Status:
COMPLETED
Stem Cell Therapy in Patients With Severe Heart Failure & Undergoing Left Ventricular Assist Device Placement
Lead Sponsor:
University of Minnesota
Conditions:
Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine if the delivery of cells just after implantation of left ventricular assist device will help to improve the pumping function of your heart and minimize heart ...
Detailed Description
Patients who meet the inclusion and exclusion criteria and agree to participate will be enrolled in the study. All the patients will have a baseline EKG, Laboratory tests, 2D ECHO and PET/CT imaging.D...
Eligibility Criteria
Inclusion
- Severe LV dysfunction with EF \< 30% with cardiomyopathy ( Ischemic and non ischemic)
- NYHA Class III and IV
- No revascularization options available
- LVAD placement as destination therapy or bridging to transplantation
- Age between 18-80 years
Exclusion
- History of recent malignancy( less than one year) .
- Unstable hemodynamics at the time of the implant; defined by need for increasing vasopressor medication in the last 24 hours or blood pressure \< 70 systolic, or cardiac index \< 1.3 liters/min.
- Coronary anatomy suitable for revascularization at the time of surgery
- Pregnancy confirmed by positive urine test
- Lactating mothers
- Renal failure with serum creatinine \>3.0, or are receiving chronic dialysis support.
- Inability to undergo PET/CT imaging.
- A history of any significant recent bleeding disorder or coagulation profile of concern for acute bleeding, such as INR \>2.0 (not on anticoagulant), platelet count \<100,000, or hemoglobin \<8.0 gr/dl.
- Patients with known infectious disease (Hepatitis, HIV) etc.
- Patients with three times or more of the upper limits of normal enzymes.
- \-
Key Trial Info
Start Date :
November 10 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2016
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00869024
Start Date
November 10 2011
End Date
March 29 2016
Last Update
March 13 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Of Minnesota
Minneapolis, Minnesota, United States, 55455