CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 92 enrolled
Drug / intervention
Adult stem cells +1 morebiological
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/NCT00824005
NCT00824005Phase 2Completed
CompareCT.gov

Randomized, Controlled, Phase II, Double-Blind Trial of Intramyocardial Injection of Autologous Bone Marrow Mononuclear Cells Under Electromechanical Guidance for Patients With Chronic Ischemic Heart Disease and Left Ventricular Dysfunction

The University of Texas Health Science Center, Houston·interventional·Posted Jan 16, 2009·Updated Jul 1, 2015

In Brief

A Phase 2 clinical trial evaluating Adult stem cells and Placebo for Chronic Ischemic Heart Disease and 3 related conditions. Completed, enrolled 92 participants across 5 sites.

Detailed Summary

Coronary artery disease (CAD) is a common disorder that can lead to heart failure. Not all people with CAD are eligible for today's standard treatments. One new treatment approach uses stem cells-specialized cells capable of developing into other types of cells-to stimulate growth of new blood vessels for the heart. This study will determine the safety and effectiveness of withdrawing stem cells from someone's bone marrow and injecting those cells into the person's heart as a way of treating people with CAD and heart failure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Ischemic Heart Disease, Left Ventricular Dysfunction, Angina, Ischemic Cardiomyopathy
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), Cardiovascular Cell Therapy Research Network (CCTRN)

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 16, 2009
Enrollment StartMar 1, 2009
Primary CompletionNov 1, 2011
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.5 years ago

Interventions

Adult stem cellsbiological

Single procedure of intramyocardial electromechanical-guided injection of approximately 100 million bone marrow mononucleated cells (BM-MNCs), administered in 15 different injection sites

Placebobiological

Single procedure of intramyocardial electromechanical-guided needle insertions and injection of 5% human serum albumin and saline in 15 different injection sites