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

NCT00426868 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2013-08-28

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Direct injection of ADRCs into the Left Ventricle

Dose escalation

OTHER

Direct injection of placebo into the Left Ventricle

Sponsors & Collaborators

  • Cytori Therapeutics

    lead INDUSTRY

Principal Investigators

  • Alexander M Milstein, MD · Cytori Therapeutics, Inc

  • Francisco J Fernández-Avilés, MD, PhD, FACC, FESC · Hospital G.U. Gregorio Marañón

  • Emerson C Perin, MD, PhD · Texas Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Denmark
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00426868 on ClinicalTrials.gov