Study to Assess the Efficacy and Safety of Transplanting Autologous Skeletal Myoblasts, Into Infarcted Heart, Using an Catheter Delivery System
NCT ID: NCT00626314
Last Updated: 2008-02-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
165 participants
INTERVENTIONAL
2008-03-31
2010-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
myoblast
myoblast
autologous myoblast
2
sham injection procedure
sham
sham injection procedure
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
myoblast
autologous myoblast
sham
sham injection procedure
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. New York Heart Association Classification III - ambulatory Class IV
3. Ejection fraction \< 35% as determined by any method at baseline evaluation
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
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. -
21 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mytogen, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
MYTOGEN/ADVANCED CELL TECHNOLOGY
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mercy Gilbert
Gilbert, Arizona, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EDAM06-5
Identifier Type: -
Identifier Source: org_study_id