NCT02842502

Clinical Feasibility of an Advanced Therapy Medicinal Product (ATMP) Preparation for Autologous Skin Regeneration in Case of Chronic Leg Ulcers

Clinical Feasibility of an Advanced Therapy Medicinal Product (ATMP) Preparation for Autologous Skin Regeneration in Patients Carriers of Leg Ulcers

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study deals with the feasibility of an ATMP (Advanced Therapy Medicinal Product) production for the treatment of chronic wounds ulcer. Recruitment concerns patients (n=7) with leg ulcers and receiving a skin pellet graft. During surgical procedure, supernumerary biopsies are planned to be done in order to be transferred to laboratory. Then, the possibility of cell extraction (keratinocytes and fibroblasts), expansion, banking and use for skin substitute production in clinical condition is evaluated (primary outcome).

Conditions

• Leg Ulcer

Interventions

Type	Name	Description
PROCEDURE	Collection of supernumerary biopsies during skin graft pellet procedure

Timeline

• Start date: 2014-09-01
• Primary completion: 2018-03-01
• Completion: 2018-09-01
• First posted: 2016-07-25
• Last updated: 2016-07-25

Locations

1 site across 1 country: France