707 Hypoxia induced Multipotent Stem Cell-Secreted Proteins Induce Hair Growth in a Phase 1a/2b trial in Male Pattern Baldness

Abstract

A Phase 1b/2a clinical trial was performed to study the safety and efficacy of a bioengineered human cell-derived formulation, termed Hair Stimulating Complex (HSC), in stimulating hair growth and preventing hair loss in subjects with male pattern baldness. HSC contains naturally secreted growth factors known to be important in hair growth, including follistatin, KGF, VEGF, PLGF, HGF, and angiogenin. These growth factors are key to stimulating the hair follicle stem cells, supporting keratinocyte migration into the follicle to result in new hair formation, and promoting angiogenesis to supply increased nutrients to support the highly metabolically active anagen phase. Several ELISA and cell-based assays, including a human outer root sheath assay, are used to release the clinical product. The study was a double-blind, 2:1 randomized, single center trial in 36 subjects with Norwood Hamilton scores of 3V, 4, and 5. All subjects tolerated well the twenty 0.1cc intradermal injections, distributed between the vertex and temporal regions, administered at baseline, 6, and 12 weeks, with no signs of a serious adverse reaction reported. Canfield image analysis of treated sites were taken at baseline and 18 weeks. At the 18-week time point, 75% of the HSC subjects responded to treatment and showed new hair growth and a cessation in hair loss whereas 63% of the control subjects continued to lose hair. Canfield imaging at week 26 will assess total hair count numbers as well as vellus, non-vellus hairs and hair thickness. These results clearly demonstrate the safety and efficacy of intradermal injections of HSC in subjects with androgenetic alopecia and support initiating a larger phase 2 dosing study.