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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)

Primary Purpose

Leg Ulcer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Collection of supernumerary biopsies during skin graft pellet procedure
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Leg Ulcer focused on measuring Skin Substitutes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHRU de BesançonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Skin graft pellet

Arm Description

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

Outcomes

Primary Outcome Measures

Number of skin substitute reconstructed with cells isolated from patient biopsies

Secondary Outcome Measures

Full Information

First Posted
July 18, 2016
Last Updated
July 22, 2016
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT02842502
Brief Title
Clinical Feasibility of an Advanced Therapy Medicinal Product (ATMP) Preparation for Autologous Skin Regeneration in Case of Chronic Leg Ulcers
Acronym
MecaSkin
Official Title
Clinical Feasibility of an Advanced Therapy Medicinal Product (ATMP) Preparation for Autologous Skin Regeneration in Patients Carriers of Leg Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Ulcer
Keywords
Skin Substitutes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Skin graft pellet
Arm Type
Experimental
Arm Description
This group concerns patients who are recruited for skin graft procedure leading to the collection of supernumerary biopsies.
Intervention Type
Procedure
Intervention Name(s)
Collection of supernumerary biopsies during skin graft pellet procedure
Primary Outcome Measure Information:
Title
Number of skin substitute reconstructed with cells isolated from patient biopsies
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Humbert, MD, PhD
Email
phumbert@chu-besancon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Gwenael Rolin, PhD
Phone
0033381219164
Email
grolin@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Humbert, MD PhD
Organizational Affiliation
University Hospital of Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Humbert, MD, PhD
Email
phumbert@chu-besancon.fr
First Name & Middle Initial & Last Name & Degree
Gwenaël Rolin, PhD
Phone
0033381219164
Email
grolin@chu-besancon.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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