Histogen, Inc., a regenerative medicine company developing innovative therapies for conditions including hair loss and cancer, has announced that the United States Patent & Trademark Office has issued patent 8,524,494, entitled "Low Oxygen Tension and bFGF Generates a Multipotent Stem Cell from a Fibroblast In Vitro" to the Company.
The issued patent covers Histogen's method of triggering the de-differentiation of fibroblast cells into multipotent stem cells through low oxygen and special culture conditions. The resulting multipotent cells naturally secrete a variety of soluble and insoluble molecules that are the basis for Histogen's products.
"Histogen's process is uniquely capable of harnessing all of the benefits and excitement of stem cell therapies without any of the ethical, safety or sourcing concerns," said Dr. Gail K. Naughton, Histogen CEO and Chairman of the Board. "Issuance of this patent adds great strength to our technology, and value to our partners and products."
Current stem cell-derived therapies utilize embryonic stem cells or genetically-manipulated induced pluripotent stem cells, both of which have an inherent ethical and scientific risk, and raise a number of regulatory issues. Still, enthusiasm continues to build around stem cells, both for their potential to address serious medical conditions as well as their aesthetic benefits for beauty and rejuvenation.
Through Histogen's technology process, the Company is uniquely able to begin with newborn fibroblasts cells, a safe, well-established and non-controversial cell source, and convert the cells into multipotent stem cells without genetic manipulation. The cells express key stem cell markers including Oct4, Sox2 and Nanog, and secrete a distinctive composition of growth factors and other proteins known to stimulate stem cells in the body, regenerate tissues, and promote scarless healing.It is the soluble and insoluble compositions of multipotent proteins and growth factors which make up Histogen's products, with numerous applications. Histogen's lead product, Hair Stimulating Complex (HSC) has shown success in two Company-sponsored clinical trials as an injectable treatment for alopecia. In addition, the human multipotent cell conditioned media produced through Histogen's process can be found in the ReGenica line of skincare products, currently being distributed by Suneva Medical in partnership with Obagi Medical Products. Further indications of the materials currently being developed include oncology and orthopedics.