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

NCT00626314 | Unknown Phase 2

• 1 other identifier: EDAM06-5
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Kansas City Cardiomyopathy Questionnaire

  6 months

Secondary Outcomes (1)

• Cardiovascular mortality

  12 months

Study Arms (2)

1

EXPERIMENTAL

myoblast

Biological: myoblast

2

SHAM COMPARATOR

sham injection procedure

Biological: sham

Interventions

myoblast BIOLOGICAL

autologous myoblast

1

sham BIOLOGICAL

sham injection procedure

2

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with ischemic cardiomyopathy and previous myocardial infarction
• New York Heart Association Classification III - ambulatory Class IV
• Ejection fraction \< 35% as determined by any method at baseline evaluation
• Documentation of ineligibility for coronary revascularization and/or valve repair/ replacement by review of recent left heart catheterization (within six months of baseline).
• 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
• Severe myocardial perfusion abnormality documented by SPECT imaging, involving at least 1/3 of a vascular territory, as confirmed by core lab.

You may not qualify if:

• Age \< 21 years or \> 75 years.
• Significant coronary stenosis, as determined by the Investigator, which may potentially require percutaneous or surgical revascularization within 12 weeks of enrollment.
• Recent (within 4 weeks), documented acute coronary syndrome, i.e. (Q wave or non-Q wave infarction) or hospitalization for unstable angina.
• Documented cerebrovascular accident (stroke) or TIA within 60 days.
• Left ventricular thrombus (mobile or mural-based) as evidenced by ventriculogram or echocardiography.
• 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.
• Subjects with CRT placement within three months of enrollment or intent to insert CRT, or CRT settings not judged to be optimized
• High grade atrioventricular block not corrected by permanent pacemaker or ICD.
• Frequent or recurrent, ventricular tachycardia in absence of an ICD.
• Atrial fibrillation with uncontrolled ventricular response
• 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.
• Severe peripheral vascular disease, such that femoral access would be prohibited.
• INR \> 1.5 in absence of coumadin or partial thromboplastin time (PTT) \>20% above ULN, or thrombocytopenia (platelet count \< 75,000).
• 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 \[ULN\]).
• 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.

Sponsors & Collaborators

• Mytogen, Inc.: lead

Study Sites (1)

Mercy Gilbert

Gilbert, Arizona, 85297, United States

Location

MeSH Terms

Interventions

salicylhydroxamic acid

Central Study Contacts

JEROMY BROWN

CONTACT

617-423-7999; JBrown@ccstrials.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 21, 2008
• First Posted: February 29, 2008
• Study Start: March 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: August 1, 2010
• Last Updated: February 29, 2008

Record last verified: 2008-02

Locations

US (1)