- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02842502
Clinical Feasibility of an Advanced Therapy Medicinal Product (ATMP) Preparation for Autologous Skin Regeneration in Case of Chronic Leg Ulcers (MecaSkin)
July 22, 2016 updated by: Centre Hospitalier Universitaire de Besancon
Clinical Feasibility of an Advanced Therapy Medicinal Product (ATMP) Preparation for Autologous Skin Regeneration in Patients Carriers of Leg Ulcers
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gwenaël Rolin, PhD
- Phone Number: 0033381219164
- Email: grolin@chu-besancon.fr
Study Contact Backup
- Name: Philippe Humbert, MD, PhD
- Email: phumbert@chu-besancon.fr
Study Locations
-
-
-
Besançon, France, 25000
- Recruiting
- CHRU de Besançon
-
Contact:
- Gwenaël Rolin, PhD
- Phone Number: 0033381219164
- Email: grolin@chu-besancon.fr
-
Contact:
- Philippe Humbert, MD, PhD
- Email: phumbert@chu-besancon.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of skin substitute reconstructed with cells isolated from patient biopsies
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Philippe Humbert, MD PhD, University Hospital of Besancon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Anticipated)
March 1, 2018
Study Completion (Anticipated)
September 1, 2018
Study Registration Dates
First Submitted
July 18, 2016
First Submitted That Met QC Criteria
July 22, 2016
First Posted (Estimate)
July 25, 2016
Study Record Updates
Last Update Posted (Estimate)
July 25, 2016
Last Update Submitted That Met QC Criteria
July 22, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- API/2012/33
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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