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
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TERMINATED
PHASE1/PHASE2
9 participants
INTERVENTIONAL
2011-02-05
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AMDC
AMDC
Cell Treatment
Interventions
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AMDC
Cell Treatment
Eligibility Criteria
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Inclusion Criteria
* Prior myocardial infarction
* Depressed left ventricular ejection fraction (LVEF) ≤ 35%
* NYHA functional classification of II to IV
Exclusion Criteria
* Cardiac surgery or percutaneous coronary intervention within 3 months
* Occurrence of myocardial infarction (MI) within 6 months, in the case of first MI, or 3 months, in the case of any subsequent MI
* Prior cell, gene, or transmyocardial laser revascularization therapy
* Ventricular wall thickness in target region ≤ 5 mm
* Moderate to severe aortic valve stenosis or mechanical valve replacement
* Left ventricular aneurysm or thrombus
* Left ventricular dysfunction associated with a reversible cause
* Vascular disease preventing percutaneous vascular access
* History of myopathic disease
* History of neoplasia within 5 years, except for basal cell carcinoma
* Receiving or planning to receive anti-cancer medications
* Serum creatinine \> 3.0 mg/dl
* Pregnant, planning to become pregnant, or breastfeeding a child in the next 18 months
* Life expectancy of less than 1 year
* Morbid obesity (defined as BMI \> 35)
* History of bleeding diathesis or coagulopathy
* Positive for HIV, Hepatitis B, or Hepatitis C
* Known hypersensitivity or contraindication to study product or treatment procedure
* Enrolled in another research project at the time of enrollment
* Unable to provide informed consent
* Unable or unwilling to commit to the follow-up clinical procedures
18 Years
80 Years
ALL
No
Sponsors
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Cook MyoSite
INDUSTRY
Responsible Party
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Principal Investigators
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Hung Q. Ly, MD
Role: PRINCIPAL_INVESTIGATOR
Montreal Heart Institute
Locations
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University of Alberta and Mazankowski Alberta Heart Institute
Edmonton, Alberta, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Countries
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Other Identifiers
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10-013
Identifier Type: -
Identifier Source: org_study_id
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