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

Primary Purpose

Ischemic Heart Disease, Coronary Arteriosclerosis, Cardiovascular Disease

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Direct injection of ADRCs into the Left Ventricle

Direct injection of placebo into the Left Ventricle

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring ADRC, Stem Cells, chronic ischemia, heart disease, coronary artery disease, inducible reversible ischemia

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rigshospitalet University Hospital
Erasmus University Medical Centrum, Thorax Center
University of Utrecht Medical Center
Hospital General Universitario Gregorio Marañón

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)

Secondary Outcome Measures

Feasibility - Assessment of cardiac function using a variety of functional and imaging studies including MRI, SPECT and Echocardiography

Full Information

NCT ID

NCT00426868

First Posted

January 23, 2007

Last Updated

August 27, 2013

Sponsor

Cytori Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT00426868

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cytori Therapeutics

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

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

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Other

Intervention Name(s)

Direct injection of ADRCs into the Left Ventricle

Intervention Description

Dose escalation

Intervention Type

Other

Intervention Name(s)

Direct injection of placebo into the Left Ventricle

Primary Outcome Measure Information:

Title

Safety - Determined by Major Adverse Cardiac and Cerebral Events (MACCE)

Time Frame

Up to 36 months

Secondary Outcome Measure Information:

Title

Feasibility - Assessment of cardiac function using a variety of functional and imaging studies including MRI, SPECT and Echocardiography

Time Frame

Up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander M Milstein, MD

Organizational Affiliation

Cytori Therapeutics, Inc

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Hospital G.U. Gregorio Marañón

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Emerson C Perin, MD, PhD

Organizational Affiliation

Texas Heart Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rigshospitalet University Hospital

City

Copenhagen

Country

Denmark

Facility Name

Erasmus University Medical Centrum, Thorax Center

City

Rotterdam

Country

Netherlands

Facility Name

University of Utrecht Medical Center

City

Utrecht

Country

Netherlands

Facility Name

Hospital General Universitario Gregorio Marañón

City

Madrid

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

24952864

Citation

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.

Results Reference

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

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