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

Centre Hospitalier Universitaire de Besancon

Status: Unknown

Conditions: Leg Ulcer

Treatments: Procedure: Collection of supernumerary biopsies during skin graft pellet procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT02842502

API/2012/33

Details and patient eligibility

About

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).

Enrollment: 7 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Skin graft pellet

Experimental group

Description:

This group concerns patients who are recruited for skin graft procedure leading to the collection of supernumerary biopsies.

Treatment:

Procedure: Collection of supernumerary biopsies during skin graft pellet procedure