I had the opportunity to speak with Paul Kemp PhD this week about his new hair growth venture, HairClone. Paul shared a brief presentation with me about the concepts and business plan that HairClone is based upon. I can say I am genuinely impressed, there is evolution here. An experienced medical and business team, elements of crowd funding, and an ideal medical development system are all part of the formula that makes HairClone.
The formula that HairClone is based upon could be described as “innovation.” The true innovation of HairClone is not so much the treatment itself, as others are working on cellular treatments, but more so the format in which HairClone will develop their treatment. They are calling the process “Medical Innovation” and are bringing together groups of patients and clinicians to co-develop the treatment. This is similar to the process that hair transplantation has followed. In hair transplantation, surgeons began with hair plugs, then strip surgeries, and eventually FUE surgery was developed and refined with the patients to the benefit of the patient. HairClone plans to integrate that process of ‘treatment practice of medicine’ with ‘scientific advances’ into hair cloning treatments. From HairClone’s website:
“The basic elements of hair cloning involves obtaining a patient’s follicles, dissembling them to obtain the required cells, expanding these cells in culture and then re-implanting them in the patient. Some of these stages are already understood and HairClone will optimise each in parallel both in the laboratory and the clinic in order to develop an effective therapy.”
Sounds brilliant, but how is it possible? Paul has worked extensively in the US and UK and feels that this process of Medical Innovation for hair cloning can best be carried out in the UK. In the UK a doctor may decide under his or her own judgement that a treatment is suitable for their patient and administer that treatment to their patient. There are regulatory criteria that the treatment must meet in order to be used under the regulator’s so called “Specials” exemption. The biggest factor is that the decision to use the treatment has to come solely from the doctor and the company developing the treatment must not market their treatments to doctors or make any claims about said treatments.
In other words, through Specials the doctors are empowered to utilize a treatment that under their best judgement they believe to be safe, and believe is likely to be effective for their patients when a licensed alternative treatment is not available. When first hearing about this system used in the UK I was surprised and also impressed. It is a modernized development and I hope that other countries would take a look at a system like this and consider it for their own use.
Because of this Specials system, HairClone isn’t going to need to develop their treatment in isolation, carrying out clinical trials for several years and then launching the treatment onto the market. They will make use of an iterative approach, constantly learning and adapting through the tried, tested, and successful approach of Medical Innovation.
Another innovative facet that really stood out to me from the slideshow is the community based approach HairClone is taking to create their solution. The HairClone treatment is aimed to work in conjunction with hair transplantation. Said treatment could potentially be useful for people who were not previously a good candidate for hair transplant surgery and especially younger patients who would have traditionally not been good candidates for surgery due to the uncertainty of their future hair loss. I know some of you are getting ready to ask, No, this does not mean that HairClone is only going to be used during a hair transplant surgery. What it means is that this treatment is aimed to be conducted in offices already practicing hair transplant surgery. I like this because I feel that it removes the apprehension that a hair transplant surgeon might have towards a cellular hair growth treatment and encourages cohesion and optimism.
Also, as you’ve heard before HairClone is looking into both equity based and reward based crowdfunding to help finance their developments. This is something that myself and many others have been calling for in hair growth research for quite some time. It would be a wonderful sight to see the world come together and be successful in supporting a new treatment that is able to restore hair in a graceful manner.
HairClone aims to begin follicle banking for patients in the UK in 1st half 2017 and transplanting cellular treatments in 2nd half 2017, though this is dependent upon HairClone getting sufficient investments to carry out their development plan.
Commentary for the Enthusiasts
I know that even at this stage inquiring minds are going to want more details about how HairClone aims to get it done. I did have a brief segment at the end of the presentation to ask Paul a few questions that I thought the readers of this site might ask. Here’s a little more background info on how HairClone got started and how it may work out:
FT: What was the deciding factor that made you want to get back into hair growth research and launch HairClone?
Paul: Hair research has been in the back of my mind since the program at Intercytex ended prematurely due to a lack of funding. The paper by Claire Higgins et al in 2013 really peaked my interest and got me back into thinking about this (hair regeneration). I spoke to Vincent Ronfard about the paper and we thought “let’s have another look at it.” I then had a discussion with Dr.s Bessam and Nilofer Farjo about the subject and they said that they still get inquiries all the time from patients about hair cloning treatments. The Dr.s said they were interested in the new project, but instead of just participating in the clinical trial, this time they wanted to be involved from day one in the development.
FT: Is the 50 hair follicles via FUE planned to be enough for a lifetime of HairClone treatments for a person?
Paul: The short answer is that the process is still iterative at this point. We estimate that a person with hair loss loses about 50,000 hairs over the course of their life. In the culturing process we usually get about 10X the amount of cells at each of three passages, so a 1,000 fold increase in total. The theory that we have at this point is that from 50 hairs we’d get about 50,000 hair cells. Whether this would be turning vellus hairs back into terminal hairs or generating new hair follicles we don’t know at this stage. All of this is estimated for now, but of course it is possible to go back and get more FUE at a later point if necessary. What we don’t want to do is harvest many more follicles than we need from a patient.
FT: Do you plan on using a 3D culturing system for this treatment?
Paul: At this point we still don’t know. There are many different culturing options, including 3D culturing, that are available and through our research we intend to find the one that works the best. The techniques used by Claire Higgins give us the tools to rapidly determine which system works best before we use the cells in the clinic. This process will be supported by our follicle banking system so that when, as we are hoping, the culturing system improves we would then be able to utilize the hair follicles that are banked and create cultures using the new culturing system.
FT: Thank you Paul for sharing this information for the readers of Follicle Thought.