根據研究文獻指出,外泌體可調控發炎反應、促進血管新生及神經修復、活化細胞、協助組織修復,並指出幹細胞外泌體具有臨床應用的潛力,未來將有機會成為再生醫療市場的新興產品,解決未被滿足的醫療需求 (unmet medical needs)。外泌體臨床(前)試驗應用廣泛,適應症如:腦神經相關退化性疾病、腦/心血管疾病、呼吸系統疾病、肝臟/腎臟/胰臟損傷、皮膚缺陷、軟骨受損、黃斑部病變等。
根據NIH臨床試驗資料庫 (ClinicalTrial.gov) 資料顯示,全球已有多件幹細胞外泌體臨床試驗正在進行,詳細整理如下表:
國際臨床試驗資料庫 (ClinicalTrial.gov)
搜尋關鍵字:stem cell, exosome,統計至 2022.08.02,篩選掉非幹細胞外泌體治療項目 (如:PRP、癌症檢測等)
|
適應症 |
外泌體來源 |
試驗發布日/臨床階段 |
NCT number |
|
糖尿病 (T1DM) |
UCB-MSCs |
May 14, 2014 Phase 2, 3 Trial |
|
|
原發性黃斑部裂 孔 |
UCB-MSCs |
February 19, 2018 Early Phase 1 |
|
|
缺血性腦中風 |
MSCs |
December 27, 2017 Phase 1, 2 Trial |
|
|
多重器官失能症 候群 |
MSCs |
April 22, 2020 Not Applicable (not yet recruiting) |
|
|
乾眼症 |
UBC-MSCs |
December 30, 2019 Phase 1, 2 Trial |
|
|
三叉神經痛 |
ESC-MSCs |
December 18, 2019 Not Applicable (pending) |
|
|
牙周病 |
AD-MSCs |
February 17, 2020 Early Phase 1 Trial |
|
|
色素性視網膜炎 |
UBC-MSCs |
July 1, 2022 Phase 2, 3 Trial |
|
|
憂鬱/焦慮/失智 症 |
MSCs (Kimera Coporation) |
December 18, 2019 Not Applicable (suspended) |
|
|
複雜性肛瘺 |
Placenta-MSCs |
December 22, 2021 Phase 1, 2 Trial |
|
|
阿茲海默症 |
AD-MSCs |
May 15, 2020 Phase 1, 2 Trial |
|
|
急性呼吸窘迫 |
MSCs |
November 30, 2020 Phase 1, 2 Trial |
|
|
退化性半月板損 傷 |
Synovial-fluid MSCs |
March 2022 Phase 2 Trial |
|
|
健康患者霧化吸 入幹細胞外泌體 測試耐受性 |
AD-MSCs |
March 12, 2020 Phase 1 Trial |
|
|
糖尿病造成皮膚 潰瘍 |
MSCs |
February 17, 2022 Not Applicable (not yet recruiting) |
|
|
慢性潰瘍傷口 |
UBC-MSCs |
October 22, 2019 Phase I |
|
|
表皮分解性水皰 症 |
MSCs |
November 22, 2019 Phase 1, 2 Trial |
|
|
促進骨移植後骨 生成 |
AD-MSCs |
August 10, 2021 |
|
|
肺部感染損傷 |
MPCs (progenitor cells) |
September 10, 2020 Phase 1, 2 Trial |
|
|
COVID-19 |
MSCs |
January 31, 2022 Phase 2, 3 Trial |
|
|
AD-MSCs |
February 19, 2020 Phase 1 Trial |
||
|
MSCs |
July 29, 2020 Phase 1, 2 Trial |
||
|
October 26, 2020 Phase 2 Trial |
|||
|
Human amniotic
fluid (HAF) |
May 12, 2020 Phase 1, 2 Trial |
||
|
UBC-MSCs |
May 24, 2022 Phase 1 Trial |
||
|
MSCs |
March 15, 2021 Phase 1, 2 Trial |
||
|
Human embryonic kidney T-REx™-293 cells (overexpressing CD24) |
July 20, 2021 Phase 2 |
(臨床試驗資料庫網址:https://clinicaltrials.gov/)
UCB-MSCs:臍帶幹細胞
AD-MSCs:脂肪幹細胞
MSCs:間質幹細胞
相關報導:https://www.mohw.gov.tw/cp-4630-54763-1.html
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