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Healing Chronic Venous Stasis Wounds With Autologous Cell Therapy

NCT02961699 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-07-28

No results posted yet for this study

Summary

This is a prospective, randomized, single-site, safety and efficacy study of subjects with chronic venous stasis ulcers. Patients will fall into two categories: treatment arm (24 subjects) and non-treatment or control arm (12 subjects). The treatment group will undergo a small liposuction procedure and receive placement of autologous cell therapy (stromal vascular fraction or SVF) injected around the rim of venous stasis wound (subcutaneously)following standard wound debridement, with saturation of collagen dressing material with standard over-dressing. Control (non-treatment) subjects will receive debridement and dressing changes as per standard of care without SVF.

Conditions

  • Wound, Nonpenetrating

Interventions

DEVICE

Transpose ® RT System

adipose-derived stem cell therapy

OTHER

debridement/dressing of wound

standard of care debridement and wound dressing

Sponsors & Collaborators

  • InGeneron, Inc.

    lead INDUSTRY

Principal Investigators

  • Bradley K Coots, M.D. · Sanford Plastic and Reconstructive Surgery- Sioux Falls, SD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2021-10-31
Completion
2022-01-31
FDA Device
Yes

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 NCT02961699 on ClinicalTrials.gov