Autologous Cell Therapy for Ischemic Heart Failure
A Prospective, Multicenter, Feasibility Study of Autologous Muscle-derived Cell (AMDC) Transplantation for Treatment of Advanced Ischemic Heart Failure
1 other identifier
interventional
9
1 country
2
Brief Summary
The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle-derived Cells (AMDC; a preparation of a patient's own cells) as a treatment for patients with advanced heart failure caused by ischemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2011
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 5, 2011
CompletedFirst Submitted
Initial submission to the registry
May 12, 2011
CompletedFirst Posted
Study publicly available on registry
May 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJuly 1, 2021
June 1, 2021
1.9 years
May 12, 2011
June 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of major adverse events associated with the use of AMDC
12 Months
Study Arms (1)
AMDC
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Age greater than 18 but less than 80 years
- Prior myocardial infarction
- Depressed left ventricular ejection fraction (LVEF) ≤ 35%
- NYHA functional classification of II to IV
You may not qualify if:
- Not under stable optimal medical management
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cook MyoSitelead
Study Sites (2)
University of Alberta and Mazankowski Alberta Heart Institute
Edmonton, Alberta, T6G 2B7, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hung Q. Ly, MD
Montreal Heart Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2011
First Posted
May 16, 2011
Study Start
February 5, 2011
Primary Completion
December 12, 2012
Study Completion
June 1, 2014
Last Updated
July 1, 2021
Record last verified: 2021-06