Autologous Cell Therapy for Ischemic Heart Failure

NCT ID: NCT01353690

Last Updated: 2021-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-05

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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Ischemic Heart Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AMDC

Group Type EXPERIMENTAL

AMDC

Intervention Type BIOLOGICAL

Cell Treatment

Interventions

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AMDC

Cell Treatment

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook MyoSite

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hung Q. Ly, MD

Role: PRINCIPAL_INVESTIGATOR

Montreal Heart Institute

Locations

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University of Alberta and Mazankowski Alberta Heart Institute

Edmonton, Alberta, Canada

Site Status

Montreal Heart Institute

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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10-013

Identifier Type: -

Identifier Source: org_study_id

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