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Safety & Efficacy of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA II)

NCT02052427 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2016-10-28

No results posted yet for this study

Summary

This is a prospective, randomized, placebo-controlled, double blind safety and efficacy clinical trial.

Conditions

  • Myocardial Ischemia

Interventions

DEVICE

Celution System

ADRCs processed by the Celution System for reintroduction into the myocardium

DEVICE

Placebo

Physiological solution made of Lactated Ringers solution and a small amount (\<1mL) of autologous blood

Sponsors & Collaborators

  • Cytori Therapeutics

    lead INDUSTRY

Principal Investigators

  • Emerson C. Perin, MD, PhD · The Stem Cell Center at Texas Heart Institute

  • Timothy Henry, MD · Cedars-Sinai Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-08-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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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 NCT02052427 on ClinicalTrials.gov