Results of a five-month clinical trial of a new hair loss product released by a small biotechnology firm appear promising but researchers say it’s early stages and the trial is currently still in progress, which means another effective hair loss treatment may be years away, if at all.
The current hair loss treatments that prove successful are so because they’ve been through years of controlled, clinical trials to demonstrate how they work and their results. They are then subject to approval by the FDA and licensing by the MHRA - the regulatory bodies in the US and UK, respectively, that are responsible for granting licenses to new drugs so they can be sold publicly – before they are deemed not only effective, but also safe to use. There are currently two hair loss treatments that have have demonstrated continuously good results.
Histogen, an 18-person company which opened in 2007, is excited about the initial results from their independent study which involved 25 men aged 18 to 45 with varying stages of male pattern baldness.
“These results appear to be phenomenal, although this trial is still in the very early stages,” Dr Craig Ziering, the principal investigator of the study said.
Whilst there are no published results and the trial is still on-going, Histogen has reported that they are planning to meet with the FDA.
The formula, called ReGenica, was developed using man-man fibroblasts and early stem-cells, grown in an environment that mimics embryonic conditions. The fibroblasts are thought to cause certain proteins, named WNT proteins, to be produced. In mice, WNT has been shown to be responsible for initiating the formation of new hair follicles and improving function in existing follicles.
Histogen had previously conducted independent research that suggested ReGenica stimulated hair growth in animals. The current trial is to test the products safety in humans.
“Histogen’s clinical trial was designed to assess the safety of its product over a five month period,” Dr. Ziering said. “In addition to seeing no adverse reactions, we were delighted to see more hair, thicker hair shafts, and what appears to be the growth of completely new hair follicles in the areas that received the ReGenica treatment.”
The trial is ongoing but Histogen expects to release full results from this first clinical study in the first half of 2009.
There are hundreds of hair loss treatments and products currently available to the public but there remain only three which have the FDA’s tick of approval. Experimentation with products that are not clinically proven or supported by medical bodies may not only be a waste of time and money, but potentially unsafe. We will await further information regarding Histogen.