Stem Cell Therapy in Patients With Severe Heart Failure & Undergoing Left Ventricular Assist Device Placement

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Heart Failure

In brief

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 enlargement in the future. The cells will be obtained by aspiration or withdrawal of fluid from your bone marrow from your pelvic bone using a needle and syringe. This would not take place until 24-48 hours prior to your planned left ventricular assist device implantation. During the surgery the surgeons will inject the prepared cells that were taken from your bone marrow and inject it into your heart muscle. This study will test whether receiving your own bone marrow cells directly into your heart will help your heart to recover function after placement of a left ventricular assist device.

Key facts

Study ID

NCT00869024

Run by

University of Minnesota

People needed

25

Starts

2011-11-10

Expected to finish

2016-03-29

Last updated by the study team

2020-03-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University Of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.