Clinical trial NCT00718978: Clinical Application of Autologous Three-Cellular Cultured Skin Substitutes (CSS)
Official title: Clinical Application of Autologous Three-Cellular Cultured Skin Substitutes (CSS) Based on Esterified Hyaluronic Acid Scaffold: Our Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Ulcers
Giant Nevi
Keywords: bioengineered
ski
keratinocytes
fibroblasts
skin
culture
autologous
CSS
full-thickness loss of substance from:
burns
ulcers
giant nevi
cicatricial outcomes
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2008-07-21
Enrollment: 11
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: CSS graft take compare to the take of autografts confirmed by histological and macroscopic appearance
timeFrame: 3 years maximum
Secondary outcomes:
measure: Final aesthetic outcome determined by the take of melanocytes
timeFrame: 3 years maximum
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Dipartimento Malattie Cutanee-Veneree e Chirurgia Plastica e Ricostruttiva universita' "La Sapienza" Roma
Study officials:
affiliation: universita "la Sapienza" Roma
name: nicolo' scuderi, professor
role: STUDY_CHAIR
References:
citation: 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.
citation: Scuderi N, Anniboletti T, Carlesimo B, Onesti MG. Clinical application of autologous three-cellular cultured skin substitutes based on esterified hyaluronic acid scaffold: our experience. In Vivo. 2009 Nov-Dec;23(6):991-1003.