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Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia

NCT01556022 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2016-10-28

No results posted yet for this study

Summary

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

Conditions

  • Myocardial Ischemia

Interventions

DEVICE

ADRCs processed by the Celution System

Subjects will undergo liposuction under anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs. When randomized to ADRCs, intramyocardial injections of ADRCs will be administered via the MYOSTAR injection catheter.

DEVICE

Placebo Comparator: Lactated Ringer's and Subject's Blood

Subjects will undergo liposuction under anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs. When randomized to Placebo, intramyocardial injections of Placebo will be administered via the MYOSTAR injection catheter.

Sponsors & Collaborators

  • Cytori Therapeutics

    lead INDUSTRY

Principal Investigators

  • Emerson Perin, MD, PhD · Texas Heart Institute, Houston, TX

  • Timothy Henry, MD · Minneapolis Heart Institute Foundation, Minneapolis, MN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-06-30
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 NCT01556022 on ClinicalTrials.gov