MedTrace Logo

Evaluation of the Tissue Genesis® Icellator Cell Isolation System™ to Treat Critical Limb Ischemia

NCT02234778 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-06-24

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and effectiveness of the Tissue Genesis® Icellator Cell Isolation System™ in Critical Limb Ischemia. The Icellator System™ device removes certain cells from the adipose (fat) tissue which will be used to treat patients with blockages in the arteries of their lower legs that may require a future amputation, which is caused by severe peripheral artery disease (PAD). The purpose of this study is to determine if treatment with cells that have been removed from the Icellator System™ device will reduce the number of major amputations and deaths in a six month time period.

Conditions

  • Critical Limb Ischemia

Interventions

DEVICE

TGI SVF material via intramuscular injection

Each SVF-treated subject will receive up to 30 cc of the TGI SVF material via intramuscular injection (injections at multiple locations on the lower leg - up to 20 total injections) through a 23 gauge needle over a 2- to 4- minute period.

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • Tissue Genesis

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2022-10-31
Completion
2023-10-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT02234778 on ClinicalTrials.gov