Hair Loss Cure 2020

I first covered UK-based HairClone in 2016. Later in the same year, HairClone’s very friendly CEO Dr. Paul Kemp kindly answered a number of reader questions.

Although Dr. Kemp has since been in touch with me, I am reluctant to write more frequent posts on HairClone. I do not want to repeat follicle banking related news unless there is a groundbreaking development in actual hair multiplication. Dr. Kemp was formerly the CEO of Intercytex. I hope that he uses his past experiences to prevent another disappointment for us hair loss sufferers.

Update: May 21, 2021

HairClone, Claire Higgins and Hair Research PhD

HairClone and Dr. Claire Higgins are partnering to sponsor one PhD student for a hair research related opportunity at Imperial College London. A stipend of 18,000 British Pounds will be provided and the program begins in the 2021/2022 year. Besides Dr. Higgins, the student will also be mentored by Dr. Sylvain Ladame.

According to the announcement, this “advanced therapeutics” related research will consist of two parts:

Develop a microneedle device for the delivery of reprogrammed dermal papilla cells to miniaturized alopecic hair follicles.
Use in-depth computational analysis and in vitro hair follicle modeling. The purpose of this will be to understand the mode of action by which papilla cells rejuvenate hair follicles. And in the process, reverse androgenetic alopecia (aka male pattern baldness).

While it is great to see this initiative, it also means that the actual hair multiplication (or cloning) is still a few years away. In any event, I am glad that HairClone is still focusing on an ultimate goal beyond hair follicle banking.

August 4, 2019

HairClone Begins Follicle Banking

It seems like HairClone has not disbanded or gone silent, but is moving forward full steam. The company is starting its follicle banking service after earlier this week getting UK government approval. In fact the company will be the world’s first ever hair follicle banking system. Press release: follicle banking.

Edit: In May 2021, a South Korean company named Han Bio also supposedly started hair follicle banking services.

HairClone Follicle Banking. — HairClone’s Hair Follicle Banking Process.

The logic behind banking your currently healthy hair follicles is similar to the logic behind banking young sperm, of your young eggs, or even newborn umbilical cord blood banking.

Banking at the earliest opportunity “stops the clock” on young hair follicles from ageing. The dermal papilla cells will then theoretically be more active and “youthful” when the hair multiplication technology is available in future.

Both males and females over age 18 will be able to have around 50 follicle units extracted, cryopreserved and stored for future use (when hair multiplication or cloning type treatments are available). Cryopreservation and storage of hair follicles at -150C essentially “stops the clock” when it comes to further hair loss, thinning or miniaturization.

Dr. Paul Kemp’s Recent E-mail

Dear HLC2020 Admin,

It has been some months since we last chatted, but I just wanted to let you know that we have been working hard. We have now been authorized by the UK’s Human Tissue Authority (HTA) to begin to bank cryopreserved follicles. In order to gain this approval, we had to carry out extensive validation studies to show that we could:

Reproducibly extract human follicles.
Cryopreserve them.
Ship, test and thaw the follicles.
Extract viable cells that could be culture expanded.

We first submitted the license application in January and then there were a series of questions. Some of these needed additional work, but the end result is an incredibly well understood robust process.

The HTA stress that this does not authorize or approve treatment and gaining that approval is the next stage in our strategy. We are all set to develop the GMP validation data for culture expanded follicle cells and just need to raise the funds to do so. As you know, we tried to do this through crowdfunding, but unfortunately weren’t successful. So we are looking at alternative funding sources. This has given a significant delay to our original timelines.

Banking will be available through our clinical partners and banking associates who will be licensed procurement centers and we plan to increase the number of these partners and associates over the coming months.

Cryopreservation

Cryopreservation and follicle banking is just the first step in the process. Important elements to note are:

It will be available to both men and women.
Banking will allow multiple treatments from one initial surgery.
Banking at the earliest possible stage “stops the clock” on further ageing of the cells.
Since patients with banked follicles have already undergone the surgery step, they will be first in line for cell expansion when treatments are authorized.
The follicles remain the property of the patient so could be used in other cell based treatments if the patient chooes so down the road.

The next stage is to work with our clinical partners to develop a system to rebuild miniaturizing follicles. Follicular neogenesis is also an interest of ours. We are carrying out some work on this, but our first goal will be to rescue a patient’s natural hairs. As all patients are unique, we envision that this could also be used in the future in combination with hair transplants.

I have attached a press release that provides more information and please don’t hesitate to contact me if you have questions.

Paul Kemp PhD
Co-Founder, Chief Executive Director

www.HairClone.me
@HairClone
#HairClone

Update: May 6, 2021

Disappointing Results from Follicum FOL-005 Phase 2 Trial

Follicum just released top-line results of their Phase IIa study of FOL-005 for the treatment of hair loss. The results are disappointing.

“In those treated with the highest dose of FOL-005 studied, hair growth increased by 6.6 hair/cm2, compared to 5.6 hair/cm2 in the placebo group.”

The difference between the treated group and the placebo group was not significant. While I never expecting this treatment to be anything much better than Minoxidil, I was still hopeful. Follicum has been extremely professional and fast in its trial progression and updates since I first started covering them in 2015.

In any case, it is also rare for a company in the hair loss world to give us disappointing news in an honest manner. A number of other hair loss companies in the past (and present?) tend to extend their importance beyond a decade. Then they ultimately fold or go out of business.

Update: October 9, 2020 — Follicum has completed its over 200 patient enrollment in its Phase IIa trials for FOL-005. Treatment will finish in all patients at the end of January 2021. Results are expected to be announced in Spring 2021. So far, no adverse effects and no patients have discontinued with their participation in the trials.

Follicum Trials to Restart

June 8, 2020

Follicum chief business office Mr. Gunnar Gårdemyr just sent an encouraging e-mail, part of which I am pasting below. Note that these Phase IIa trials entail topical application of FOL-005. In two prior trials, FOL-005 was administered via intradermal injections.

“Some good news. We will restart the clinical Phase IIa study with a cream-like formulation of FOL-005 this month, following a pause due to the Covid-19 pandemic. To increase the recruitment rate, we have contracted a third study centre. The study comprises approximately 200 male patients with hair loss who are treated daily for four months with the newly developed formulation of FOL-005 or placebo.

The study is being conducted at the Clinical Research Center for Hair and Skin Science (“CRC”) in Berlin; proDERM in Hamburg; and the new center, CentroDerm in Wuppertal. The patients themselves will apply a cream with three different strengths of FOL-005 or placebo in the scalp, once daily in the evening. The study is expected to be completed and the results communicated in spring 2021.”

February 1, 2020

I have written about Sweden-based Follicum and its FOL-005 hair growth product numerous times. Several days ago, Follicum’s CEO Jan Alenfall announced that German authorities have granted the company approval to commence Phase IIa clinical trials for FOL-005. The go-ahead was granted by the German Medicines Agency (BfArM) and the German Ethics Committee.

Also see this recent article titled: “The rise of therapeutic peptides: Follicum at the forefront.” Key quote:

“Peptide-based drug candidates are more likely to reach the market compared to small molecule drug candidates.”

Follicum Phase IIa Trials in Berlin and Hamburg

The trial will comprise about 200 patients who will be treated with topical FOL-005 or placebo daily for 4 months. Results will be released in the fourth quarter of 2020. The upcoming phase IIa study will investigate the safety, efficacy and response to a topical formulation of FOL-005. Note that in 2018, an injectable version of FOL-005 produced a good safety profile and hair growth results.

The press release states that patient recruitment will start soon. I contacted Follicum to see if any of this blog’s European readers would be able to volunteer as test candidates. However, the company’s chief business office Mr. Gunnar Gårdemyr replied in the negative. He said that all 200 test male patients for the trials have now been recruited and are from Germany.

The trials will be conducted at:

Charité Clinical Research Center for Hair and Skin Science (“CRC”) in Berlin. A highly reputable institute that I have covered in the past on this blog.
Hamburg-based proDERM, which just celebrated its 25-year anniversary. The have an interesting website section on hair care and hair removal.

About FOL-005

According to Follicum, FOL-005 is a proprietary peptide. Its development was based on research involving the human protein osteopontin. FOL-005 is a shorter sequence of osteopontin. The sequence has been slightly modified, but is still based on natural amino acids according to Follicum.

HairClone Follicle Banking and Hair Regrowth