MesoCellA-Ortho has been developed in accordance with pharmaceutical legislation, the European Medicines Agency's (EMA) guidelines, and the European Pharmacopoeia. It has been classified as a “tissue engineering product” by the EMA's Committee for Advanced Therapies, and the stages of its production have been approved by Polish legal institutions, including the Ministry of Health, the National Centre for Tissue and Cell Banking, and the Main Pharmaceutical Inspectorate. MesoCellA-Ortho product has undergone comprehensive characterisation of its biological properties in a series of in vitro and in vivo studies, forming the basis for the registration of the clinical trial.
Nearly 200 patients at the Galen-Ortopedia medical centre in Bieruń participated in a phase I/II clinical trial (NCT05081921) involving MesoCellA-Ortho, which was the largest study of its kind in Poland and was completed in 2024. The trial confirmed the safety and efficacy of MesoCellA-Ortho. During the trial, Prof. Krzysztof Ficek (Principal Investigator) applied an innovative approach to preparing patients for the administration of the cell-based medicinal product and for rehabilitation afterwards, contributing to the innovation and effectiveness of the strategy developed for treating OA patients. This approach enabled the selection of patients with specific clinical parameters who may benefit most from MesoCellA-Ortho therapy (i.e. the group of so-called responders).
The clinical trial was conducted in cooperation with the following:
- Galen-Ortopedia in Bieruń
- Tissue and Cell Bank at the Department of Cell Biology, Faculty of Biochemistry, Biophysics and Biotechnology, Jagiellonian University in Krakow
- Angelius Cell Bank in Katowice
- ATMP manufacturing site- Tissue and Cell Bank, Department of Transplantation, Institute of Pediatrics, Faculty of Medicine, Jagiellonian University Medical College in Krakow
- CRO- KCRI company.
The inventors of MesoCellA-Ortho are:
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Prof. Ewa Zuba-Surma, PhD, DSc
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Dr. Anna Łabędź-Masłowska, PhD
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Prof. Krzysztof Ficek, MD, PhD (Galen-Ortopedia in Bieruń)
The project was funded by the National Centre for Research and Development (NCBR) in Poland as part of the STRATEGMED III programme (grant no. STRATEGMED3/303570/7/NCBR/2017).
The composition and production method of MesoCellA-Ortho are both the subject of patent applications. MesoCellA-Ortho is currently at Implementation Readiness Level 9 (TLR9). The inventors are seeking financing for the next stages of product commercialisation and marketing authorisation.
Further information on MesoCellA-Ortho
1. A broadcast about the success of Prof. Ewa Zuby-Surma's Stem Cell Team, entitled “Revolution in the treatment of osteoarthritis”, was aired on the Kronika news programme on TVP3 (Material in Polish).
https://krakow.tvp.pl/88031226/sukces-krakowskich-naukowcow-opracowali-terapie-leczenia-osteoartrozy
Prof. Ewa Zuba-Surma and Dr. Anna Łabędź-Masłowska, the inventors of MesoCellA-Ortho, were interviewed in the laboratory of the Department of Cell Biology at the Faculty of Biochemistry, Biophysics and Biotechnology at Jagiellonian University. During the interview, they discussed their invention and its potential to regenerate tissue structures damaged by osteoarthritis.
2. An article by Katarzyna Prus entitled “Joint degeneration robs millions of Poles of their mobility. A new drug is being developed” published on the WP abcZdrowie portal (Article in Polish):
This article is an interview with Prof. Ewa Zuba-Surma about her team's development of an innovative medicinal product named MesoCellA-Ortho for the treatment of osteoarthritis. The inventor presents the nature of the product, its biological potential and the results of clinical trials, as well as the planned stages of commercialising the product.
3. An article by Karolina Majchrzak entitled “A breakthrough in joint treatment. Polish scientists have developed a therapy” which was published on the Interia GREENWEEK portal (Article in Polish):
https://geekweek.interia.pl/medycyna/news-przelom-w-leczeniu-stawow-polscy-naukowcy-opracowali-terapie,nId,22167615
This article provides an overview of the development of the MesoCellA-Ortho drug and its potential applications in the treatment of osteoarthritis. It includes excerpts from an interview with Prof. Ewa Zuba-Surma and Dr. Anna Łabędź-Masłowska, the inventors of the product.
4. An innovative technology for obtaining autologous mesenchymal stem cells AT-MSCs from a patient’s adipose tissue, developed by our Team, led by Prof. Ewa Zuba-Surma, with the significant contribution of Dr Anna Łabędź-Masłowska, won first place in the “Eureka! DGP - Discovering Polish Inventions” competition.
The competition aims to promote the achievements of Polish science by recognising inventions developed at Polish scientific institutions and submitted to the Patent Office of the Republic of Poland. The award was accepted on behalf of the winning team by Dr Anna Łabędź-Masłowska, co-inventor of the invention, and Dr Klaudia Polakowska, innovation broker at the CITTRU Technology Transfer Centre of the Jagiellonian University.
The awarded invention concerns a new, optimised method for obtaining human mesenchymal stem cells from a patient’s adipose tissue, AT-MSCs, for use in regenerative medicine. These cells have exceptional pro-regenerative properties, enabling them to support tissue repair, reduce inflammation, and stimulate healing processes in various tissues.
The developed method, known as the “MesoCellA-4U Platform”, makes it possible to obtain AT-MSCs that can subsequently be used as the active substance of biological advanced therapy medicinal products, ATMPs. This platform has already been used in the manufacture of the medicinal product “MesoCellA-Ortho”, intended for the treatment of osteoarthritis. The product was administered to patients as part of the BioMiStem-CT clinical trial, NCT05081921, conducted by the Jagiellonian University in collaboration with the Galen-Ortopedia clinic in Bieruń under the supervision of Prof. Krzysztof Ficek. The study confirmed the medicinal product’s high safety profile as well as its efficacy, including the effect of the cells on reducing knee joint pain, increasing patients’ physical activity, and improving their quality of life.
By standardising the process of obtaining AT-MSCs, it is possible to develop advanced and modern ATMPs with reproducible functional properties and high pro-regenerative potential. The MesoCellA-4U Platform provides a basis for the development of further ATMPs based on AT-MSCs and their secretome-derived products, including extracellular vesicles, supporting the regeneration of damaged tissues. These include solutions being developed for degenerative and inflammatory diseases, as well as for the treatment of tissue defects not only in orthopaedics, but also in other areas of medicine, such as cardiology, neurology, and traumatology.
The awarded technology was developed as part of the BioMiStem project, “Development of optimised methods for treating tissue damage based on innovative composites and mesenchymal stem cells and their derivatives in patients with civilisation diseases”, co-financed by the National Centre for Research and Development.
The recognition of a technology developed at the Jagiellonian University confirms that innovations created at the University have real potential to set new directions in regenerative medicine. The solutions under development may contribute to the creation of further, more effective and safer methods for treating damaged tissues, and represent an important step in the advancement of modern therapies. This achievement also highlights the importance of a comprehensive approach to innovation development - from basic research and intellectual property protection, through technology development, to activities aimed at implementation and commercialisation. It is the collaboration between science, technology, medicine, and business that creates solutions with genuine implementation potential, which may in the future contribute to the development of modern therapies and improve the quality of patient care.
