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Safety and Efficacy on Cell-based Therapy in Patients With Recent Large Acute Myocardial Infarction

NCT00691834 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2013-08-13

No results posted yet for this study

Summary

The purpose of this study is to test bone marrow mononuclear cells for patients with recent heart attack who are at high risk of experiencing heart failure. This study drug is made of you own cells. Studies similar to this one have suggested that the use of cell-based transfer after heart attack can improve the recuperation of the heart. The purpose of this study is to assess whether cell transfer can improve the healing of the heart after a heart attack.

Conditions

Interventions

BIOLOGICAL

Intracoronary delivery of unfractionated bone marrow mononuclear cells

Maximal intracoronary cell dose: 50 x 10e7 cells diluted in 10 ml Maximal intracoronary volume: 10 ml (diluted in plasma and culture medium)

BIOLOGICAL

Placebo

Plasma and culture medium (10 ml)

Sponsors & Collaborators

  • Duke Clinical Research Institute

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • Christopher B Granger, MD · Duke Clinical Research Institute

  • Marc E Jolicoeur, MD MSc · Duke Clinical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2009-08-31
Completion
2009-08-31

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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 NCT00691834 on ClinicalTrials.gov