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

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ClinicalTrials.gov Identifier: NCT00718978
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : September 9, 2008
Sponsor:
Information provided by:
University of Roma La Sapienza

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.

Condition or disease Intervention/treatment Phase
Burns Ulcers Giant Nevi Procedure: CSS grafting Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Application of Autologous Three-Cellular Cultured Skin Substitutes (CSS) Based on Esterified Hyaluronic Acid Scaffold: Our Experience
Study Start Date : June 2003
Actual Primary Completion Date : July 2004
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. CSS graft take compare to the take of autografts confirmed by histological and macroscopic appearance [ Time Frame: 3 years maximum ]

Secondary Outcome Measures :
  1. Final aesthetic outcome determined by the take of melanocytes [ Time Frame: 3 years maximum ]


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Ages Eligible for Study:   1 Year to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: nicolo' scuderi, Department of plastic and reconstructive Surgery
ClinicalTrials.gov Identifier: NCT00718978     History of Changes
Other Study ID Numbers: 928/07
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: September 9, 2008
Last Verified: July 2008

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

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents