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A Randomized Clinical Trial of Adipose-derived Stem Cells in Treatment of Non Revascularizable Ischemic Myocardium

NCT ID: NCT00426868

Last Updated: 2013-08-28

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to establish safety and feasibility of utilizing Adipose Derived Stem \& Regenerative Cells (ADRCs) in patients who have areas of myocardium that are not revascularizable and have demonstrated reversible ischemia.

Detailed Description

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Subjects who have coronary artery disease that cannot be revascularized and demonstrate reversible ischemia in the area supplied by the non-revascularizable vessel(s) will be evaluated for eligibility in this study. Eligible subjects will undergo standard pre-operative testing after admission to the hospital, and then will undergo liposuction under anesthesia, after which ADRCs will be isolated from the lipoaspirate. According to randomization subjects will receive either ADRCs or placebo.

The outcomes of this trial will be based on assessment of primary and secondary endpoints at 6 months post index procedure. Long Term Follow-up will be conducted at 12, 18, 24 and 36 months after the procedure.

Conditions

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Ischemic Heart Disease Coronary Arteriosclerosis Cardiovascular Disease Coronary Disease Coronary Artery Disease

Keywords

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ADRC Stem Cells chronic ischemia heart disease coronary artery disease inducible reversible ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment

Group Type EXPERIMENTAL

Direct injection of ADRCs into the Left Ventricle

Intervention Type OTHER

Dose escalation

Placebo

Group Type PLACEBO_COMPARATOR

Direct injection of placebo into the Left Ventricle

Intervention Type OTHER

Interventions

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Direct injection of ADRCs into the Left Ventricle

Dose escalation

Intervention Type OTHER

Direct injection of placebo into the Left Ventricle

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Able to provide written informed consent
* Males or females 20 to 75 years of age, inclusive
* Coronary artery disease not amenable to any type of revascularization procedure (percutaneous or surgical) in the target area
* Hemodynamic stability
* Ability to undergo liposuction
* Ability to walk on a treadmill
* Negative urine pregnancy test (females only).

Exclusion Criteria

* Unstable angina
* Serum creatinine \>2.5 mg/dL
* Planned or scheduled staged treatment of CAD or other interventional or surgical procedures
* Cardiogenic shock
* History of resuscitated sudden cardiac death; or symptomatic or sustained ventricular fibrillation or ventricular tachycardia.
* Vascular anatomy that precludes cardiac catheterization
* Peripheral artery disease that precludes insertion of an 8 Fr sheath
* Severe valvular disease
* Pregnant or nursing females
* Known and relevant allergies or sensitivities
* Life expectancy \<1 year
* Participation in any other clinical research study that has not reached its primary endpoint or otherwise would interfere with the subject's participation in this study
* Any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cytori Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander M Milstein, MD

Role: STUDY_DIRECTOR

Cytori Therapeutics, Inc

Francisco J Fernández-Avilés, MD, PhD, FACC, FESC

Role: PRINCIPAL_INVESTIGATOR

Hospital G.U. Gregorio Marañón

Emerson C Perin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Heart Institute

Locations

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Rigshospitalet University Hospital

Copenhagen, , Denmark

Site Status

Erasmus University Medical Centrum, Thorax Center

Rotterdam, , Netherlands

Site Status

University of Utrecht Medical Center

Utrecht, , Netherlands

Site Status

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Site Status

Countries

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Denmark Netherlands Spain

References

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Perin EC, Sanz-Ruiz R, Sanchez PL, Lasso J, Perez-Cano R, Alonso-Farto JC, Perez-David E, Fernandez-Santos ME, Serruys PW, Duckers HJ, Kastrup J, Chamuleau S, Zheng Y, Silva GV, Willerson JT, Fernandez-Aviles F. Adipose-derived regenerative cells in patients with ischemic cardiomyopathy: The PRECISE Trial. Am Heart J. 2014 Jul;168(1):88-95.e2. doi: 10.1016/j.ahj.2014.03.022. Epub 2014 Apr 5.

Reference Type DERIVED
PMID: 24952864 (View on PubMed)

Other Identifiers

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PRECISE-01

Identifier Type: -

Identifier Source: org_study_id