NCT02961699

Healing Chronic Venous Stasis Wounds With Autologous Cell Therapy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: InGeneron, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Transpose ® RT System	adipose-derived stem cell therapy
OTHER	debridement/dressing of wound	standard of care debridement and wound dressing

Timeline

• Start date: 2017-06-01
• Primary completion: 2021-10-01
• Completion: 2022-01-01
• First posted: 2016-11-11
• Last updated: 2020-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study