Androgenetic alopecia is a widespread cosmetic and
medical disorder for which there exist few treatment options. The current therapeutic strategies including surgical, pharmaceutical, and cosmetic interventions are limited in
approach and success. We have developed a bioengineered human cell-derived formulation, termed Hair Stimulating Complex (HSC) that consists of a number of human growth factors
and morphogens recognized to be critical to the induction and maintenance of hair follicle growth and activity. Here we report that the preparation is safe as applied and
showed effectiveness in stimulating hair growth following the clinical administration of HSC to men with male-pattern baldness in a first-in-human, phase 1 clinical study.
In the HSC manufacturing process, neonatal dermal fibroblasts, which are closely related to hair follicle dermal papilla cells, are seeded onto microcarrier beads and grown in
suspension culture under hypoxic conditions that simulate the embryonic environment. Under these conditions, the cells differentially express over 5,000 genes compared to
cells grown in normoxic environments. Several of the upregulated genes expressed in the hypoxic cells are associated with pluripotent and follicular stem cells including LnX2,
SOX21, Nestin, NFATc1, Krt15, POU5F1 (OCT4), SOX2 and Nanog. In addition, WNT7a, VEGF, FGF, KGF and follistatin are upregulated in these cells. In the adult, Wnt proteins have
been found to play an essential role in induction of the dermal papilla1,2 and triggering of stem cell activity in keratinocytes3 to produce new hair follicles and growth.
Follistatin is an antagonist of activin and BMP, which are involved in maintaining a slow cycling stem cell phenotype in resting hair follicles.4 The exogenous administration
of Wnt proteins and follistatin to the scalp represents a novel and practical way to ameliorate and reverse androgenetic alopecia and other related hair loss disorders. The
presence of Wnt proteins
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