Uncontrolled Clinical Trial of Quality- and Quantity-Cultured Peripheral Blood Mononuclear Cell Therapy for Androgenetic Alopecia

BACKGROUND: Androgenetic alopecia is caused by the effects of dihydrotestosterone on hair follicles and reduced follicular blood flow. This first-in-human study aims to evaluate the safety and efficacy of treatment with autologous MNC-QQ cells-a novel cell product previously established by the authors, derived from a serum-free quantity and quality control (QQ) culture of peripheral blood mononuclear cells (MNCs), which increases the vasculogenic ability of MNCs-in androgenetic alopecia. METHODS: In this single-arm, open-label clinical study, 5 men received subcutaneous injections of 1 × 10 7 autologous MNC-QQ cells into affected scalp areas. Follow-ups were conducted at 2 weeks and 1, 3, and 6 months after injection. Safety was evaluated with adverse event monitoring, scalp appearance, blood examination results, and vital signs. Effectiveness was assessed by comparing pre- and posttreatment photographs using a Hamilton-Norwood grading scale, trichoscopy, and psychological impact using the Skindex29 quality of life questionnaire. RESULTS: No patient experienced an adverse effect. Three patients showed improvement in Hamilton-Norwood stage based on photographic evaluation. The remaining 2 patients exhibited mild improvement, defined as visible enhancement in hair growth without a change in clinical stage. At 6 months after 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 quality of life. CONCLUSIONS: This study demonstrates the safety and effectiveness of MNC-QQ cell treatment for androgenetic alopecia. The results suggest MNC-QQ cells as an alternative therapy for androgenetic alopecia.