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

Centre Hospitalier Universitaire de Besancon7 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Leg Ulcer

Interventions

Collection of supernumerary biopsies during skin graft pellet procedure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with chronic leg ulcers evolving for more than 6 months * Patient to receive skin pellet transplant * Chronic wound area between 10 and 30 cm² Exclusion Criteria: * Patient without health insurance, * Pregnant womens, * Smoking patient, * Chronic wound area \>30 cm²

Central Contacts

Philippe Humbert, MD, PhD

CONTACT

phumbert@chu-besancon.fr

Gwenael Rolin, PhD

CONTACT

0033381219164 grolin@chu-besancon.fr

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts