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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02842502
Recruitment Status : Unknown
Verified July 2016 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Recruiting
First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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).

Condition or disease Intervention/treatment Phase
Leg Ulcer Procedure: Collection of supernumerary biopsies during skin graft pellet procedure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Clinical Feasibility of an Advanced Therapy Medicinal Product (ATMP) Preparation for Autologous Skin Regeneration in Patients Carriers of Leg Ulcers
Study Start Date : September 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Skin graft pellet
This group concerns patients who are recruited for skin graft procedure leading to the collection of supernumerary biopsies.
Procedure: Collection of supernumerary biopsies during skin graft pellet procedure



Primary Outcome Measures :
  1. Number of skin substitute reconstructed with cells isolated from patient biopsies [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842502


Contacts
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Contact: Philippe Humbert, MD, PhD phumbert@chu-besancon.fr
Contact: Gwenael Rolin, PhD 0033381219164 grolin@chu-besancon.fr

Locations
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France
CHRU de Besançon Recruiting
Besançon, France, 25000
Contact: Philippe Humbert, MD, PhD       phumbert@chu-besancon.fr   
Contact: Gwenaël Rolin, PhD    0033381219164    grolin@chu-besancon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Philippe Humbert, MD PhD University Hospital of Besançon
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02842502    
Other Study ID Numbers: API/2012/33
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Skin Substitutes
Additional relevant MeSH terms:
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Leg Ulcer
Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases