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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Leg Ulcer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Skin graft pellet

This group concerns patients who are recruited for skin graft procedure leading to the collection of supernumerary biopsies.

Group Type EXPERIMENTAL

Collection of supernumerary biopsies during skin graft pellet procedure

Intervention Type PROCEDURE

Interventions

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Collection of supernumerary biopsies during skin graft pellet procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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