Stemson Therapeutics: Clinical Trials as Planned in January 2021? An Update

by Andre

A very Happy New Year to all our readers. We start 2021 with an in-depth look at the latest news regarding Stemson Therapeutics and their novel solution for hair loss involving stem cells. The 2018 medical firm shot to headlines back in summer 2019 with their breakthrough demonstration of hair grown using novel stem cell technology.

However, over 18 months later we ask, what’s the latest regarding this form of treatment, and when can we realistically expect it to begin to be offered to the patients?


The Breakthrough: Controlled Hair Growth

26th June 2019. In front of an audience at The International Society for Stem Cell Research in Illinois, Stemson Therapeutics demonstrated results of the first application of a stem cell treatment that had the potential to produce cosmetically appealing results, albeit in mice for the time being.

The application of stem cell treatment to generate hair growth itself wasn’t new, but controlling that hair growth to achieve an aesthetically pleasing result was.

Figure 1: A snippet from Stemon Therapeutic’s press release showing the sprout of well directed, stem cell generated hair growth

Stemson Therapeutics used what they called a “3D biodegradable scaffold” to help both the stem cells to embed themselves correctly within the dermal papilla, as well as to control the trajectory of each hair as it grew through the skin. The scaffold itself was made using the same biodegradable material as is currently used in dissolvable stitches.


How do Stem Cells help to solve hair loss?

Stem cells are a special type of cell found within the human body that are able to turn into many different tissue types ranging from muscle and liver cells, all the way to or nerve or brain cells.

There are 3 main types of Stem Cells that can be extracted or harvested from the human body:

  1. Embryonic Stem Cells taken from embryos (their usage has been surrounded by controversy because of this fact.) They are called ‘pluripotent’ stems cells as they are capable of going on to produce any tissue type
  2. Adult Stem Cells which come in two types:
    1. Specific Stem Cells exist in a particular tissue type (e.g. stem cells taken from the brain or lungs) and only produce multiple cells of the tissue from which they were taken
    2. Induced Pluripotent Stem Cells which, as the name vaguely suggests, have been changed in a lab to become more like embryonic stem cells and therefore pluripotent


Stemson Therapeutics’ method relies upon Induced Pluripotent Stem Cells, or IPSCs for short. These are stem cells that can be manipulated to produce any number of specific body tissue types.

In this case, IPSCs were used to produce dermal papilla cells which are cells found in the base of each individual hair follicle and are responsible for controlling the hair growth cycle as well as providing all the correct nutrients and environmental conditions in which hair can healthily grow.

By renewing the dermal papilla cells in the scalp with those produced by the aforementioned stem cell process, Stemson Therapeutics were able to grow new hair on the bodies of immunodeficient mice that had no body hair.

Figure 2: A graphic taken from Stemson Therapeutic’s website showing the lifecycle of stem cells and with that, the potential they offer to a multitude of medical conditions

Crudely put, the main issue with the latest technology for remedying hair loss, whether via Follicular Unit Transplantation (FUT) or Extraction (FUE), is the number of donor hairs available for transplant to the top of the scalp.

Stem Cell treatment would completely bypass this limit and provide an unlimited amount of new follicles that could be produced from just one extraction of a patient’s stem cells and with no risk of the body rejecting those new cells.

Stemson Therapeutic’s demonstration was clearly a promising development and lead many to hope that a true solution was finally achievable and at least marked on the horizon, but 18 months and one global pandemic later, how further forward are Stemson from bringing this treatment to market?


Investment, More Investment, and Team Development

The 2019 presentation was closely followed by a $3m investment from pharmaceutical giant Allergan, which saw Stemson included in it’s wider Medical Aesthetics Portfolio. Many saw this as a strong vote of confidence in both the significance of the potential solution that Stemson had developed, as well as the quality of the Stemson team itself.

It also meant that naturally, the access to both resources and expertise on offer to Stemson would significantly increase and that in of itself would increase the chances of R&D success.

September 2020 saw the completion of a $7.5m seed funding round((https://www.businesswire.com/news/home/20200916005288/en/Stemson-Therapeutics-Secures-7.5M-Seed-Financing-for-the-Development-of-Breakthrough-Hair-Regeneration-Therapy-to-Cure-Hair-Loss)), with venture capitalist fund Fortunis Capital coming onboard led by Sir Andrew Ross.

Fortunis specialise in investments that “support the positive evolution of society” through innovative solutions that “offer significant social or environmental benefit.” They described Stemon’s innovation as “game-changing” with an “experienced management team”. All sentiments we would strongly agree with.

The above funding, in part, was used to build out the already robust team at the company. From its 2018 founding by messsers Terskikh and Hamilton; with over 10 years experience in stem cell research and biotech/pharma businesses respectively, the company now stands at approximately 15 employees, 7 of whom sit solely in the R&D part of the business.

In late 2019, Dr. Cenk Sumen was brought onto the board, bringing with him over 10 years of experience in bringing stem cell treatments to readiness for mass-market manufacturing. A year later, Dr. Meghan Samberg joined to head up Stemonson’s R&D effort, bringing with her a multitude of clinical research experience in seed-stage companies.

Figure 3: The current 4 strong Executive Board


So what’s the wrap as of Q3 2020?

The bringing on of Fortunis Capital in September 2020 saw a Brexit focussed UK open up its doors to Stemson it looked to attract highly skilled labour and technology from around the globe. UK-based Fortunis announced they would be leading Stemson’s R&D capabilities in the country, offering Stemson the opportunity to both grow and mature its R&D knowledgebase in an otherwise inaccessible way.

So there has been no explicit mention of the technological progress of the treatment since mid-2019, however, from what we can infer from headlines surrounding the business as a whole, things appear to be moving in the right direction for Stemson Therapeutics and votes confidence from institutional and pharmaceutical backers gives weight to their solution.


Is A Solution in Sight?

The key question on everyone’s’ minds is when might this solution become widely available, and this is the million-dollar question. Aside from treating some forms of cancer and blood diseases, stem cell treatments as a category are still largely in their infancy.

With typical routes to market of clinically tried and tested treatments still taking between 5-10 years on average, given that Stemson Therapeutics isn’t yet at that stage, realistic timelines could be at least 6 -7 years from now, assuming all goes well, before a solution is available at your local hair transplant clinic.

As of the June 2019 presentation, Co-Founder Geoff Hamilton estimated human clinical trials beginning “a year and half” later, making that January 2021. We await any news from the company whether that remains a viable target or not, but given the Coronavirus pandemic that has gripped the world for much of the time since the 2019 meeting, timelines are likely to have been affected in some way.

We wait with baited breath and hope that progress continues successful in the meantime at the company.

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