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Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure

NCT00383630 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-04-17

Study results available
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Summary

Heart failure is a condition in which the heart is unable to pump enough blood to the body's other organs. A heart transplant may be necessary for some individuals with end-stage heart failure. Left ventricular assist devices (LVADs) can assist the heart in pumping blood, and are commonly used until a donor heart becomes available. Bone marrow cells injected into the heart may improve heart function and may lead to earlier LVAD removal. The purpose of this study is to evaluate the safety and effectiveness of injected bone marrow cells in improving heart function in individuals with LVADs who are awaiting heart transplants.

Conditions

  • Heart Failure, Congestive

Interventions

BIOLOGICAL

Intramyocardial injection of bone marrow mononuclear cells

6mL of bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.

BIOLOGICAL

Intramyocardial injection of CD34+ selected bone marrow mononuclear cells

6mL of CD34+ selected bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.

DEVICE

LVAD alone

LVAD implantation without any intramyocardial injection of bone marrow cells.

Sponsors & Collaborators

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

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Yoshifumi Naka, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00383630 on ClinicalTrials.gov