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Status unknownNCT00626314CAuSMIc IIUpdated Feb 29, 2008

Study to Assess the Efficacy and Safety of Transplanting Autologous Skeletal Myoblasts, Into Infarcted Heart, Using an Catheter Delivery System

A Phase 2 interventional study of myoblast and sham in Ischemic Cardiomyopathy, sponsored by Mytogen, Inc.. Status unknown at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-02-29.

Sponsored by Mytogen, Inc. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2008), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
21 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and effectiveness of injecting myoblasts (grown from your own skeletal muscle), using a catheter device, directly into the damaged heart muscle for treatment of severe heart failure.

Read the detailed description

Given the limited treatment options available to patients with congestive heart failure, there is a need for alternative therapies. Autologous skeletal myoblast transplantation has been demonstrated in pre-clinical studies to be a safe and effective treatment of heart failure. Initial clinical studies have shown that autologous myoblasts can be delivered into infracted myocardium by both direct epicardial and endomyocardial injection. However, autologous skeletal myoblast transplantation via percutaneous endomyocardial injection has the potential to play a significant role in such congestive heart failure patients without the need for surgical risk and general anesthesia. Thus, a Phase 2 clinical trial is proposed in order to evaluate the effectiveness of autologous myoblast delivered by endomyocardial injection for the treatment congestive heart failure.

02

Conditions studied

  • Ischemic Cardiomyopathy

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03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's planned enrollment of 165 is above the median of 51 across 609 interventional studies indexed under Cardiomyopathies.

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Lead sponsor

This is the only study on the registry with Mytogen, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subjects with ischemic cardiomyopathy and previous myocardial infarction
  2. New York Heart Association Classification III - ambulatory Class IV
  3. Ejection fraction \< 35% as determined by any method at baseline evaluation
  4. Subjects could be considered for enrollment if CRT placement has occurred greater than three months previously with no clinical improvement, CRT settings are judged to be optimized and the subject continues to meet all other inclusion criteria (inadequate-responders).
  5. Documentation of ineligibility for coronary revascularization and/or valve repair/ replacement by review of recent left heart catheterization (within six months of baseline).
  6. Receiving optimally tolerated doses of standard, stable pharmacotherapy, including angiotensin-converting enzyme inhibitors, unless intolerant or contra-indicated, diuretics, ß-receptor blockers for at least one month prior to enrollment
  7. Severe myocardial perfusion abnormality documented by SPECT imaging, involving at least 1/3 of a vascular territory, as confirmed by core lab.

Exclusion criteria

Exclusion Criteria:

  1. Age \< 21 years or > 75 years.
  2. Significant coronary stenosis, as determined by the Investigator, which may potentially require percutaneous or surgical revascularization within 12 weeks of enrollment.
  3. Recent (within 4 weeks), documented acute coronary syndrome, i.e. (Q wave or non-Q wave infarction) or hospitalization for unstable angina.
  4. Documented cerebrovascular accident (stroke) or TIA within 60 days.
  5. Left ventricular thrombus (mobile or mural-based) as evidenced by ventriculogram or echocardiography.
  6. Clinically significant electrocardiographic abnormalities that may interfere with subject safety during the intracardiac mapping and injection procedure. Patients with right bundle branch block with basal septal infarction.
  7. Subjects with CRT placement within three months of enrollment or intent to insert CRT, or CRT settings not judged to be optimized
  8. High grade atrioventricular block not corrected by permanent pacemaker or ICD.
  9. Frequent or recurrent, ventricular tachycardia in absence of an ICD.
  10. Atrial fibrillation with uncontrolled ventricular response
  11. Significant uncorrected valvular disease, which results in additional hemodynamic compromise and/or would require valvular repair or replacement. Patients with severe aortic stenosis or status-post mitral or aortic mechanical valve replacement.
  12. Severe peripheral vascular disease, such that femoral access would be prohibited.
  13. INR > 1.5 in absence of coumadin or partial thromboplastin time (PTT) >20% above ULN, or thrombocytopenia (platelet count \< 75,000).
  14. Significant renal dysfunction (e.g., creatinine >2.5 mg/dL) or liver disease (e.g., serum glutamic-oxaloacetic transaminases / aspartate aminotransferase SGOT/AST or serum glutamic-pyruvic transaminases/alanine aminotransferase SGPT/ALT > 4 x upper limit of normal [ULN]).
  15. Currently enrolled, or have been enrolled within 30 days, in another investigational drug or device study that has not completed the protocol required follow-up period.
  16. Subjects who have received a prior investigational stem cell or angiogenic agent.
  17. Subjects who have tested positive for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and/or Hepatitis C Virus (HCV).
  18. History of skeletal muscle disease, e.g. family history of acute or chronic skeletal muscle disease including infectious, drug-induced, familial, autoimmune and idiopathic myopathies.
  19. Creatine phosphokinase (CK) or lactate dehydrogenase elevated greater than three times normal or unexplained elevations of CK.
  20. Female subjects who are pregnant or nursing or any subject with reproductive capabilities unwilling to use effective birth control for the duration of the study period.
  21. Evidence of concurrent infection of any type (e.g. Elevated white blood cell count {WBC>13,000}, temperature of >38.5 C, or infiltrate on chest x-ray).
  22. Any other major illness, which, in the Investigator's judgment, will interfere with the subject's ability to comply with the protocol, compromises subject safety, or interferes with the interpretation of the study results.
  23. Idiopathic Cardiomyopathy, hypertrophic cardiomyopathy
  24. Subjects with ventricular wall thickness in the infarct zone of \< 5 mm measured by echocardiogram at baseline.
  25. Patients on chronic (or chronic intermittent) IV inotropic medication. -
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
165 participants (estimated)

Study arms

  • Experimental
    1

    myoblast

    Biological: myoblast

  • Sham comparator
    2

    sham injection procedure

    Biological: sham

Interventions

  • Biologicalmyoblast

    autologous myoblast

  • Biologicalsham

    sham injection procedure

06

What researchers measure

Primary outcomes

  1. Kansas City Cardiomyopathy Questionnaire

    Time frame: 6 months

Secondary outcomes

  1. Cardiovascular mortality

    Time frame: 12 months

07

Study locations

1 site
  • Mercy Gilbert
    Gilbert, Arizona 85297, United States
    • NABIL DIB, MD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 29, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00626314
Lead sponsor
Mytogen, Inc.
First posted
Feb 29, 2008
Start date
Mar 2008
Primary completion
Mar 2010 (estimated)
Completion
Aug 2010 (estimated)
Last update
Feb 29, 2008

Study contacts

JEROMY BROWN
Contact
JBrown@ccstrials.com
617-423-7999 ext. 124
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.

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