San Diego’s Histogen Launches Clinical Trial
We’ve been keeping tabs on Histogen, a regenerative medicine company out of San Diego, which is actively recruiting and enrolling 27 participants to test a new potential treatment for female hair loss. The U.S. Food and Drug Administration approved Histogen’s Investigational New Drug application in June, clearing the way for the company’s Phase 1 clinical trial of its lead product, Hair Stimulating Complex, which Histogen calls HSC660.
The clinical trial will evaluate the safety of the injectable HSC660 treatment in women through a randomized, blinded, placebo-controlled study. Under the guidance of principal Investigator Dr. Kimberly Butterwick at Dermatology Cosmetic Laser Medical Associates, the study will also look at indicators of treatment efficacy.
So what is HSC660? Histogen describes it as a material produced starting with neonatal cells – or fibroblasts, which are the focus of intense study as they have advantages over stem cells, including being in plentiful supply and cost effective to harvest. Histogen grows these fibroblasts under simulated embryonic conditions, then employs a patented process they’ve developed to induce these cells to become multipotent stem cells. The process also leads to an upregulation of growth factors that have been shown to be important in stimulating the hair follicle, new hair growth and sustained hair viability. Key growth factors within HSC660 include keratinocyte growth factor (KGF), vascular endothelial growth factor (VEGF) and follistatin.
A news release issued by Histogen announcing the clinical trial noted that approximately 30 million women are affected by hair loss in the U.S. alone. As we at Arocha Hair Restoration have written about in the past, advanced hair restoration surgery techniques such as follicular unit transplantation (FUT) and other options can often help women experiencing pattern hair loss, particularly those in more advanced stages. Even so, the possibility of having an injectable treatment in the future that can reverse female hair loss is compelling.
"The potential of a simple, injected treatment that stimulates stem cells in the scalp to create new hair could be life changing,” said Dr. Butterwick. “We are excited to kick off the first trial of this novel HSC660 treatment in women."
While male pattern baldness has three main factors that interact – genetics, age and hormones – female hair loss can be caused by an array of factors including hormonal imbalance, stress, illness, chemical damage and chemotherapy. Dr. Bernard Arocha has posted an informative video about female pattern hair loss that everyone interested in the subject should review.
Based on research done so far, it appears HSC660 has the potential to induce new, cosmetically significant hair growth in men and women. In what Histogen describes as proof-of-concept clinical trials, HSC660 was tested for efficacy in treating male pattern baldness on fewer than 100 patients in Honduras and the Philippines, reporting statistically significant results and a strong safety profile.
In the first, nearly 85 percent of patients receiving a single treatment showed a significant increase in terminal hair count and hair thickness at 12 weeks. In the second, patients received two treatments six weeks apart. Significant improvements were observed in total hair count, terminal hairs and hair thickness at 12 weeks.
Another more recent 10-patient trial sponsored by a physician in the U.S. showed significant results for the therapy in both men and women. The results of that study may have influenced the decision to target women in this new clinical trial. Women reported a 100 percent response rate in the study.
While the science is certainly exciting and we will keep close tabs on news coming from Dr. Butterwick and Histogen, we were also excited by the fact that this research is focused on women. It hasn’t always been that way.
According to a 2009 analysis, women make up just 37 percent of research subjects, even though they comprise more than half the U.S. population. A 2017 meta-analysis of 2,742 case reports showed a “statistically significant gender bias against female case reports,” while the Society for Women’s Health Research notes that the richest charities aren’t pushing for the inclusion of more women in medical research and that only three percent of grant proposals measured gender differences.
Although researchers have reasoned that results on male subjects can easily be applied to women, research increasingly shows this argument is flawed. Men and women are often medically different.
No surprise there! Cheers to Histogen for a female-focused clinical trial on a potential new treatment for hair loss.
If you are a woman experiencing hair loss, call us today at 713-526-HAIR or 713-526-4247 to book a free consultation with Dr. Arocha.