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Autologous Cultured Myoblasts (BioWhittaker) Transplanted Via Myocardial Injection

NCT00050765 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2006-03-08

No results posted yet for this study

Summary

MyoCell™ implantation by epicardial injection during CABG surgery has the potential to add a new dimension to the management of post-infarct deterioration of cardiac function. Based on existing non-clinical studies and clinical reports, implantation of autologous skeletal myoblasts appears to lead to the replacement of non-functioning myocardial scar with functioning muscle and appears to improve myocardial performance relative to case without myoblast implantation. In a few investigational patients, myoblast implantation can be, and has been, done in conjunction with CABG and appears to have the potential to provide for additive treatment during surgery. The present study is being conducted to evaluate more fully the safety of MyoCell™ implantation via epicardial injection during CABG surgery and its effect on regional myocardial function.

Conditions

Interventions

DRUG

MyoCell™ Autologous Myoblasts

Sponsors & Collaborators

  • Bioheart, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2006-08-31
Completion
2006-08-31

Countries

  • United States

Study Locations

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Entities

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 NCT00050765 on ClinicalTrials.gov