Someone from Histogen e-mailed me yesterday after reading the reader comments to my last post. I will not post this person’s name, exact job title or e-mail address here since some of this blog’s readers are nutjobs who will probably stalk the said person! The e-mail contents, however, are important and pasted below:
Thank you for mentioning Histogen and HSC on your hair loss blog. We appreciate your consideration of our product. I visited your blog today and noticed that there was some confusion about the trial photos included in Dr. Gail Naughton’s Stem Cell Summit presentation. I was hoping to clear this up with you and that you could disseminate the information to your readers.
3 clinical studies of HSC have been completed: a Pilot study, Phase I/II study, and a Physician Sponsored study with Dr. Ziering. As some of your readers pointed out, the photos from the Pilot study are from 2009. However, the photos from Phase I/II and Dr. Ziering’s study are more recent. In fact some of the photos from Dr. Ziering’s study were introduced for the first time at the 2016 Stem Cell Summit in Boston. Histogen continues to be focused on developing this revolutionary new treatment and looks forward to beginning the next stages of clinical trials.
It would be great if readers who post comments to this blog post maintain some civility in case this Histogen employee who e-mailed me comes back to read the comments. Pertinent questions might get answered if we are lucky.
Update:Kerastem’s website has been revamped and has before and after photos if you scroll down, as well as links to clinics outside the US (e.g., see Japan Kerastem Clinic) where the treatment is already available. Also, on July 28th, the company obtained conditional FDA approval to commence phase II clinical trials.
On this blog, I have discussed the relationship between hair cells and fat cells numerous times.
One thing missing in the above three posts was a private sector company working on a cure for hair loss based on using adipose (fat) tissue. That wait has now come to an end. Last week, a relatively new San Diego based company called Kerastem Technologies submitted a request to commence STYLE clinical trials in order to:
“Evaluate the safety and feasibility of the Celution and Puregraft Systems in the processing and preparation of an autologous fat graft enriched with adipose-derived regenerative cells (ADRCs) in the treatment of early alopecia androgenetica.”
The above link to the clinical trials page has a contact person’s e-mail address on there that I will not publish here. This contact person is Dr. Eric Daniels, Kerastem’s chief medical officer.
Note that adipose-derived stem cells (ADSCs) are a subset of adipose-derived regenerative cells (ADRCs).
FYI — A Kerastem company video is embedded at the bottom of this post.
Celution & Puregraft Systems
The Celution system is manufactured by a San Diego based company called Cytori Therapeutics. The US FDA approved and EU CE-Marked Puregraft system was also developed by Cytori, but divested in 2013 to Bimini Technologies. I recommend watching the Puregraft video on youtube. I am now starting to look at my body fat in a less negative way. Maybe it will end up being more useful than I thought!
Ken Washenik is Involved
One of the world’s most renowned hair loss researchers (that I have covered a few times on this blog) Dr. Ken Washenik is involved in this clinical trial via being the principle investigator. This adds significant credence to these trials, although it should be noted that Dr. Washenik has been overly optimistic about a hair loss cure in the past (e.g., see my post on Aderans’ Failure or read some of the overly optimistic time-frame related quotes by him in this 2004 article.
Bimini, Puregraft & Kerastem
It should be noted that Bimini, Puregraft and Kerastem are all interlinked, with Bimini seemingly the holding company. The founder and CEO of Puregraft, Bradford Conlan, is also the CEO of Kerastem and Bimini per his current Linkedin profile. For our analysis purposes, these three companies are one and the same.
Dr. Eric Daniels and Dr. Craig Ziering
I mentioned Kerastem’s chief medical Dr. Eric Daniels as the contact person for these trials earlier. Further research on him led to my finding that he presented a paper titled “Hair Follicle Stimulation by Stromal Vascular Fraction Enhanced Adipose Transplantation” in 2014 at an International Federation for Adipose Therapeutics and Science (IFATS) Conference. Although I could not find that paper online, google gave me a link to this useful thread [40 percent hair regrowth per early results!] that suggests that Dr. Craig Ziering was another author of that same paper. So now I should take Dr. Ziering and his work on stem cells more seriously in spite of the recent issues with his website. I wonder if he already has access to the tried and tested Celution and Puregraft systems, giving him a leg up on other hair doctors offering early stem cell treatments?
San Diego, a Biotech Hub
San Diego has become a hotbed of global biotechnology related research, and the hair loss world is no exception. Kerastem is the fourth (!) San Diego based company that is now listed in the world map of groundbreaking hair loss research work on this site. The other three are Histogen, Samumed and Sanford-Burnham.
Per the comments to this post and on various hair loss forums, it seems like some people are overly pessimistic about the timeline for ADSC and ADRC type treatments. Surgeons around the world are already treating patients with ADSC, AAPE and PRP. This kind of treatment will not take too long to come to fruition.