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

Abstract

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. In this single-arm, open-label clinical study, five male patients received subcutaneous injections of 1×107 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). 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. 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.