Autologous Cell Therapy for Ischemic Heart Failure

Phase 1

Terminated

• Conditions: Ischemic Heart Disease
• Interventions: Biological: AMDC

• Registration Number: NCT01353690
• Lead Sponsor: Cook MyoSite

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-05
• Study First Submitted: 2011-05-12
• Study First Submitted QC: 2011-05-12
• Study First Posted: 2011-05-16
• Primary Completion: 2012-12-12
• Study Completion: 2014-06
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-29
• Last Update Posted: 2021-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMDC	AMDC	-

Primary Outcome Measures

Name	Time	Method
Incidence of major adverse events associated with the use of AMDC	12 Months

Trial Locations

Locations (2)

University of Alberta and Mazankowski Alberta Heart Institute; 🇨🇦 Edmonton, Alberta, Canada

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada