- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00626314
Study to Assess the Efficacy and Safety of Transplanting Autologous Skeletal Myoblasts, Into Infarcted Heart, Using an Catheter Delivery System (CAuSMIc II)
February 28, 2008 updated by: Mytogen, Inc.
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
165
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: JEROMY BROWN
- Phone Number: 124 617-423-7999
- Email: JBrown@ccstrials.com
Study Locations
-
-
Arizona
-
Gilbert, Arizona, United States, 85297
- Mercy Gilbert
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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).
- 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.
Exclusion Criteria:
- 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.
- Subjects who have received a prior investigational stem cell or angiogenic agent.
- Subjects who have tested positive for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and/or Hepatitis C Virus (HCV).
- 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.
- Creatine phosphokinase (CK) or lactate dehydrogenase elevated greater than three times normal or unexplained elevations of CK.
- 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.
- 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).
- 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.
- Idiopathic Cardiomyopathy, hypertrophic cardiomyopathy
- Subjects with ventricular wall thickness in the infarct zone of < 5 mm measured by echocardiogram at baseline.
- Patients on chronic (or chronic intermittent) IV inotropic medication. -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
myoblast
|
autologous myoblast
|
SHAM_COMPARATOR: 2
sham injection procedure
|
sham injection procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Kansas City Cardiomyopathy Questionnaire
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cardiovascular mortality
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (ANTICIPATED)
March 1, 2010
Study Completion (ANTICIPATED)
August 1, 2010
Study Registration Dates
First Submitted
February 21, 2008
First Submitted That Met QC Criteria
February 28, 2008
First Posted (ESTIMATE)
February 29, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
February 29, 2008
Last Update Submitted That Met QC Criteria
February 28, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EDAM06-5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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