Hair regrowth following a Wnt- and follistatin containing treatment: safety and efficacy in a first-in-man phase 1 clinical trial.

Research has shown the importance of follistatin, Wnt 7a, and wound healing growth factors on the stimulation of bulge cells and inter-follicular stem cells to induce hair growth. We have studied the effects of a bioengineered, non-recombinant, human cell-derived formulation, termed Hair Stimulating Complex (HSC), containing these factors to assess its hair growth activity in male pattern baldness. HSC showed in vitro Wnt activity and contained follistatin, KGF, and VEGF. The clinical study was a double-blind, placebo-controlled, randomized single site trial and was designed to evaluate safety of the HSC product and assess efficacy in stimulating hair growth. All 26 subjects tolerated the single, intradermal injection of HSC procedures well, and no signs of an adverse reaction were reported. Histopathological evaluation of the treatment site biopsies taken at 22 and 52 weeks post-treatment revealed no abnormal morphology, hamartomas, or other pathological responses. Trichoscan image analysis of HSC-treated sites at 12 and 52 weeks showed significant improvements in hair growth over the placebo. At the initial 12-week evaluation period, HSC-treated sites demonstrated an increase in hair shaft thickness (6.3%±2.5% vs. -0.63%±2.1%; P=0.046), thickness density (12.8%±4.5% vs. -0.2%±2.9%; P=0.028), and terminal hair density (20.6±4.9% vs. 4.4±4.9%; P=0.029). At one year, a statistically significant increase in total hair count (P=0.032) continued to be seen. These results demonstrate that a single intradermal administration of HSC improved hair growth in subjects with androgenetic alopecia and is a clinical substantiation of previous preclinical research with Wnts, follistatin, and other growth factors associated with wound healing and regeneration.

Hypoxic conditioned culture medium from fibroblasts grown under embryonic-like conditions supports healing following post-laser resurfacing.

OBJECTIVES: Treatment of facial skin perturbed by laser resurfacing with a novel, topical hypoxic conditioned culture medium (HCCM) product results in apparent, accelerated wound recovery time. The HCCM product is conditioned by neonatal fibroblasts under hypoxic conditions and used as the active ingredient in a formulated topical lotion. The HCCM contains significant quantities of growth factors such as vascular endothelial growth factor, keratinocyte growth factor, and interleukin-8. As these molecules are known to play an important role in normal wound healing in vivo, we conducted a pilot clinical evaluation "Proof of Concept" in which individuals, after receiving laser resurfacing, were instructed to use either active or placebo lotion on their abraded skin. METHODS: The end points used were clinical assessment of the time to complete healing, clinical and bioinstrumental mexameter measurements of erythema, and the number of days of rescue petrolatum use by patients, post-laser. RESULTS: Day 7, post-laser treatment, resulted in a greater improvement in erythema, and re-epithelization of the peri-oral and peri-ocular regions in subjects using the active lotion vs. placebo control as determined by blinded, clinical evaluation of gross photographs and bioinstrumental mexameter measurements. A statistically significant reduction in rescue petrolatum use in active lotion-treated subjects was reported. Finally, no attendant cutaneous safety concerns (e.g., irritant/allergic dermatitis) were reported with either active or placebo lotion. CONCLUSIONS: This HCCM product may have broad applications within the field of skin wound repair.