Bioengineered Exosomal Hair Growth Factors Complex in Upregulating HFDPCs, Downregulating IL-6, IL-1β in Hair Growth.

Abstract

This study aims to evaluate the safety and therapeutic efficacy of a novel Bioengineered Exosomal Hair Growth Factors Complex (BEHC™) for hair growth that amalgamates bioengineered exosomes with biomimetic polypeptides QR678 Nexo™ targeting androgenetic alopecia (AGA). The formulation's effectiveness was rigorously evaluated through both in vitro and in vivo experimental paradigms. In vitro, human follicle dermal papilla cells (HFDPCs) were cultured and treated with the novel formulation under study. Cell viability and proliferative responses were quantified using MTT assays, while anti-inflammatory efficacy was assessed by measuring mRNA expression levels of interleukin-6 (IL-6) and interleukin-1 beta (IL-1β). In vivo, an open-label prospective clinical study involved 85 human participants (Indian men and women aged 20-60 years), with efficacy metrics including hair pull tests, photographic evaluations, videomicroscopic assessments, and patient-reported outcomes across eight treatment sessions. Safety profiles were monitored through physical examinations and participant-reported adverse events. In vitro findings showed a statistically significant enhancement in human follicle dermal papilla cells (HFDPC) proliferation (172.4% relative to control) and down-regulation of IL-6 and IL-1β mRNA levels. In vivo, the hair pull test revealed a reduction in hair shedding from an average of 7.8 to 1.4 hairs. Videomicroscopic analyses indicated elevations in terminal hair counts and shaft diameters, with sustained enhancements in hair density two months post-treatment. The Bioengineered Exosomal Hair Growth Factors Complex (BEHC™) is a promising minimally invasive intervention for managing hair loss, demonstrating enhanced therapeutic efficacy while minimizing adverse effects, marking a significant advancement in regenerative dermatology.