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
  Purpose

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.


Condition Intervention Phase
Ischemic Cardiomyopathy
Biological: myoblast
Biological: sham
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Mytogen, Inc.:

Primary Outcome Measures:
  • Kansas City Cardiomyopathy Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 165
Study Start Date: March 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
myoblast
Biological: myoblast
autologous myoblast
Sham Comparator: 2
sham injection procedure
Biological: sham
sham injection procedure

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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626314

Contacts
Contact: JEROMY BROWN 617-423-7999 ext 124 JBrown@ccstrials.com

Locations
United States, Arizona
Mercy Gilbert Not yet recruiting
Gilbert, Arizona, United States, 85297
Principal Investigator: NABIL DIB, MD         
Sponsors and Collaborators
Mytogen, Inc.
  More Information

No publications provided

Responsible Party: JONATHAN DINSMORE, PHD/SENIOR VICE PRESIDENT, CLINICAL&REGULATORY AFFAIRS, MYTOGEN/ADVANCED CELL TECHNOLOGY
ClinicalTrials.gov Identifier: NCT00626314     History of Changes
Other Study ID Numbers: EDAM06-5
Study First Received: February 21, 2008
Last Updated: February 28, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cardiomyopathies
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 28, 2014