Shieh Ju-Sheng, Chin Yu-Tang, Yeh Tsu-Te, Guo Jiong Jiong, Chang Fung-Wei, Cheng Hui-Rong, Hsu Hung-Han, Huang Wei-Lun, Huang Han-Hsiang, Hsieh Ya-Yu, Chiang Chien-Ping, Wang Shih-Ching
Department of Periodontology, School of Dentistry, Tri-Service General Hospital, National Defense Medical Center, Taipei 114202, Taiwan.
Department of Orthopaedic Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei 114202, Taiwan.
Curr Issues Mol Biol. 2025 Jul 11;47(7):539. doi: 10.3390/cimb47070539.
Small extracellular vesicles (sEVs) derived from mesenchymal stem cells have emerged as promising therapeutic agents in regenerative dermatology. This study evaluated the safety and efficacy of Bio-Pulsed avian mesenchymal stem cell-derived sEVs (AMSC-sEVs), topically applied for hair follicle stimulation and skin rejuvenation. Two prospective, single-arm clinical trials were conducted: one involving 30 participants using a hair ampoule over 60 days, and the other involving 30 participants applying a facial essence for 28 days. Objective measurements demonstrated significant improvements in the anagen/telogen hair ratio, reduced shedding, increased collagen density, and reduced wrinkle depth and pigmentation. Small RNA sequencing and qPCR profiling confirmed that Bio-Pulsed AMSC-sEVs were enriched with regenerative microRNAs, such as miR-21-5p and miR-199a-5p, associated with anti-inflammatory and anti-aging effects. No adverse events were reported. These findings suggest that Bio-Pulsed AMSC-sEVs may offer a safe, non-invasive, and cell-free approach to enhance skin and hair regeneration in human subjects.
源自间充质干细胞的小细胞外囊泡（sEVs）已成为再生皮肤病学中颇具前景的治疗剂。本研究评估了经局部应用以刺激毛囊和嫩肤的生物脉冲禽间充质干细胞衍生的sEVs（AMSC-sEVs）的安全性和有效性。进行了两项前瞻性单臂临床试验：一项涉及30名参与者，使用生发安瓿60天，另一项涉及30名参与者，使用面部精华液28天。客观测量结果表明，生长期/休止期毛发比例显著改善、脱发减少、胶原蛋白密度增加、皱纹深度和色素沉着减轻。小RNA测序和qPCR分析证实，生物脉冲AMSC-sEVs富含与抗炎和抗衰老作用相关的再生微小RNA，如miR-21-5p和miR-199a-5p。未报告不良事件。这些发现表明，生物脉冲AMSC-sEVs可能为增强人类受试者的皮肤和毛发再生提供一种安全、非侵入性且无细胞的方法。
