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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00718978
Enrollment
11
Registered
2008-07-21
Start date
2003-06-30
Completion date
2007-07-31
Last updated
2008-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns, Giant Nevi, Ulcers

Keywords

bioengineered, ski, keratinocytes, fibroblasts, skin, culture, autologous, CSS, full-thickness loss of substance from:, burns, ulcers, giant nevi, cicatricial outcomes

Brief summary

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

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.

Interventions

PROCEDURECSS grafting

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

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
CSS graft take compare to the take of autografts confirmed by histological and macroscopic appearance3 years maximum

Secondary

MeasureTime frame
Final aesthetic outcome determined by the take of melanocytes3 years maximum

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026