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Bypass Surgery and CD133 Marrow Cell Injection for Treatment of Ischemic Heart Failure

NCT00462774 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-01-16

No results posted yet for this study

Summary

Cell transplantation for treatment of heart failure is a novel field of translational research that offers the perspective of developing curative approaches by regenerating or "rejuvenating" lost and/or diseased myocardium and inducing growth of new blood vessels. Based on the safety and preliminary efficacy testing in previous trials, a stringent efficacy testing will be performed in this study. Sixty patients who had myocardial infarction in the past and now need bypass surgery for ongoing coronary artery disease will undergo either bypass surgery and placebo treatment or bypass surgery and injection of CD133 bone marrow cells directly in the heart muscle. The study will be fully blinded, i.e. neither the patient nor the surgeon knows what substance is injected (placebo or cell product). Patients will be followed for 6 months and various heart function measurements will be performed.

Conditions

  • Coronary Artery Disease With Need for Bypass Surgery
  • Myocardial Ischemia, Angina Pectoris
  • Congestive Heart Failure
  • Previous Myocardial Infarction

Interventions

PROCEDURE

Intramyocardial injection of autologous CD133+ marrow cells

Sponsors & Collaborators

  • Miltenyi Biomedicine GmbH

    collaborator INDUSTRY

  • German Heart Institute

    lead OTHER

Principal Investigators

  • Roland Hetzer, MD, PhD · German Heart Institute

  • Boris Nasseri, MD · German Heart Institute

  • Christof Stamm, MD · German Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Germany

Study Locations

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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 NCT00462774 on ClinicalTrials.gov