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07-15-12 | Posted by

In 2007, Dr. Gail Naughton founded Histogen, Inc., a regenerative medicine company based on the philosophy of naturally produced products from newborn fibroblasts—an alternative to the use of embryonic stem cells or animal components. A respected scientist with extensive experience in the field, Dr. Naughton has spent more than 25 years researching the tissue engineering process and holds nearly 100 US and foreign patents. With her discovery that the proteins and growth factors produced by newborn fibroblasts held therapeutic and biomedical applications, she developed Histogen’s core technology in order to create products—with both potential biomedical and cosmetic benefits—based on these proteins.


Tell us about your history and how you came to found Histogen.

I have a long history with tissue engineering and regenerative medicine. After founding Advanced Tissue Sciences in 1987, I served as President of the Company, overseeing cell-based products for severe burns (TransCyte), diabetic wounds (Dermagraft) and human collagen (Cosmederm) from concept to market.

In working with neonatal fibroblasts, skin cells isolated from routine circumcisions, for many years, it became clear how adaptable and responsive these cells are to their environment. After joining San Diego State University as Dean of the College of Business Administration in 2003, I continued individual research focused on growing cells under simulated embryonic conditions to see if they could be induced into a stem cell-like state. We found that, when grown under embryonic-like conditions of low oxygen and suspension, the cells do indeed become multipotent and the products they produce have the ability to stimulate scarless wound healing and regeneration of tissues and organs. I founded Histogen in 2007 based upon this research and technology.

How would you describe Histogen’s philosophy?

Histogen’s philosophy is to develop naturally produced, cell-secreted compositions of proteins and growth factors that will stimulate a person’s own stem cells to regenerate tissues and organs without the use of controversial embryonic stem cells or animal components.

What makes newborn fibroblast-based products uniquely suited for medical and therapeutic products?

Neonatal fibroblasts are a safe, reliable, and non-controversial cell type. They undergo extensive testing for all known pathogens and viruses, and produce consistent products for therapeutic and aesthetic applications. Although our manufacturing process begins with newborn fibroblasts, Histogen produces a complex of proteins that is very different from fibroblast-based products. This is because we have a unique method for growing the cells that mimics the embryonic environment, including very low oxygen and suspension. These growing conditions coax the cells into acting as they would in the womb, and within a few days the revert to a multipotent, stem cell-like state, and produce proteins and growth factors, including follistatin and Stem Cell Factor, which are known to stimulate stem cells in the body.

How does the medical science behind Histogen relate to the beauty industry?

The growth factor composition naturally produced in Histogen’s proprietary manufacturing process has been shown to stimulate skin cells to rapidly proliferate and secrete collagens and other extracellular matrix proteins that are responsible for keeping skin soft and youthful. There are also applications for use of the material as a dermal filler, and in scarless wound healing post elective surgery.

Tell us about the oncology applications of Histogen’s technology.

The embryonic-like proteins produced in Histogen’s process have been shown to turn on a gene in cancer cells that induces them to proceed down the path of a controlled cell death, called apoptosis. This phenomenon has been seen with over 21 human cancer cell lines both in vitro as well as in 2 animal models, including skin cancers such as melanoma and squamous cell carcinoma. We would be very interested and excited to test the ability of our material to prevent skin cancer as well as reverse precancerous skin lesions.

Are there any upcoming developments for Histogen that you are excited about?

We are excited about Suneva’s upcoming launch of ReGenica, containing our multipotent cell conditioned media, for anti-aging and post resurfacing applications. We also look forward to announcing additional partnerships for aesthetic applications such as accelerating the benefits of resurfacing procedures. Finally, we are very excited about presenting 12 week data from Histogen’s Phase I/II clinical trial for hair growth at the Society of Investigative Dermatology Annual Meeting in May.

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