Uncontrolled Clinical Trial of Quality- and Quantity-cultured Peripheral Blood Mononuclear Cell Treatment for Androgenic Alopecia

Background: Androgenic alopecia is caused by the effects of dihydrotestosterone on hair follicles and reduced follicular blood flow. We have previously established MNC-QQ cells from a serum-free quantity and quality control culture of peripheral blood mononuclear cells, enhancing vasculogenic potential. The first-in-human study aimed to evaluate the safety and efficacy of autologous MNC-QQ cell therapy in androgenic alopecia. Methods: In this single-arm, open-label clinical study, five male patients received subcutaneous injections of 1×10 7 autologous MNC-QQ cells into affected scalp areas. Follow-ups were conducted at two weeks, one-, three-, and six- months post-injection. Safety was evaluated via adverse event monitoring, scalp appearance, blood examination results, and vital signs. Effectiveness was assessed by comparing pre- and post-treatment photographs using a Hamilton-Norwood grading scale, trichoscopy, and psychological impact using the Skindex29 questionnaire for quality of life (QOL). Results: None of the patients experienced any adverse effects. Three patients showed improvement in Hamilton-Norwood stage based on photographic evaluation. The remaining two patients exhibited mild improvement, defined as visible enhancement in hair growth without a change in clinical stage. At six months post-treatment, significant increases were observed in total hair count (1.207 ± 0.1617-fold, p < 0.05), hair density (1.196 ± 0.146-fold, p<0.05), hair mass (1.427 ± 0.155-fold, p <0.01), mean hair thickness (1.212 ± 0.104-fold, p<0.05), and terminal hair density (1.780 ± 0.337-fold, p <0.01). All patients showed improvements in QOL. Conclusions: We demonstrated the safety and effectiveness of MNC-QQ cell treatment for androgenic alopecia. Our results suggest MNC-QQ cells as an alternative therapy for androgenic alopecia.