Category Archives: Claire Higgins

HairClone to Offer Cell Expansion Service by 2025

HairClone Follicle Banking
HairClone Follicle Banking.

I first covered UK based HairClone in 2016 in this very post (original version at the bottom). Then I interviewed the company’s accomplished CEO Dr. Paul Kemp several times.

Note that Mr. Kemp was previously CEO of Intercytex and has decades of experience in the regenerative medicine and hair space.

I wrote another post on HairClone’s hair follicle banking service in 2019 and updated it in 2021.

HairClone in Guardian and New Scientist

Update: October 16, 2023

  • I missed this interesting update from HairClone in Guardian on October 1 (h/t “Ben”). Around 200 patients have banked their hair follicles with the company so far. Key quote:

“The company is in the process of establishing quality controls that will allow it to manufacture cells to clinical standards. At that point (the company is hoping that will be within the next 12-18 months) doctors will be able to offer it on an experimental basis to select patients.”

So the end of 2024 is a best case scenario. Based on past delays, I am changing the wording in the title of this post to 2025.

  • Also of note, HairClone was also covered in New Scientist Magazine on September 26, 2023. It is paywalled, but a summary can be read here. Perhaps they really are getting very serious about the time frame and hence all the publicity.

Update: March 9, 2023

Last week, one of our readers mentioned that HairClone had updated its website. I contacted Dr. Kemp and he confirmed that the refreshed site was launched on February 27th, 2023. And they also have a new logo. Moreover, the company plans to start its delayed cell expansion service no later than 2024.

HairClone to Start Cell Expansion Service by 2024

In my prior update from 2021, I mentioned HairClone’s goal of commencing its cell expansion service in 2022. However, this was delayed in the aftermath of Covid and fundraising related issues. Several days ago, Dr. Paul Kemp sent me an update and I am pasting his e-mail below:

“Sorry for not replying sooner but I have just returned from annual leave. Yes we have freshened up the website and created a new logo that was inspired by our goal of rebuilding miniaturizing hair follicles. It was launched Feb 27th.

Our banking service continues to increase and we now have had 3 years of successive growth. We have also shown that our cryopreservation technology, as well as preserving the Dermal Papilla (DP) cells that we will use in the treatment we are developing, is also able to cryopreserve the other cell types from the hair follicle such as melanocytes, epithelial cells and bulge stem cells which could be used in other Regenerative Medicine therapies.

Though we are focusing solely on androgenic alopecia at this time, the follicles we are banking remain the property of the patients so this is a valuable way that patients could store considerable numbers of various cell types in a simple outpatient surgical procedure.

As always, we are re-investing revenues from banking to advance the therapy but are still limited by our ability to bring our technology to the clinic by our funding of the GMP manufacturing process needed to use the DP cells in the clinic.

We have developed an effective and reproducible system to increase the number of DP cells over 1,000 fold and have been able to carry out most of the technical transfer stages of this process to a licensed contract manufacturing facility. But we need additional funds in order to complete this technical transfer and enable the manufacturing facility to produce cells for clinical use.

We are looking to increase the number of Banking Associate Clinics that we work with both in the Americas as well as Europe and Asia and we are working to raise new equity funding in 2023. Our aim is to obtain the funds needed and start offering our cell expansion service no later than 2024.

Update: October 15, 2021

I always assumed that HairClone’s actual hair cloning or hair multiplication procedure was still years away. They have yet to even start human clinical trials. However, when it comes to autologous hair cell multiplication and transplantation, the UK has less stringent guidelines when it comes to testing in humans. Clinicians can offer unlicensed procedures prior to clinical trials. Japan also has some similar favorable regulations.

What an incredible surprise to then find this encouraging new below interview of Dr. Paul Kemp! He is one of the keynote speakers at the upcoming ISHRS 2021 conference. His presentation will be titled:

“The Evolution of the Promise of Hair Cloning: How Hair Cell Cloning will Fit Into Your Practice.”

HairClone will offer its cell expansion hair multiplication services on a select basis in certain clinics in the UK starting in early 2022. Dr. Kemp has consulted with regulators and they are very supportive of this step. It is a way to ensure that future expensive and lengthy clinical trials have a much greater chance of success.

“What we are planning to do early next year is offer a cell expansion service.”

— Above is a Paul Kemp quote at 15.:50 in the below video.

September 8, 2016

During the past few months, there have been a few new companies entering the hair regeneration sector. Today, I learnt about yet another new entrant into the field named HairClone that warranted its own post. As yet, I do not consider HairClone anywhere near as important as the established entities such as the RIKEN/Kyocera/Tsuji partnership (Japan); or the Shiseido/Replicel partnership (Japan).

HairClone

I will briefly analyze HairClone via its positives and negatives:

Positives

  • The renowned and widely respected researcher Dr. Claire Higgins joined HairClone’s advisory board on August 30th, 2016.
  • HairClone will be hiring more scientific advisers besides Dr. Claire Higgins in the near future. Would be great if they tried to get Dr. Roland Lauster into the team.
  • A recent Tweet suggests monthly update meetings with PhD students.
  • HairClone has devised a unique and creative strategy to get funding that includes: crowdfunding; giving people who fund the company’s research preference when the actual treatment comes out; allowing investment in equity; offering leading hair transplant clinics around the world membership opportunities; and most interesting of all, hair follicle banking and storage.

Negatives

  • By far the biggest negative is that this is still way too early in the game and who knows when trials will commence, and whether the company will succeed with its dermal papilla focused cloning technology in the first place. Or even if they manage to get sufficient funding.
  • Related to the above, when Solomon interviewed Dr. Claire Higgins earlier this year, she generally sounded pessimistic about new treatments and said the following about cloning. Update: Solomon corrected me in the comments and said she was only talking about cell injections. But I think she sounded pessimistic about the hair cloning time-frame in the whole interview:

“I think the future (but it’s not in 4 years or 5 years away, it’s like in 20 years) is to promote direct conversion of fibroblasts into papillae. But something like this will take decades. We don’t know how to do that yet.”

I am hoping that Dr. Higgins will change her prediction to 10 years if her lab and research work gets significantly more resources as a result of HairClone. Thankfully, she said that she was not exactly sure about Dr. Tsuji’s work. Neither did she list Shiseido’s trials in Japan in her list of ongoing trial examples. So maybe she is just entirely focused on her own work and not following others too much?

Twenty years would be too big a gamble to invest in a company such as HairClone. I hope Dr. Bessam Farjo has other ideas and is hoping for much faster completion of clinical trials. And hopefully he is not only relying on Dr. Higgins’ dermal papilla related work.

Ruxolitinib and Tofacitinib Could Also Regrow Hair in AGA

Last Year

Last year, by far the biggest news of the year involved two likely cures for alopecia areata (AA) in humans.  One was the arthritis drug tocafitinib and the other was the cancer drug ruxolitinib.  Both drugs are classified as Janus kinase (JAK) inhibitors, and it is likely that many other drugs from this family will lead to similar results when it comes to hair regrowth.  If you read my two main posts on this subject from last year (see here and here), it should be quite obvious how exciting the news was based on the large-scale global media coverage at the time (and of course the miraculous before and after human scalp photos instead of the usual mice photos).

Unfortunately, the vast majority of men (and many women too) who have hair loss suffer from androgenic alopecia, also known as male pattern baldness (MPB). There are probably 100 times as many people who suffer from MPB as there are who suffer from alopecia areata.  So the big news of last year was only useful to 1 percent of hair loss sufferers, at least for the time being.

While many people (including the famous Dr. George Cotsarelis) dismissed the potential for JAK inhibitors to work on people who have androgenic alopecia, I was not so pessimistic.  In my posts from last year, I mentioned that MPB probably also had an immune system attack/inflammatory component to it (and JAK inhibitors seem to cure alopecia areata via stopping the immune system from attacking the follicles).  My theory was partly due to the fact that I and numerous others get a lot of itching and dandruff while losing hair (especially if not using shampoos such as Nizoral).  I was therefore very surprised that Dr. Cotsarelis was dismissing these developments so fast.  It should be noted that all of his decades of work and numerous patents could go down the drain if JAK inhibitors were to cure MPB in humans without any major side effects, since this is one rare area of hair loss research that Dr. Cotsarelis has never touched.

Strangely enough, the two teams that discovered the cure for alopecia areata last year were both based in New York.  One was led by Dr. Angela Christiano and the other was led by Dr. Brett King. The latter has credited the former with being the pioneer in this work.

My biggest reason for keeping faith in the potential of JAK inhibitors to also work on people with male pattern hair loss was the Bald Truth interview that Spencer Kobren did with Dr. Brett King.  In the video, Dr. King mentions that a topical formulation of Tofacitinib would likely be tested on patients with Androgenic Alopecia.  He clearly felt that JAK inhibitors could perhaps work on MPB patients too.  If I had to rate the chances of a hair loss cure for MPB arising from JAK inhibitors after that interview from last year, I would have said 3/10.  After the below groundbreaking developments of today, I will raise my rating to 5/10.  The one big issue is whether these drugs can regrow hair that has been lost for more than several years. Also an issue is long-term side effects, but so far the oral JAK inhibitors do not seem to have caused any deaths, and the topical version of those inhibitors will likely lead to even fewer side effects.

Today

Lo and behold, today Dr. Angela Christiano and her team published some findings (FULL TEXT AVAILABLE) that suggest a better than negligible chance of JAK inhibitors also working to treat androgenic alopecia. This time, they managed to grow hair on rats via a topical formulation of both Ruxolitinib and Tofacitinib.   Below are the stunning pictures, albeit in mice this time (although it should be noted that they also grafted human hair onto the mice and achieved great results):

Image below from this Daily Mail article:

 

Ruxolitinib and Tofacitinib Hair Growth

Some key quotes from Dr. Christiano per various articles from today:

“Male pattern hair loss follicles are stuck in the same state where these drugs seem to work.”

“What we’ve found is promising, though we haven’t yet shown it is effective for male pattern baldness.”

“JAK inhibitors seem to be among the very few number of compounds that produce hair growth very soon after their application.”

“But applying such drugs topically would be far safer.”

“Delivering it on the skin also seems to get more of the drug into the hair follicles.”

“Some topical agents induce tufts of hair here and there after a few weeks, but very few have such a powerful and rapid-acting effect.”

JAK Inhibitors Might Directly Affect Hair Follicles

The most interesting part of these experiments was that the mice grew more hair when the drug was applied topically to their skin versus when it was given to them to take internally.  The research team thinks that this implies that JAK inhibitors might have a direct effect on hair follicles, in addition to the already known effect of inhibiting the immune attack.  It should be noted that the precise terminology for this whole mechanism is “pharmacological inhibition of the JAK-STAT pathway/signaling”, with the STAT standing for “signal transducer and activator of transcription .”

JAK Inhibitors and Dermal Papilla Cells

I also found it interesting that the full published study has the following quote in the Abstract:

“We show that JAK inhibition regulates the activation of key hair follicle populations such as the hair germ and improves the inductivity of cultured human dermal papilla cells by controlling a molecular signature enriched in intact, fully inductive dermal papillae.”

A huge amount of hair loss research entails dermal papilla cells.  I am not a scientist, but it seems like the above findings could also have ramifications for companies involved in 3D culturing of dermal papilla cells.  In fact one of the co-authors of today’s groundbreaking paper is renowned hair loss researcher Dr. Claire Higgins, who has done quite a bit of work on 3D culturing of dermal papilla cells.

Vixen Pharmaceuticals

According to the NBC article on this development:

Columbia University has filed patent applications relating to the discoveries reported in this paper, which are being commercialized through Vixen Pharmaceuticals, Inc., of which Dr. Christiano is a founder.

This is interesting since some months ago I mentioned the fact that Dr. Christiano was supposedly starting a new company named “Rapunzel”.  Perhaps she will have two companies devoted to curing hair loss: one for pharmaceuticals and one for work related to hair cloning and hair multiplication (i.e., cell culturing, stem cells etc…)?

I find this development encouraging since it makes more sense for Dr. Christiano to start a company devoted to this treatment only if she feels there could be at least some benefit to people suffering from MPB.  Otherwise, she only has a market of 1 percent of balding people who have alopecia areata, and even that market would be split with other companies and doctors such as Dr. King that might make their own topical version of a different JAK inhibitor.

Videos

—  The video from CBS does not embed very well in correct size, but is worth watching.

— Also see the video from Columbia University.