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Autologous Adipose-Derived Stromal Cell Delivered Via Intramuscular Injections for the Treatment of Critical Limb Ischemia

NCT02099500 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-07-21

No results posted yet for this study

Summary

This is an open-label, non-randomized, multi center, patient sponsored study of Adipose-Derived Stromal Cell (ASC) implantation via intramuscular injections in patients who have critical limb ischemia not amenable for revascularization.

The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed critical limb ischemia ASCs will be collected from the patient's adipose-derived tissue (body fat). Using local anesthesia, Liposuction will be performed to collect the adipose tissue specimen. The adipose tissue is then transferred to the laboratory for separation of the adipose tissue derived stem cells. In addition, peripheral blood will be collected for isolation of platelet rich plasma, which are then combined with the ASC's for intramuscular injection into the lower limb.

Conditions

  • Critical Limb Ischemia

Interventions

PROCEDURE

Liposuction

Liposuction using aspiration syringe and tumescent local anesthesia

OTHER

Stem Cell Injection

Stem cell implantation will be performed using intramuscular injection into the affected ischemic site of interest

Sponsors & Collaborators

  • Ageless Regenerative Institute

    lead INDUSTRY

Principal Investigators

  • Sharon McQuillan, MD · Ageless Regenerative Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-04-30
Completion
2017-06-30

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 NCT02099500 on ClinicalTrials.gov