BurnsNCT00718978
Clinical Application of Autologous Three-Cellular Cultured Skin Substitutes (CSS)
A study testing CSS grafting in people with Burns and Ulcers, run by University of Roma La Sapienza at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Burns, Ulcers, Giant Nevi
- What is being tested?
- CSS grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2003to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- of extensive full-thickness loss of substance
Who cannot join
- location: face
- all contra indications for surgery
- coagulation disorders
- infection
- allergic reactions
- collagenopathies
Show all 9Show fewer
- malignant cancer and chemotherapy
- immunodeficiencies
- diabetes
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dipartimento Malattie Cutanee-Veneree e Chirurgia Plastica e Ricostruttiva universita' "La Sapienza" Roma
Roma, 00161
About this study
Official title: Clinical Application of Autologous Three-Cellular Cultured Skin Substitutes (CSS) Based on Esterified Hyaluronic Acid Scaffold: Our Experience
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.
Read the 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.
- Conditions
- Burns, Ulcers, Giant Nevi
- Being tested
- CSS grafting
- Keywords
- bioengineered, ski, keratinocytes, fibroblasts, skin, culture, autologous, CSS, full-thickness loss of substance from:, burns, ulcers, giant nevi, cicatricial outcomes
- Medical subject headings
- Burns, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSS graftingProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| B | Other | the investigators grafted sheets based on the HYAFF11p80® scaffold (the one with the lowest degree of esterification) Receives: Procedure: CSS grafting |
| A | Other | the investigators grafted sheets based on the HYAFF11® scaffold (the one with the highest degree of esterification). Receives: Procedure: CSS grafting |
| A-B | Other | the investigators grafted sheets based on the HYAFF11® scaffold and sheets based on the HYAFF11p80 ® scaffold Receives: Procedure: CSS grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSS graft take compare to the take of autografts confirmed by histological and macroscopic appearance
Measured: 3 years maximum
Secondary outcomes (1)
Final aesthetic outcome determined by the take of melanocytes
Measured: 3 years maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startJun 2003
- Primary completionJul 2004
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Investigators
- nicolo' scuderi, professor, Study chair, universita "la Sapienza" Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718978
- Sponsor's protocol ID
- 928/07
- Status last verified
- Jul 2008
- First submitted
- 18 Jul 2008
- Last updated
- 9 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1016/j.biomaterials.2007.12.024. Epub 2008 Jan 16.
PubMed 18201759Scuderi 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.
PubMed 20023246
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Autologous Three-Cellular Cultured Skin Substitutes (CSS) Based on Esterified Hyaluronic Acid Scaffold: Our Experience
- ClinicalTrials.gov ID
- NCT00718978
- Acronym / sponsor ID
- 928/07
- Conditions
- Burns, Ulcers, Giant Nevi
- Keywords
- bioengineered, ski, keratinocytes, fibroblasts, skin, culture, autologous, CSS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 21 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B | Other | Procedure: CSS graftingthe investigators grafted sheets based on the HYAFF11p80® scaffold (the one with the lowest degree of esterification) |
| A | Other | Procedure: CSS graftingthe investigators grafted sheets based on the HYAFF11® scaffold (the one with the highest degree of esterification). |
| A-B | Other | Procedure: CSS graftingthe investigators grafted sheets based on the HYAFF11® scaffold and sheets based on the HYAFF11p80 ® scaffold |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- of extensive full-thickness loss of substance
Key exclusion criteria (9 listed)
- location: face
- all contra indications for surgery
- coagulation disorders
- infection
- allergic reactions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSS graftinggrafting 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 | Procedure or surgery | A, A-B, B |
Primary outcome
CSS graft take compare to the take of autografts confirmed by histological and macroscopic appearance
Time frame: 3 years maximum
1 secondary outcome
Final aesthetic outcome determined by the take of melanocytes
Time frame: 3 years maximum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2008.
- Background: PubMed 18201759Scuderi 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.
- Derived from this study: PubMed 20023246Scuderi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
nicolo' scuderi, professor study chair
universita "la Sapienza" Roma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSS grafting in people with Burns and Ulcers, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSS graft take compare to the take of autografts confirmed by histological and macroscopic appearance (time frame: 3 years maximum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00718978, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2008.