CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cellsbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00869024
NCT00869024Phase 2Completed
CompareCT.gov

AsseSsment of Efficacy, Safety and Utility of intRa myocardiAl iNjection of Stem Cells in Patients With End Stage Heart Failure Undergoing LVAD Implantation (ASSURANCE)

University of Minnesota·interventional·Posted Mar 25, 2009·Updated Mar 13, 2020

In Brief

A Phase 2 clinical trial evaluating Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells for Heart Failure. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 25, 2009
Enrollment StartNov 10, 2011
Primary CompletionMar 29, 2016
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 17.3 years ago

Interventions

Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cellsbiological

Ten separate injections will be delivered into the LV free wall (20 X 106 cells / 400 micro lit).