Approximately 528 million people worldwide suffered from osteoarthritis in 2019, an increase of 113% from 1990. According to a new study published by the Lancet Rheumatology, the most prevalent kind of arthritis, osteoarthritis, will affect approximately 1 billion people by 2050. Currently, 15% of individuals aged 30 and older experience osteoarthritis.
Osteoarthritis (OA) is a chronic joint illness that eventually results in pain and limb dysfunction, as it is defined by the loss of joint cartilage, thickening of the joint capsule, and the growth of new bone surrounding the joint. Osteoarthritis can be extremely painful and drastically reduces the quality of life for patients suffering from this disease. Osteoarthritis has no treatment for the moment, and it is currently impossible to stop the disease’s progression.
To provide a solution to this urgent problem, a startup based out of Hungary and the UK called StemcellX is working at the intersection of stem cells, regenerative medicine, and genetics.
How does their technology work?
StemcellX is developing mesenchymal stem cell-based products for the treatment of osteoarthritis that are safe to use, readily available and provide long-term relief from pain and inflammation. Their strategic focus is on humans, however, they are currently working on animals as a natural early adopter market with lower regulatory barriers and an important proof-of-concept for the development of a therapy for human OA.
Currently, their technological platform has been used successfully in several animal species; their stem cell product has been demonstrated to treat osteoarthritis in dogs very successfully. An ethical and scalable production methodology is employed, utilizing allogeneic mesenchymal stem cells that are derived from healthy donors.
Company foundation and main challenges
StemcellX was founded in 2016 by Endre Kiss-Tóth (CEO) and Lajos Haracska (CSO). The team conducted some of the largest published research trials for the use of stem cells in dogs osteoarthritis and in these studies, they found that their treatment was incredibly effective and long-lasting.
“It really gave us the idea to try to commercialize this and develop it fully as a medicinal product”-commented Prof. Kiss-Tóth during the interview.
According to Prof. Kiss-Tóth, several challenges pop up during their journey, but the most difficult ones have been the fact that stem cell therapy is a novel and until recently, a largely unregulated area of product development, as well as finding investors:
“It is a new area of product development, and because of that, regulations are much less established than they would be for more traditional small molecule drug development, so in one hand that makes our life a bit more complicated because we have less of a guidance, but it also enables us to interact with the European Regulator and essentially shape the regulatory framework during these communications. So it’s both a challenge and an opportunity. The second challenge for us has been to find investors to bring equity investment into the company to complete our R&D and also support our market entry. We found that most investors had no previous experience in the veterinary health sector – our short-term market focus – and because of that it’s much more difficult to engage and bring them on board”- explained Prof. Kiss-Tóth.
Projects and future plans
StemcellX focuses on humans, but firstly they have developed stem cell treatments for osteoarthritis for veterinary use. This will enable them to mature the technology and take it to the next stage.
“Most of the work we have done was to develop this technology as a platform and apply it to the treatment of dogs, so we have done the vast majority of the R&D and we are hoping to have regulatory trials soon to complete the development”- said Prof. Kiss-Tóth.
The company has also started to apply their skills and technologies to benefit animals closely related to humans. Their most notable one was the treatment of Liesel, the gorilla in the Budapest Zoo in August 2023. This elderly gorilla was suffering from osteoarthritis, and the Zoo gave StemcellX a fat tissue sample from another younger female. From that, they produced stem cells which were suitable for injection, then the medical team examined the patient to identify the affected joints and injected these cells into the most affected joints. Checkups (up-to 4 months after the treatment currently) are indicating that their therapy is working well, the gorilla is much better and seems to be free of symptoms. However, their objectives go far beyond this:
“Developing this technology as a platform to formulate stem cells enables us to rapidly translate our techniques for human product development. Our background lets us fast-track and achieve milestones much quicker than somebody who comes fresh and starts developing human only”- stated Prof. Kiss-Tóth.
A very promising future lies ahead:
“Our first product will reach the market in the next three years or so with the first highly scalable stem cell treatment for dogs. Also, we’ll be able to provide treatments for other animals in other settings, and use this knowledge to fast-track human development. We expect to have a significant market penetration in 5 years and be doing our first human clinical trial”- explained Prof. Kiss-Tóth.
StemcellX and Strata’s collaboration
Prof. Kiss-Tóth considers the EIC a fantastic scheme because it enables SMEs to have a bottom-up approach to promote innovative ideas, compete for funding and have a very open field for innovative solutions.
“It’s also true that applying for such competitive schemes requires not only founders and experts who are proficient in their projects and have a business plan to market, but also consultation skills and this specialist knowledge to formulate our plans in a way that makes it compelling. Strata has added tremendous value to help us with that sort of translation: we had the project planned, but actually to present it in the most compelling manner is something that has been fantastic”- explained Prof. Kiss-Tóth.
StemcellX started the EIC Accelerator on their own before meeting Strata: they did Step 1 by themselves, but they found it really challenging to have a fully prepared application for Step 2, and finding Strata came at the right time for them:
“It’s a very professional, very very engaged team and the efficiency was just incredible. It is something that we felt from day one until today, that everybody knew exactly what the process was and how to support us in the most effective way and what the next steps should be and there was always a clear roadmap presented to us which I think is really fantastic”- concluded Prof. Kiss-Tóth.
