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HAIR REGROWTH FOLLOWING A WNT-CONTAINING TREATMENT

HAIR REGROWTH FOLLOWING A WNT-CONTAINING TREATMENT; SAFETY AND EFFICACY IN A FIRST-IN-MAN PHASE I CLINICAL TRIAL

Ziering C, Zimber MP, Zeigler F, Hubka M, Mansbridge JP, Hubka K, Perez-Meza D, Naughton GK

Introduction

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 in the C57/Bl6 mouse model as well as in an exploratory first-in-human, Phase I clinical study in men with male pattern baldness.

In the HSC manufacturing process, neonatal dermal fibroblasts , which are closely related to hair follicle dermal papilla cells, are grown under hypoxic conditions of 3-5% oxygen, which is characteristic of the embryonic environment. Under these conditions the cells differentially express over 5000 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, stem cell markers are evident on the cells grown in the hypoxic bioreactors, including Nodal, brachyury, Nestin, and Oct 4 (Figure 1).

Figure 1: Hypoxic neonatal cells stained for stem cell-associated proteins (green) and counterstained with phalloidin (red) and DAPI (blue) to demonstrate the cytoskeleton (actin) and nuclei, respectively.

A. Nodal; B. Brachyury; C. Nestin; D. Oct4 (HRP detection system). Mag =40x

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