MedTrace Logo

Effectiveness of Stem Cell Treatment for Adults With Ischemic Cardiomyopathy (The FOCUS Study)

NCT00824005 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2015-07-01

Study results available
· View outcomes & findings →

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.

Conditions

  • Chronic Ischemic Heart Disease
  • Left Ventricular Dysfunction
  • Angina
  • Ischemic Cardiomyopathy

Interventions

BIOLOGICAL

Adult stem cells

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

BIOLOGICAL

Placebo

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

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Cardiovascular Cell Therapy Research Network (CCTRN)

    collaborator UNKNOWN

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Robert Simari, MD · Cardiovascular Cell Therapy Research Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-11-30
Completion
2012-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00824005 on ClinicalTrials.gov