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Clinical Trials/NCT02842502
NCT02842502
Unknown
Not Applicable

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

Centre Hospitalier Universitaire de Besancon1 site in 1 country7 target enrollmentSeptember 2014
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ConditionsLeg Ulcer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Leg Ulcer
Sponsor
Centre Hospitalier Universitaire de Besancon
Enrollment
7
Locations
1
Primary Endpoint
Number of skin substitute reconstructed with cells isolated from patient biopsies
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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).

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
September 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Number of skin substitute reconstructed with cells isolated from patient biopsies

Time Frame: 1 year

Study Sites (1)

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