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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skin graft pellet | Experimental | This group concerns patients who are recruited for skin graft procedure leading to the collection of supernumerary biopsies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of supernumerary biopsies during skin graft pellet procedure | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of skin substitute reconstructed with cells isolated from patient biopsies | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe Humbert, MD, PhD | Contact | phumbert@chu-besancon.fr | ||
| Gwenael Rolin, PhD | Contact | 0033381219164 | grolin@chu-besancon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Philippe Humbert, MD PhD | University Hospital of BesanƧon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de BesanƧon | Recruiting | BesanƧon | 25000 | France |
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| ID | Term |
|---|---|
| D007871 | Leg Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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