Phase 2 N=25 Randomized Quadruple-blind Treatment

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

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT00869024 ↗

Enrolled (actual)

Serious AEs

80.0%

Results posted

Mar 2020

Primary outcome: Primary: Safety of Cell Delivery — 1; 0 adverse events

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety of Cell Delivery	1; 0	—
PRIMARY Improvement in Myocardial Viability by PET/CT Scan	14; 4; 14; 4; 15; 4	—
PRIMARY Combined End Points of Death	2; 3	—
SECONDARY Number of Participants Turned Down Without Meeting LVAD Stopping Rules	12; 2	—
SECONDARY Change in Left Ventricular Dimensions	-0.49; -0.57; -0.73; -0.62	—
SECONDARY Histological Assessment	—	—

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 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.

Eligibility Criteria

Inclusion Criteria

Severe LV dysfunction with EF 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00869024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.