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

NCT02842502 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2016-07-25

No results posted yet for this study

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).

Conditions

  • Leg Ulcer

Interventions

PROCEDURE

Collection of supernumerary biopsies during skin graft pellet procedure

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Principal Investigators

  • Philippe Humbert, MD PhD · University Hospital of Besançon

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-03-31
Completion
2018-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02842502 on ClinicalTrials.gov