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Autologous Cell Therapy for Ischemic Heart Failure

Primary Purpose

Ischemic Heart Disease

Status

Terminated

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

AMDC

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Cell Therapy, Heart Failure, Heart Disease, Myocardial Infarction, Myocardial Ischemia, Autologous, Muscle-derived Cell

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Alberta and Mazankowski Alberta Heart Institute
Montreal Heart Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AMDC

Arm Description

Outcomes

Primary Outcome Measures

Incidence of major adverse events associated with the use of AMDC

Secondary Outcome Measures

Full Information

NCT ID

NCT01353690

First Posted

May 12, 2011

Last Updated

June 29, 2021

Sponsor

Cook MyoSite

1. Study Identification

Unique Protocol Identification Number

NCT01353690

Brief Title

Autologous Cell Therapy for Ischemic Heart Failure

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Terminated

Study Start Date

February 5, 2011 (Actual)

Primary Completion Date

December 12, 2012 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cook MyoSite

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Heart Disease

Keywords

Cell Therapy, Heart Failure, Heart Disease, Myocardial Infarction, Myocardial Ischemia, Autologous, Muscle-derived Cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AMDC

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

AMDC

Intervention Description

Cell Treatment

Primary Outcome Measure Information:

Title

Incidence of major adverse events associated with the use of AMDC

Time Frame

12 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hung Q. Ly, MD

Organizational Affiliation

Montreal Heart Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alberta and Mazankowski Alberta Heart Institute

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

Montreal Heart Institute

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 1C8

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Autologous Cell Therapy for Ischemic Heart Failure

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