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Intramyocardial Transplantation of Bone Marrow Stem Cells in Addition to Coronary Artery Bypass Graft (CABG) Surgery

NCT00950274 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2020-07-15

No results posted yet for this study

Summary

In spite of the fact that the post-myocardial infarction survival rate has improved with recent medical advances, reduced heart function attributed to irreversible loss of viable cardiomyocytes is still a major clinical problem.

The aim of the current study is to determine whether intramyocardial injection of autologous CD133+ bone marrow stem cells yields a functional benefit in addition to coronary artery bypass graft (CABG) surgery in patients with chronic ischemic coronary artery disease.

Conditions

Interventions

DRUG

CD133+ autologous bone marrow stem cell

Intramyocardial injection of 5 mL CD133+ cells (0.5-5x10e6 cells) suspended in physiological saline + 10% autologous serum intramyocardially during CABG surgery

DRUG

Placebo

Intramyocardial injection of 5 mL of physiological saline + 10% autologous serum intramyocardially during CABG surgery

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • Miltenyi Biotec B.V. & Co. KG

    lead INDUSTRY

Principal Investigators

  • Gustav Steinhoff, M.D. · Universitiy of Rostock

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2016-03-31
Completion
2017-09-30

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

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 NCT00950274 on ClinicalTrials.gov