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NCT02842502 Clinical Trial

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

Leg Ulcer Clinical Trial

— MecaSkin  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02842502
Other study ID # API/2012/33
Secondary ID
Status Recruiting
Phase N/A
First received July 18, 2016
Last updated July 22, 2016
Start date September 2014
Est. completion date September 2018

Study information
Verified date July 2016
Source Centre Hospitalier Universitaire de Besancon
Contact Philippe Humbert, MD, PhD
Email phumbert@chu-besancon.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 7
Est. completion date September 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France CHRU de Besançon Besançon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of skin substitute reconstructed with cells isolated from patient biopsies 1 year No
See also
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