Clinical Feasibility of an Advanced Therapy Medicinal Product (ATMP) Preparation for Autologous Skin Regeneration in Case of Chronic Leg Ulcers
Not Applicable
- Conditions
- Leg Ulcer
- Interventions
- Procedure: Collection of supernumerary biopsies during skin graft pellet procedure
- Registration Number
- NCT02842502
- Lead Sponsor
- Centre Hospitalier Universitaire de Besancon
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 7
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Skin graft pellet Collection of supernumerary biopsies during skin graft pellet procedure This group concerns patients who are recruited for skin graft procedure leading to the collection of supernumerary biopsies.
- Primary Outcome Measures
Name Time Method Number of skin substitute reconstructed with cells isolated from patient biopsies 1 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHRU de Besançon
🇫🇷Besançon, France