Clinical Application of Autologous Three-Cellular Cultured Skin Substitutes (CSS)

Study Overview
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Brief Summary
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The aim of this work was to present the investigators experience in the use of autologous three-cellular cultured skin substitutes (CSS) consisting of cultured keratinocytes, melanocytes and fibroblasts attached to a scaffold of hyaluronic acid. This method represents a surgical alternative in the treatment of a variety of pathologies, including burns, ulcers and giant nevi.

Detailed Description
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Background and Objective: Permanent wound closure remains a limiting factor in the closure of extensive, full-thickness loss of substance. The aim of this work was to present our experience in the use of autologous three-cellular cultured skin substitutes (CSS) consisting of cultured keratinocytes, melanocytes and fibroblasts attached to a scaffold of hyaluronic acid. This method represents a surgical alternative in the treatment of a variety of pathologies, including burns, ulcers and giant nevi. Methods: CSS were obtained from full-thickness skin biopsies collected after enrollment of 11 patients in a study protocol approved by the local Institutional Review Boards of the La Sapienza University of Rome. CSS consisted of a structure characterized by the presence of a pluristratified epithelial cell surface with melanocytes (relation 1/20) and a basement of fibroblasts kept together by an esterified hyaluronic acid scaffold that can be surgically manipulated, and is gradually reabsorbed after implantation and substituted by the host connectival stroma.

Official Title
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Clinical Application of Autologous Three-Cellular Cultured Skin Substitutes (CSS) Based on Esterified Hyaluronic Acid Scaffold: Our Experience

Conditions
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Burns, Ulcers, Giant Nevi

Intervention / Treatment
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* Procedure: CSS grafting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: of extensive full-thickness loss of substance Exclusion Criteria: location: face all contra indications for surgery coagulation disorders infection allergic reactions collagenopathies malignant cancer and chemotherapy immunodeficiencies diabetes

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: B<br>the investigators grafted sheets based on the HYAFF11p80® scaffold (the one with the lowest degree of esterification) | Procedure: CSS grafting<br>* grafting of autologous three-cellular cultured skin substitutes (CSS) consisting of cultured keratinocytes, melanocytes and fibroblasts attached to a scaffold of hyaluronic acid (HYAFF11® and HYAFF11p80®) obtained from full-thickness skin biopsies to repair full-thickness loss of substance<br>|
| Other: A<br>the investigators grafted sheets based on the HYAFF11® scaffold (the one with the highest degree of esterification). | Procedure: CSS grafting<br>* grafting of autologous three-cellular cultured skin substitutes (CSS) consisting of cultured keratinocytes, melanocytes and fibroblasts attached to a scaffold of hyaluronic acid (HYAFF11® and HYAFF11p80®) obtained from full-thickness skin biopsies to repair full-thickness loss of substance<br>|
| Other: A-B<br>the investigators grafted sheets based on the HYAFF11® scaffold and sheets based on the HYAFF11p80 ® scaffold | Procedure: CSS grafting<br>* grafting of autologous three-cellular cultured skin substitutes (CSS) consisting of cultured keratinocytes, melanocytes and fibroblasts attached to a scaffold of hyaluronic acid (HYAFF11® and HYAFF11p80®) obtained from full-thickness skin biopsies to repair full-thickness loss of substance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSS graft take compare to the take of autografts confirmed by histological and macroscopic appearance |  | 3 years maximum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final aesthetic outcome determined by the take of melanocytes |  | 3 years maximum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioengineered, ski, keratinocytes, fibroblasts, skin, culture, autologous, CSS, full-thickness loss of substance from:, burns, ulcers, giant nevi, cicatricial outcomes