NCT00526253

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

A Multicenter Study to Assess the Safety and Cardiovascular Effects of Myocell™ Implantation by a Catheter Delivery System in Congestive Heart Failure Patients Post Myocardial Infarction(s)

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Bioheart, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Autologous myoblasts are harvested from a patient's skeletal muscle tissue. The myoblasts are isolated and expanded in culture in a closed system. When a sufficient number of cells are estimated they are taken from culture, packaged in a suspension and sent to the patient's interventionalist. The interventionalist uses an injection catheter via femoral artery to inject the myoblasts directly into the myocardium.

Conditions

• Congestive Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-09-01
• Primary completion: 2019-02-01
• First posted: 2007-09-10
• Last updated: 2017-07-21

Locations

33 sites across 1 country: United States