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

August 27, 2013 updated by: Cytori Therapeutics

A Randomized Clinical Trial of adiPose-deRived stEm & Regenerative Cells In the Treatment of Patients With Non revaScularizable ischEmic Myocardium - The PRECISE Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet University Hospital
  • Netherlands
      • Rotterdam, Netherlands
        • Erasmus University Medical Centrum, Thorax Center
      • Utrecht, Netherlands
        • University of Utrecht Medical Center
  • Spain
      • Madrid, Spain
        • Hospital General Universitario Gregorio Marañon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key 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).

Key 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Direct injection of placebo into the Left Ventricle
Experimental: Treatment
Other: Direct injection of ADRCs into the Left Ventricle
Dose escalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)
Time Frame: Up to 36 months
Up to 36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Feasibility - Assessment of cardiac function using a variety of functional and imaging studies including MRI, SPECT and Echocardiography
Time Frame: Up to 36 months
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cytori Therapeutics

Investigators

  • Study Director: Alexander M Milstein, MD, Cytori Therapeutics, Inc
  • Principal Investigator: Francisco J Fernández-Avilés, MD, PhD, FACC, FESC, Hospital G.U. Gregorio Marañón
  • Principal Investigator: Emerson C Perin, MD, PhD, Texas Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

January 23, 2007

First Submitted That Met QC Criteria

January 24, 2007

First Posted (Estimate)

January 25, 2007

Study Record Updates

Last Update Posted (Estimate)

August 28, 2013

Last Update Submitted That Met QC Criteria

August 27, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRECISE-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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