NCT01216995

Brief Summary

Double blind, prospective, randomized, placebo-controlled Safety and Efficacy trial of ADRCs delivered via the intracoronary route in the treatment of patients with ST-elevation acute myocardial infarction (STEMI).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2012

Geographic Reach
2 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

First Submitted

Initial submission to the registry

October 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2010

Completed
1.9 years until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

November 21, 2014

Status Verified

November 1, 2014

Enrollment Period

1.7 years

First QC Date

October 6, 2010

Last Update Submit

November 19, 2014

Conditions

Acute Myocardial Infarction

Keywords

Heart AttackRegenerative CellsStem Cells

Outcome Measures

Primary Outcomes (1)

  • Reduction in Infarct Size

    Reduction in infarct size at 6 months as measured by cardiac MRI

    6 Months

Secondary Outcomes (1)

  • MACCE Rates

    Through 36 months

Study Arms (2)

Dose A

ACTIVE COMPARATOR

Dose A

Biological: Dose A

Placebo

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Interventions

Dose ABIOLOGICAL

ADRC Dose A

Also known as: Adipose-Derived Regenerative Cells
Dose A
PlaceboBIOLOGICAL

Placebo Comparator

Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ST-segment Elevation Myocardial Infarction (STEMI) Criteria:
  • Ischemic symptoms AND
  • ECG:
  • Development of pathologic Q waves on the ECG; or
  • ECG changes indicative of severe ischemia (ST segment elevation and/or depression); or
  • New left bundle branch block; AND
  • Creatine Phosphokinase Isoenzyme (MB Form) \> 100 IU/L, or troponin \>5x the upper limit of normal between admission and randomization
  • Successful revascularization of the culprit lesion in a major epicardial vessel

You may not qualify if:

  • More than 24 hours between PCI and start of liposuction
  • Prior myocardial infarction, cardiomyopathy, or a history of congestive heart failure
  • Pacemaker, ICD, or any other contra-indication for MRI
  • Patients with increased bleeding risk
  • Cardiogenic shock present post-index PCI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Erasmus University Medical Centrum

Rotterdam, Netherlands

Location

Krakowski Szpital Specjalistyczny im. Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn

Krakow, 31202, Poland

Location

Szpital Uniwersytecki Samodzielna Pracownia Zakladu Hemodynamiki

Krakow, 31501, Poland

Location

Samodzielny Publiczny Centralny Szpital Kliniczny Pracownia Kardiologii Inwazyjnej

Warsaw, 02097, Poland

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Steven Kesten, MD

    Cytori Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
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

October 6, 2010

First Posted

October 8, 2010

Study Start

September 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

November 21, 2014

Record last verified: 2014-11

Locations

PL(3)NL(1)