drugset / Trial / NCT00050765

Autologous Cultured Myoblasts (BioWhittaker) Transplanted Via Myocardial Injection

NCT00050765 ↗

Phase 1 Unknown 15 enrolled Bioheart, Inc.
Non-randomizedFactorialOpen-labelTreatment

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.

Timeline

Start
2006-08
Primary completion
—
Completion
2006-08

Drugs

EvaluationDrugModalityDoseRoute
Subject MyoCell™ Cell therapy — Other