Autologous Cell Therapy for Ischemic Heart Failure

Ischemic Heart Disease Clinical Trial

Official title:

A Prospective, Multicenter, Feasibility Study of Autologous Muscle-derived Cell (AMDC) Transplantation for Treatment of Advanced Ischemic Heart Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01353690
• Other study ID #: 10-013
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: February 5, 2011
• Est. completion date: June 2014

Study information

• Verified date: June 2021
• Source: Cook MyoSite
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 2014
• Est. primary completion date: December 12, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Heart Failure
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Biological:
• AMDC
Cell Treatment

Locations

Country	Name	City	State
Canada	University of Alberta and Mazankowski Alberta Heart Institute	Edmonton	Alberta
Canada	Montreal Heart Institute	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Cook MyoSite

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major adverse events associated with the use of AMDC		12 Months