Efficacy of autologous dermal sheath cup cell transplantation in male and female pattern hair loss: A Single‐Arm, Multi‐Center, phase III equivalent clinical study

Abstract

AbstractA previous, proof‐of‐concept clinical study suggested that dermal sheath cup cell injections into the affected areas of male/female pattern hair loss (PHL) may have some amelioratory effects, the clinical efficacy of which needs further examination. A phase III equivalent clinical study was conducted to further probe the therapeutic potential of this novel approach and verify its safety and efficacy in improving the appearance of PHL. Thirty‐six participants with PHL were injected with dermal sheath cup cell harvested from non‐affected occipital hair follicles twice in quarterly intervals. Global photographic assessment and phototrichogram were performed in a blinded manner. Patient‐reported outcomes were assessed for 12 months. On global photographic assessment, 30% of the participants showed improvement. The analysis of phototricogram data detected the increases in the cumulative hair diameter, hair cross‐sectional area, and mean hair diameter of 107.6 ± 152.6 μm/cm2, 13069.1 ± 10960.7 μm2/cm2, and 0.9 ± 0.9 μm (ratios vs. baseline: +1.4%, +3.4%, and +2.2%), respectively. The female and high terminal hair ratio groups achieved better improvement. Of the total participants, 62.9% noted some degree of improvement. No serious adverse events were detected. This novel approach exhibited visible effects while ensuring safety and patient satisfaction. Therefore, it holds promise as a possible therapeutic option for treating PHL, especially in women.