A Randomized Clinical Trial of Adipose-derived Stem Cells... | NCT00426868

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

NCT00426868

Sponsor

Cytori Therapeutics

Status

Completed

Last Update Posted

Aug 28, 2013Estimated

Enrollment

27Actual

Phase

Phase 1

Conditions

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

Interventions

Direct injection of ADRCs into the Left Ventricle
Direct injection of placebo into the Left Ventricle

Countries

Denmark
Netherlands
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Jan 23, 2007

First Submission Date that Met QC Criteria

Jan 24, 2007

First Posted Date

Jan 25, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2013

Last Update Posted Date

Aug 28, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental		Other: Direct injection of ADRCs into the Left Ventricle
Placebo	Placebo Comparator		Other: Direct injection of placebo into the Left Ventricle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Direct injection of ADRCs into the Left Ventricle	Other	Dose escalation	Treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet University Hospital		Copenhagen			Denmark
Erasmus University Medical Centrum, Thorax Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24952864	Derived	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.

ID	Term
D017202	Myocardial Ischemia
D003324	Coronary Artery Disease
D002318	Cardiovascular Diseases
D003327	Coronary Disease
D006331	Heart Diseases

ID	Term
D014652	Vascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases