My meeting with Dr. Ken Washenik was delayed and unfortunately both of us had to quickly attend another presentation shortly after. We segwayed during our converation, badly, lol. But that's not to say I didn't get any information from Dr. Washenik. What happened was that we first talked about our upbringing and history with hair loss, we talked about what we use, and I mentioned some of the experimentals I'm on. This topic actually lasted a while. Due to this and the short amount of time until the next presentation that day, I wasn't able to cover a lot of ground.
I did take notes, but because the conversation was relatively short in regards to kerastem, I didn't have many, AND because we sorta rushed the last bit about kerastem, I couldnt keep up with note talking, questions AND answers. So, they were limited. Cherry on top: I LOST MY NOTES!
But, he did mention Kerastem is already available (I'm pretty sure). He mentioned ARI is up for sale (afaik, Aderans owned ARI) and mentioned the IP is cheap but running further trials would be expensive. So, it's not like the tech is completely finished.
After that, he mentioned he's on the board of directors (I think) at Follica and, like Dr. Cotsarelis, couldn't comment on development of Follica.
In regards to Kerastem, here's some extra info:
They're doing the procedure in Japan and Switzerland now. Spain will be available in shortly. So it's commercially available now.
I'm not sure if it's IIa or IIb. The initial test, as mentioned on kerastem.com, sites a 6 user trial with 100% response rate. I believe there is a 21 person trial in the UK and Japan ('results support the safety and feasibility of the procedure'), which suggests this current test is IIb.
There are two parts to the Kerastem procedure. 1. Injection of fat cells 2. Injection of ADRCs (adipose derived regenerative cells). The ADRCs are prepared from the same fat cells using a proprietary, trademarked method that Kerastem calls 'Celution'. These cells trigger protein pathways and hormonal behaviour. The two steps are both equally important, working in conjunction 50/50.
Normally, an autologous procedure (moving something from your own body back into your own body) is not that heavily regulated since the risks are minimum. However, since the 'Celution' method of prepping the ADRC's purifies the cells, the FDA has decided they are no longer 'autologous' since the cells have changed. Kerastem has to jump through a ton of hoops in the US because of this.
No word on when commercially available in the US. All data should be gathered by Spring of 2017, since the trial goes for a year. At that point they'll jump into phase III, which means more time. However, they will have published a ton more data on their procedure, allowing us to make a more educated decision on whether or not we all want to fly to Japan or Switzerland and spend money.
Many thanks to Dr. Ken Washenik for taking time out of his schedule to meet with me, as well as Dr. Eric Daniels for setting up our meeting!
