NCT00054678

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_1

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2003

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

October 15, 2007

Status Verified

October 1, 2007

First QC Date

February 6, 2003

Last Update Submit

October 11, 2007

Conditions

Congestive Heart FailureCoronary Artery DiseaseMyocardial Infarction

Keywords

Myocardial infarctionHeart diseaseEndoventricularCardiovascularInterventionalICDHeart failureImplantable Cardioverter Defibrillator

Outcome Measures

Primary Outcomes (1)

  • To assess the safety of Myocel following implantation into myocardial scar tissue of subjects with congestive heart failure who have experienced previous MI.

Interventions

MyoCell™DRUG
MyoCath™DEVICE

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Defined region of myocardial dysfunction related to previous myocardial infarction(s) involving the anterior, lateral, posterior or inferior walls, \> 12 weeks (84 days) old at the scheduled time of MyoCell™ implantation
  • Patients who have had prior placement of an Implantable Cardioverter Defibrillator (ICD) which must be in place at least one month (30 days) prior to MyoCell™ implantation
  • New York Heart Association (NYHA) Symptom Class II or III on optimal medical therapy
  • Age \> 30 and \< 80 years old
  • Need for revascularization has been ruled out by coronary angiogram or noninvasive stress testing within six months (180 days) of screening
  • Able to undergo surgical biopsy of the skeletal muscle and successful culture of the harvested myoblasts Target region wall thickness \> 6 mm by Echocardiography
  • Left ventricular ejection fraction \> 20% and \< 40% by Radionuclide Ventriculography or Left Ventricular Angiography at screening
  • Able to give written informed consent
  • Able to walk a minimum distance of 300 meters during the 6-minute walk test
  • Myocardial infarction within 12 weeks (84 days) prior to investigational procedure
  • New York Heart Association Symptom Class I or IV
  • Coronary Artery Bypass Grafting (CABG) within 3 months (90 days) prior to scheduled MyoCell™ implantation
  • Percutaneous Coronary Intervention (PCI) within 6 months (180 days) prior to MyoCell™ implantation
  • Canadian Heart Classification of angina \> Class II or unstable angina
  • Any cardiac valve replacement
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

SPONSOR: Bioheart, Inc

Sunrise, Florida, 33325, United States

Location

American CardioVascular Research Institute

Atlanta, Georgia, 30342, United States

Location

Minneapolis Heart Institute / Abbot Northwestern

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Cleveland Clinic Heart Center

Cleveland, Ohio, 44195, United States

Location

Related Links

MeSH Terms

Conditions

Heart FailureCoronary Artery DiseaseMyocardial InfarctionHeart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Warren Sherman, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Timothy Henry, MD

    Minneapolis Heart / Abbott Northwestern

    PRINCIPAL INVESTIGATOR

  • Nicolas Chronos, MD

    St. Joseph Hospital / ACRI

    PRINCIPAL INVESTIGATOR

  • Steven Elliss, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

  • David Holmes, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 6, 2003

First Posted

February 7, 2003

Study Start

February 1, 2003

Study Completion

October 1, 2007

Last Updated

October 15, 2007

Record last verified: 2007-10

Locations

US(5)