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MYOHEART™ (Myogenesis Heart Efficiency and Regeneration Trial)

NCT00054678 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2007-10-15

No results posted yet for this study

Summary

The MyoCell™ implantation using the MyoCath™ delivery catheter system may have the potential to add a new dimension to the management of post-infarct deterioration of cardiac function in subjects with congestive heart failure. Based on pre-clinical studies, implantation of autologous skeletal myoblasts may lead to replacement of non-functioning myocardial scar with functioning muscle and improvement in myocardial performance. Preliminary data in human subjects suggest skeletal myoblast implantation at the time of CABG may lead to the same effects. In principal, myoblast implantation by catheter delivery may offer the same therapeutic benefit. The present clinical study is to be conducted primarily to evaluate the safety of MyoCell™ implantation using the MyoCath™ delivery system and secondarily to evaluate the effect on regional myocardial function post treatment.

Conditions

Interventions

DRUG

MyoCell™

DEVICE

MyoCath™

Sponsors & Collaborators

  • Bioheart, Inc.

    lead INDUSTRY

Principal Investigators

  • Warren Sherman, MD · Columbia University

  • Timothy Henry, MD · Minneapolis Heart / Abbott Northwestern

  • Nicolas Chronos, MD · St. Joseph Hospital / ACRI

  • Steven Elliss, MD · The Cleveland Clinic

  • David Holmes, MD · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2003-02-28
Completion
2007-10-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00054678 on ClinicalTrials.gov