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To Assess Safety and Efficacy of Myoblast Implantation Into Myocardium Post Myocardial Infarction

NCT00526253 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2017-07-21

No results posted yet for this study

Summary

This study injects a person's own stem cells into heart muscle tissue after a person has one or more heart attacks. The purpose of the study is whether the stem cells will improve a patient's heart performance.

Conditions

  • Congestive Heart Failure

Interventions

BIOLOGICAL

MyoCell

Patient will receive injections of cultured, expanded skeletal myoblasts into the myocardium at a dose of 400 million cells.

BIOLOGICAL

MyoCell

Patient will receive injections of cultured, expanded skeletal myoblasts into the myocardium at a dose of 800 million cells.

PROCEDURE

Hypothermosol

After the cell culture period of time has passed, patient's myocardium will be injected with the transport media alone. Patient will not receive any cultured myoblasts during these injections.

Sponsors & Collaborators

  • Bioheart, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2019-02-28

Countries

  • United States

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 NCT00526253 on ClinicalTrials.gov