MYOHEART™ (Myogenesis Heart Efficiency and Regeneration Trial)
Public ClinicalTrials.gov record NCT00054678. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I, Open-Label, Non-Randomized, Dose Escalation, Multi Center Study to Assess the Safety and Cardiovascular Effects of Autologous Skeletal Myoblast Implantation by a Transendocardial Catheter Delivery System in Congestive Heart Failure Patients Post Myocardial Infarction(s) With Previous Placement of ICD
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00054678
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 20 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 30 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2003
- Primary completion
- Not listed
- Completion
- Sep 30, 2007
- Last update posted
- Oct 14, 2007
2003 – 2007
United States locations
- U.S. sites
- 5
- U.S. states
- 4
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| SPONSOR: Bioheart, Inc | Sunrise | Florida | 33325 | — |
| American CardioVascular Research Institute | Atlanta | Georgia | 30342 | — |
| Minneapolis Heart Institute / Abbot Northwestern | Minneapolis | Minnesota | 55407 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | — |
| Cleveland Clinic Heart Center | Cleveland | Ohio | 44195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00054678, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 14, 2007 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00054678 live on ClinicalTrials.gov.