La Jolla’s
Histogen has begun clinical testing of a hair regrowth treatment in women.
The injected treatment contains stem cell secretions that stimulate hair follicles. An earlier version is already being tested in men.
The early-stage or Phase 1 trial is taking place at the La Jolla clinic of Dr. Kimberly Butterwick, a dermatologist. Women interested in taking part in the trial can call 858-657-1004 for more information.
About 30 million American women are affected by hair loss,
according to the National Institutes of Health. This most often occurs with menopause, along with autoimmune disease, and cancer chemotherapy.
Gail Naughton, Histogen’s founder and chief scientific officer, said about two-thirds of these women might benefit from the treatment, called HSC660,
The study will treat 27 women in a randomized, blinded, placebo-controlled fashion to assess safety. In addition, researchers will look for signs of efficacy.
The trial will run for 22 weeks, so the results will be known before year’s end, she said.
“We are planning after this trial a trial for women who are in late-stage ovarian cancer,” Naughton said.
Naughton she had originally believed that hair loss must be a minor factor to patients when confronting a life-threatening disease. But an oncologist helping plan the trial told that hair loss is “emotionally traumatizing” to many women.
“He said, Gail, you don’t understand. The first question they ask me is, am I going to have chemo? The second question they ask, is am I going to lose my hair?”
Studies have shown that patients do better when they don’t look sick, Naughton said. And losing hair is a sign of sickness that’s impossible to overlook.
Privately held Histogen is in more advanced testing of an earlier version of HSC660 in men. This version was also tested in five women by an independent researcher. All five regenerated hair.
A late-stage or Phase 3 trial for men has begun in Mexico, Naughton said. Anticipating success, the company is looking toward commercialization.
“We're in very late-stage negotiations with some huge retail partners,” Naughton said. A deal should be concluded in the next few months, she said.
Histogen produces its stem cells from skin cells called fibroblasts. These stem cells exude substances called growth factors. They are known to cause dormant follicles to resume hair production, and maintain the new hair.
Histogen converts the fibroblasts by placing them into simulated embryonic conditions, including suspending them in liquid and low oxygen. The cells revert to a partially embryonic state, which causes them to emit the growth factors.
