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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00718978
• Other study ID #: 928/07
• Status: Completed
• Phase: N/A
• First received: July 18, 2008
• Last updated: September 5, 2008
• Start date: June 2003
• Est. completion date: July 2007

Study information

• Verified date: July 2008
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 2007
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Giant Nevi
• Ulcers

Intervention

Procedure:
• CSS 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

Locations

Country	Name	City	State
Italy	Dipartimento Malattie Cutanee-Veneree e Chirurgia Plastica e Ricostruttiva universita' "La Sapienza" Roma	Roma

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Scuderi N, Onesti MG, Bistoni G, Ceccarelli S, Rotolo S, Angeloni A, Marchese C. The clinical application of autologous bioengineered skin based on a hyaluronic acid scaffold. Biomaterials. 2008 Apr;29(11):1620-9. doi: 10.1016/j.biomaterials.2007.12.024. Epub 2008 Jan 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CSS graft take compare to the take of autografts confirmed by histological and macroscopic appearance		3 years maximum	Yes
Secondary	Final aesthetic outcome determined by the take of melanocytes		3 years maximum	No

External Links

•   There is the full manuscript. if you click on "album fotografici" in the upper right column you can see the pictures of the results. the legends are at the end of the text.