4
0全球超5亿人受骨关节炎困扰，传统疗法仅能缓解症状无法逆转软骨退化。最新无细胞外泌体疗法完成首次人体膝关节注射，首例患者症状明显改善，目前相关临床试验正在推进，需警惕市面上非合规的外泌体相关产品。
参考文献：
Figueroa-Valdés A, Luz-Crawford P, et al. (2025) "Clinical-grade extracellular vesicles derived from umbilical cord mesenchymal stromal cells: preclinical development and first-in-human intra-articular validation as therapeutics for knee osteoarthritis" Journal of Nanobiotechnology 2025-01-13，DOI: 10.1186/s12951-024-03088-x Semantic Scholar
Matas J, et al. (2019) "Umbilical Cord-Derived MSCs for Knee Osteoarthritis: Repeated MSC Dosing Is Superior to a Single Dose and to Hyaluronic Acid in a Controlled Randomized Phase I/II Trial"（NCT02580695）Stem Cells Translational Medicine PMC
I期注册试验 NCT06431152（EXO-OA01）：12名KL II-III级患者，3剂量组（2×10⁹/6×10⁹/2×10¹⁰颗粒）单次关节腔注射，随访12个月 Veeva CTV
(2026) "Safety and Efficacy of Intra-Articular Injection of UC-EVs in Knee Osteoarthritis: A Retrospective Study"（VAS平均下降38.8mm，KL 2-3级优于4级）Orthopedics Healio
综述：MSC-EV治疗骨关节炎的临床前与临床转化现状（5项进行中关节腔注射试验）Bioengineering 2024 PMC
