positive for HIV, hepatitis BsAg, or non-viremic hepatitis C.
- Female patient who is pregnant, nursing, or of child-bearing potential and not using effective birth control.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00768066
Start Date
August 1 2008
End Date
September 1 2013
Last Update
December 14 2015
Active Locations (1)
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1
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136