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Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars

2021年9月17日 更新者：Castle Creek Biosciences, LLC.

A Phase II, Double-Blind, Randomized, Placebo-Controlled Pilot Study of Azficel-T for the Treatment of Restrictive Burn Scars

This Phase II, double-blind, randomized, placebo-controlled pilot study is designed to determine whether injection of autologous fibroblasts can increase the mobility (decrease the restriction) of burn scars. The study will assess the effects of azficel-T (autologous fibroblasts) in subjects who have a unilateral burn scar that is no deeper than the fascia (i.e., underlying structures including ligament, tendon, muscle, and bone must not contribute to the restriction) and that is either:

  1. An axillary scar causing 20-60% restriction of shoulder adduction
  2. An anterior elbow scar causing 20-60% restriction of elbow extension
  3. A dorsal or palmar lesion of a single finger causing 20-60% restriction of flexion or extension

Subjects will each receive 2 injections of azficel-T or placebo administered 14 days (± 7 days) apart (depending on cell availability) and will be followed for efficacy (including range of motion measurements, scar pain and ability to perform activities) to Visit 7 and for safety to Visit 9 at 1 year.

調査の概要

状態

終了しました

条件

介入・治療

研究の種類

介入

入学 (実際)

5

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • California
      • Sacramento、California、アメリカ、95817
        • Univ of California David Medical Center
      • San Diego、California、アメリカ、92103
        • Univ of California San Diego
    • Florida
      • Miami、Florida、アメリカ、33136
        • Division of Burns and Trauma, Jackson Memorial Hospital
    • Illinois
      • Maywood、Illinois、アメリカ、60153
        • Loyola University Medical Center
    • Indiana
      • Indianapolis、Indiana、アメリカ、46202
        • Richard M. Fairbanks Burn Center
    • New York
      • Garden City、New York、アメリカ、11530
        • Long Island Plastic Surgical Group
    • Pennsylvania
      • Allentown、Pennsylvania、アメリカ、18103
        • Lehigh Valley Health Network
      • Pittsburgh、Pennsylvania、アメリカ、15213
        • Center for Innovation in Restorative Medicine
    • Washington
      • Seattle、Washington、アメリカ、98104
        • Univ of Washington, Harborview Medical Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Subject is at least 18 years of age

  2. Subject has a unilateral burn scar of a jointed area (i.e., finger, elbow, shoulder) that is no deeper than the fascia (i.e., underlying structures including ligament, tendon, muscle, and bone must not contribute to the restriction) and that is either:

    1. An axillary scar causing 20-60% restriction of shoulder abduction
    2. An anterior elbow scar causing 20-60% restriction of elbow extension
    3. A dorsal or palmar lesion of a single finger causing 20-60% restriction of flexion or extension
  3. Subject's burn scar to be treated is <100 sq cm in size
  4. Injury occurred ≤ 36 months prior to screening
  5. By the Investigator's assessment, physical therapy will not provide significant continuous improvement to the range of motion of the subject's joint
  6. Subject agrees to maintain any current physical therapy regimen for the duration of the study
  7. Subject must be able to provide written informed consent and comply with the study requirements
  8. Females of childbearing potential must have a negative urine pregnancy test at the screening visit and prior to the first treatment, and must agree to use a reliable means of birth control for the duration of the study
  9. Subject has healthy, non-scarred post auricular skin area suitable for biopsy
  10. Subject must have a normal complete blood count (CBC) and chemistry panel within 90 days prior to enrollment

Exclusion Criteria:

  1. Restrictive burn scars that are primarily classified as keloid scars
  2. Subjects for whom a post auricular biopsy cannot be collected for azficel-T production
  3. Sunburn or sun damage in the area that will be used for biopsy
  4. Plans to initiate any other new scar therapy during the study period
  5. Treatment with an investigational product or procedure within 30 days prior to study enrollment or plans to participate in another clinical trial during the course of this study
  6. History of active autoimmune disease or organ transplantation
  7. Diagnosis of cancer, including basal cell carcinoma, unless successfully treated or in remission for a minimum of 6 months
  8. Known genetic disorders affecting fibroblasts or collagen, such as achondroplasia, osteogenesis imperfecta, epidermolysis bullosa, ataxia-telangiectasia, Ehlers Danlos syndrome, etc.
  9. Active systemic infection
  10. Requires chronic antibiotic or steroidal therapy
  11. Any conditions that are considered by the Investigator to be contraindications to biopsy or injection
  12. Pregnant or lactating women, or women trying to become pregnant during the study
  13. Subject has any disorder that may prevent compliance, such as history of chronic alcohol or drug abuse, significant mental or nervous disorder or other illness that would, in the Investigator's opinion, interfere with the study
  14. Presence of other disease or condition that would result in impairment of the range of motion of the extremity, e.g., rheumatoid arthritis or stroke

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Autologous fibroblasts
Autologous fibroblasts grown in culture from skin biopsy taken from patient. The cells will be injected into the scars to be treated.
生物学的：Autologous fibroblasts
他の名前：
  • Azficel-T
プラセボコンパレーター：Sterile saline
Sterile saline will be injected into the scar to be evaluated.
生物学的：Autologous fibroblasts
他の名前：
  • Azficel-T
生物学的：placebo sterile saline

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
メジャーの説明
時間枠
Percentage Change From Baseline (CFB) of Range of Motion (ROM) of the Affected Joint
時間枠：Baseline and post-treatment (visit occurred between 194 - 208 days from baseline)
Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.
Baseline and post-treatment (visit occurred between 194 - 208 days from baseline)
Percentage CFB of ROM of the Affected Joint
時間枠：Baseline and post-treatment (visit occurred between 23 - 37 days from baseline)
Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.
Baseline and post-treatment (visit occurred between 23 - 37 days from baseline)
Percentage CFB of ROM of the Affected Joint
時間枠：Baseline and post-treatment (visit occurred between 53 - 67 days from baseline)
Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.
Baseline and post-treatment (visit occurred between 53 - 67 days from baseline)
Percentage CFB of ROM of the Affected Joint
時間枠：Baseline and post-treatment (visit occurred between 93 - 97 days from baseline)
Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.
Baseline and post-treatment (visit occurred between 93 - 97 days from baseline)
Percentage CFB of ROM of the Affected Joint
時間枠：Baseline and post-treatment (visit occurred between 113 - 127 days from baseline)
Percentage CFB was calculated by subtracting the baseline ROM measurement from the post-treatment ROM measurement, divided by the baseline ROM measurement, and multiplying by 100.
Baseline and post-treatment (visit occurred between 113 - 127 days from baseline)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Castle Creek Biosciences, LLC.

捜査官

  • 主任研究者：Daniel D Lozano, MD、Lehigh Valley Health Network

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2013年5月1日

一次修了 (実際)

2016年5月1日

研究の完了 (実際)

2016年7月1日

試験登録日

最初に提出

2013年5月10日

QC基準を満たした最初の提出物

2013年5月20日

最初の投稿 (見積もり)

2013年5月21日

学習記録の更新

投稿された最後の更新 (実際)

2021年10月13日

QC基準を満たした最後の更新が送信されました

2021年9月17日

最終確認日

2021年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • FI-B-003

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