Researchers at Jagiellonian University have developed a breakthrough osteoarthritis (OA) therapy called MesoCellA-Ortho, which has successfully passed Phase II clinical trials. This innovative treatment uses mesenchymal stem cells (MSCs) derived from the patient’s own fat tissue to reduce pain and stimulate regeneration of damaged joints.
The method is the result of over 10 years of research led by Prof. Ewa Zuba-Surma from the Department of Cell Biology, in collaboration with Galen-Ortopedia, where clinical trials were conducted.
The procedure includes the process of making a preparation consisting of mesenchymal stem cells (MSCs) isolated from the affected patient’s fat tissue and then cultivated and multiplied under strictly controlled conditions. The developed technology also comprises readying the patient for taking the medication, the use of a specific formulation of MSCs as well as the process of administering the medicinal product to the diseased joint.
The developed method, which has been named MesoCellA-Ortho, aims to treat osteoarthritis of joints, including knee joints. It is still necessary to conduct the third phase of clinical trials before the medication can enter the market. For that purpose, the JU would like to invite a partner institution from the MedTech sector.
Mesenchymal stem cells are present in the body in multiple tissues, especially in tissue and bone marrow. These cells possess unique properties – under the impact of various factors they transform (differentiate) into cells of various tissues, including bone, cartilage, or fat. They also have a significant secretory potential, because of which they play an important and beneficial role in regulating many processes related to tissue regeneration, including the emergence of blood vessels as well as reducing and quelling inflammations.
MesoCellA-Ortho can be classified as an innovative personalised treatment which relies on natural biological mechanisms based on patient’s own stem cells. Essentially, it is an autological cell transplant, which potentially improves the effectiveness of treatment and reduces the risk of side effects or complications related to the possible transplant rejection.
Both completed phases of clinical trials were carried out in collaboration with Galen-Ortopedia. They involved nearly 200 patients affected with osteoarthritis, whose damaged knee joints were treated with the new drug.
Preclinical tests on large animals confirmed the therapy’s regenerative effects, with joints showing full recovery within six months.
The next, third stage of clinical trials will require the singing of a partnering agreement with a subject with a sufficient potential and experience. After the trials are successfully concluded, the Jagiellonian University aims to put the medication to commercial use, which requires obtaining permission from a number of institutions, including the European Medicines Agency. The treatment is already protected by a patent.
Designers of the new osteoarthritis treatment method (from the left): Prof. Ewa Zuba-Surma, Dr Anna Łabędź-Masłowska, and Prof. Krzysztof Ficek. Source: Jagiellonian University
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