Autologous Cell Therapy for Ischemic Heart Failure
This study is currently recruiting participants.
Verified March 2013 by Cook
Sponsor:
Cook MyoSite
Information provided by (Responsible Party):
Cook ( Cook MyoSite )
ClinicalTrials.gov Identifier:
NCT01353690
First received: May 12, 2011
Last updated: March 19, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ischemic Heart Disease |
Biological: AMDC |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Multicenter, Feasibility Study of Autologous Muscle-derived Cell (AMDC) Transplantation for Treatment of Advanced Ischemic Heart Failure |
Resource links provided by NLM:
Further study details as provided by Cook:
Primary Outcome Measures:
- Incidence of major adverse events associated with the use of AMDC [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 20 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AMDC |
Biological: AMDC
Cell Treatment
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353690
Contacts
| Contact: Chris Ballas | 765-463-7537 | cballas@medinst.com |
Locations
| Canada, Alberta | |
| University of Alberta and Mazankowski Alberta Heart Institute | Recruiting |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Contact: Robert Welsh, MD 780-407-3613 | |
| Canada, Quebec | |
| Montreal Heart Institute | Recruiting |
| Montreal, Quebec, Canada, H1T 1C8 | |
| Contact: Nathalie St-Jean, RN 514-376-3330 nathalie.st-jean@icm-mhi.org | |
Sponsors and Collaborators
Cook MyoSite
Investigators
| Principal Investigator: | Hung Q. Ly, MD | Montreal Heart Institute |
More Information
No publications provided
| Responsible Party: | Cook ( Cook MyoSite ) |
| ClinicalTrials.gov Identifier: | NCT01353690 History of Changes |
| Other Study ID Numbers: | 10-013 |
| Study First Received: | May 12, 2011 |
| Last Updated: | March 19, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Cook:
|
Cell Therapy Heart Failure Heart Disease Myocardial Infarction |
Myocardial Ischemia Autologous Muscle-derived Cell |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Heart Diseases Heart Failure Ischemia Coronary Disease |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013