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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Mytogen, Inc..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Mytogen, Inc.
ClinicalTrials.gov Identifier:
NCT00626314
First received: February 21, 2008
Last updated: February 28, 2008
Last verified: February 2008

February 21, 2008
February 28, 2008
March 2008
March 2010   (final data collection date for primary outcome measure)
Kansas City Cardiomyopathy Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00626314 on ClinicalTrials.gov Archive Site
Cardiovascular mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Assess the Efficacy and Safety of Transplanting Autologous Skeletal Myoblasts, Into Infarcted Heart, Using an Catheter Delivery System
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Trial to Assess the Efficacy, Safety and Tolerability of Transplanting Autologous Skeletal Myoblasts, Into Infarcted Myocardium, Using an Endomyocardial Delivery System

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Ischemic Cardiomyopathy
  • Biological: myoblast
    autologous myoblast
  • Biological: sham
    sham injection procedure
  • Experimental: 1
    myoblast
    Intervention: Biological: myoblast
  • Sham Comparator: 2
    sham injection procedure
    Intervention: Biological: sham
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
165
August 2010
March 2010   (final data collection date for primary outcome measure)

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:

  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. -
Both
21 Years to 75 Years
No
Contact: JEROMY BROWN 617-423-7999 ext 124 JBrown@ccstrials.com
United States
 
NCT00626314
EDAM06-5
Not Provided
JONATHAN DINSMORE, PHD/SENIOR VICE PRESIDENT, CLINICAL&REGULATORY AFFAIRS, MYTOGEN/ADVANCED CELL TECHNOLOGY
Mytogen, Inc.
Not Provided
Not Provided
Mytogen, Inc.
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP