Safety and Effects of Implanted (Autologous) Skeletal Myoblasts (MyoCell) Using an Injection Catheter = SEISMIC Trial

NCT00375817 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2007-10-12

No results posted yet for this study

Summary

To assess the efficacy and safety of MyoCell therapy on myocardial function in congestive heart failure patients, post-myocardial infarction

Conditions

Interventions

PROCEDURE

Myoblasts injection with MyoCath catheter

Sponsors & Collaborators

  • Bioheart, Inc.

    lead INDUSTRY

Principal Investigators

  • Jozef - Bartunek, MD · Cardiovascular Center, Aalst

  • Anthony - Gershlick, MD · Glenfield Hospital, University Hospitals of Leicester

  • Christoph - Hehrlein, MD · University of Freiburg

  • Carlos - Macaya, MD · Hospital Clinico San Carlos, Spain

  • Christoph - Nienaber, MD · University, Rostock, Germany

  • Nicholas - Peters, MD · St Mary's Hospital & Imperial College, London

  • Joachim - Schofer, MD · Universitaires Herzzentrum Hamburg, Germany

  • Patrick - Serruys, MD · Thorax Centre-Erasmus University, The Netherlands

  • Tomasz - Siminiak, MD · Cardiac & Rehabilitation Hospital at Kowanowko,Poland

  • Peter - Smits, MD · Medisch Centrum, Rijnmond Zuid, The Netherlands

  • J. - Waltenberger, MD · Academisch Ziekenhuis Maastrict, The Netherlands

  • Walter Van Mieghem, MD · ZOL Campus St. Jan, Genk, Belgium

  • Victor Legrand, MD · University Hospital, Liege, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2005-11-30
Completion
2008-01-31

Countries

  • United States

Study Locations

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Entities

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 NCT00375817 on ClinicalTrials.gov