NCT00426868

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_1

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2007

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

August 28, 2013

Status Verified

August 1, 2013

Enrollment Period

5.2 years

First QC Date

January 23, 2007

Last Update Submit

August 27, 2013

Conditions

Ischemic Heart DiseaseCoronary ArteriosclerosisCardiovascular DiseaseCoronary DiseaseCoronary Artery Disease

Keywords

ADRCStem Cellschronic ischemiaheart diseasecoronary artery diseaseinducible reversible ischemia

Outcome Measures

Primary Outcomes (1)

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

    Up to 36 months

Secondary Outcomes (1)

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

    Up to 36 months

Study Arms (2)

Treatment

EXPERIMENTAL
Other: Direct injection of ADRCs into the Left Ventricle

Placebo

PLACEBO COMPARATOR
Other: Direct injection of placebo into the Left Ventricle

Interventions

Direct injection of ADRCs into the Left VentricleOTHER

Dose escalation

Treatment
Direct injection of placebo into the Left VentricleOTHER
Placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Rigshospitalet University Hospital

Copenhagen, Denmark

Location

Erasmus University Medical Centrum, Thorax Center

Rotterdam, Netherlands

Location

University of Utrecht Medical Center

Utrecht, Netherlands

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Related Publications (1)

  • 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.

    PMID: 24952864DERIVED

MeSH Terms

Conditions

Myocardial IschemiaCoronary Artery DiseaseCardiovascular DiseasesCoronary DiseaseHeart Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2007

First Posted

January 25, 2007

Study Start

January 1, 2007

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

August 28, 2013

Record last verified: 2013-08

Locations

DK(1)ES(1)NL(2)