Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells
キーワード
概要
説明
Trial evaluating the safety and efficacy of olfactory mucosa-derived mesenchymal stem cells based therapy for the patients with chronic laryngeal and tracheal stenosis.
Mesenchymal stem cells are obtained from tissue biopsy of olfactory mucosa using explant method. Biomass of autologous mesenchymal stem cells in 10% human albumin solution is injected submucosally around and over the tissue after removal of a granuloma tissue during surgical intervention.
日付
| 最終確認済み: | 05/31/2019 |
| 最初に提出された: | 04/11/2017 |
| 提出された推定登録数: | 04/21/2017 |
| 最初の投稿: | 04/25/2017 |
| 最終更新が送信されました: | 06/04/2019 |
| 最終更新日: | 06/06/2019 |
| 実際の研究開始日: | 01/02/2017 |
| 一次完了予定日: | 01/03/2019 |
| 研究完了予定日: | 05/19/2019 |
状態または病気
介入/治療
Biological: Mesenchymal stem cell treated group
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: Mesenchymal stem cell treated group Patients treated according to current clinical protocols plus autologous olfactory mucosa-derived mesenchymal stem cells | Biological: Mesenchymal stem cell treated group Olfactory mucosa-derived mesenchymal stem cells |
| No Intervention: Control group Patients treated according to current clinical protocols |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - confirmed diagnosis of chronic laryngeal or tracheal stenosis; - absence of cartilage damage. Exclusion Criteria: - refuse of patient to participate in the trial; - acute infectious diseases; - chronic mental disorders with severe manifestations; - pregnancy/lactation; - intercurrent severe chronic diseases; - HIV, Hepatites B/C; - active tuberculosis; - alcohol use disorder/drug addiction; - cachexia of any origin; - malignant neoplasms. |
結果
主な結果の測定
1. Number of patients who didn't require the repeated surgical interventions [1 year]
二次的な結果の測定
1. Tracheostomy decannulation [6 month]
