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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02842502

Acronym

MecaSkin

Enrollment

Registered

2016-07-25

Start date

2014-09-30

Completion date

2018-09-30

Last updated

2016-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leg Ulcer

Keywords

Skin Substitutes

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).

Interventions

PROCEDURECollection of supernumerary biopsies during skin graft pellet procedure

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Number of skin substitute reconstructed with cells isolated from patient biopsies	1 year

Countries

France

Contacts

Primary ContactPhilippe Humbert, MD, PhD

phumbert@chu-besancon.fr

Backup ContactGwenael Rolin, PhD

grolin@chu-besancon.fr0033381219164

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026