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

Sponsored by:	University of Roma La Sapienza
Information provided by:	University of Roma La Sapienza
ClinicalTrials.gov Identifier:	NCT00718978

Purpose

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.

Condition	Intervention
Burns Ulcers Giant Nevi	Procedure: CSS grafting

MedlinePlus related topics: Burns Moles

Drug Information available for: Hyaluronate Sodium Hyaluronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Clinical Application of Autologous Three-Cellular Cultured Skin Substitutes (CSS) Based on Esterified Hyaluronic Acid Scaffold: Our Experience

Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:

CSS graft take compare to the take of autografts confirmed by histological and macroscopic appearance [ Time Frame: 3 years maximum ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Final aesthetic outcome determined by the take of melanocytes [ Time Frame: 3 years maximum ] [ Designated as safety issue: No ]

Enrollment:	11
Study Start Date:	June 2003
Study Completion Date:	July 2007
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B the investigators grafted sheets based on the HYAFF11p80® scaffold (the one with the lowest degree of esterification)	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
A the investigators grafted sheets based on the HYAFF11® scaffold (the one with the highest degree of esterification).	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
A-B the investigators grafted sheets based on the HYAFF11® scaffold and sheets based on the HYAFF11p80 ® scaffold	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

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.

Eligibility

Ages Eligible for Study:	1 Year to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718978

Locations

Italy
Dipartimento Malattie Cutanee-Veneree e Chirurgia Plastica e Ricostruttiva universita' "La Sapienza" Roma
roma, Italy, 00161

Sponsors and Collaborators

University of Roma La Sapienza

Investigators

Study Chair:

nicolo' scuderi, professor

universita "la Sapienza" Roma

More Information

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. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2008 Jan 16.

Responsible Party:	Department of plastic and reconstructive Surgery ( nicolo' scuderi )
Study ID Numbers:	928/07
Study First Received:	July 18, 2008
Last Updated:	September 5, 2008
ClinicalTrials.gov Identifier:	NCT00718978
Health Authority:	Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:

bioengineered
ski
keratinocytes
fibroblasts
skin
culture
autologous

CSS
full-thickness loss of substance from:
burns
ulcers
giant nevi
cicatricial outcomes

Study placed in the following topic categories:

Burns
Hyaluronic Acid
Ulcer
Nevus, Pigmented
Nevus

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009