Clinical Application of Autologous Three-Cellular Cultured Skin Substitutes (CSS)
Clinical Application of Autologous Three-Cellular Cultured Skin Substitutes (CSS) Based on Esterified Hyaluronic Acid Scaffold: Our Experience
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Roma、イタリア、00161
- Dipartimento Malattie Cutanee-Veneree e Chirurgia Plastica e Ricostruttiva universita' "La Sapienza" Roma
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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他の:B
the investigators grafted sheets based on the HYAFF11p80® scaffold (the one with the lowest degree of esterification)
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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
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他の:A
the investigators grafted sheets based on the HYAFF11® scaffold (the one with the highest degree of esterification).
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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
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他の:A-B
the investigators grafted sheets based on the HYAFF11® scaffold and sheets based on the HYAFF11p80 ® scaffold
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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
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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CSS graft take compare to the take of autografts confirmed by histological and macroscopic appearance
時間枠:3 years maximum
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3 years maximum
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二次結果の測定
結果測定 |
時間枠 |
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Final aesthetic outcome determined by the take of melanocytes
時間枠:3 years maximum
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3 years maximum
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協力者と研究者
捜査官
- スタディチェア:nicolo' scuderi, professor、universita "la Sapienza" Roma
出版物と役立つリンク
一般刊行物
- 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.
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 928/07
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
CSS graftingの臨床試験
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University Hospital Bispebjerg and FrederiksbergRigshospitalet, Denmark終了しました
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Cochlearnumerics data GmbH完了
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Johns Hopkins Bloomberg School of Public HealthUnited States Agency for International Development (USAID)完了
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Rigshospitalet, DenmarkHvidovre University Hospital; Bispebjerg Hospital募集
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Memorial Sloan Kettering Cancer CenterUniversity of Virginia積極的、募集していない
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CochlearAvania; QbD Clinical募集