Hair Regrowth Following a Wnt- and Follistatin-Containing Treatment: Safety and Efficacy in a First-in-Man Phase 1 Clinical Trial

In a first-in-man phase 1 clinical trial conducted 12 years ago, a bioengineered, non-recombinant, human cell-derived formulation, termed Hair Stimulating Complex (HSC), was tested for its hair growth activity in male pattern baldness. The HSC contained follistatin, Wnt 7a, and wound healing growth factors. The double-blind, placebo-controlled, randomized single site trial involved 26 subjects who tolerated the single, intradermal injection of HSC well, with no adverse reactions reported. At 12 weeks, HSC-treated sites showed significant improvements in hair shaft thickness, thickness density, and terminal hair density. At one year, a statistically significant increase in total hair count continued to be seen. The study concluded that a single intradermal administration of HSC improved hair growth in subjects with androgenetic alopecia.