
First biomedical cell product is approved in Russian Federation
The press service of the Russian Ministry of Health announced the registration of the first BMCP - the Izitens product of the Generium company.
Izitens is an autologous (the patient's cells are intended to be administered to the same patient) BMCP intended for the treatment of damage to the cartilage of the knee joint in patients over 18 years of age.
The mechanism of action of the Izitens product is that the product, which includes human cartilage cells, is injected into the site of cartilage tissue damage, where the cells migrate to the surface of the defect and fill it with hyaline matrix components, which has a regenerative effect. This technology is intended for the treatment of grade III or IV cartilage damage to the knee joint with a defect size ranging from 1 to 10 cm2.
According to the Deputy General Director of the Generium company, corresponding member of the Russian Academy of Sciences Dmitry Kudlay: “The method developed by Generium scientists involves the removal of a section of healthy cartilage tissue through arthroscopy. The resulting cells are scaled and formed into chondrospheres, then they are injected into the patient. The spheres grow on the surface of the defect and gradually form new healthy tissue. The method is minimally invasive, after a short rehabilitation the patient can lead a normal life.”
The Generium company received a certificate of registration of the ISITENS trademark in 2020, and in 2021 - permission for clinical trials (CT) of the product. It is worth noting that the clinical trial is planned to be completed only at the end of 2024. According to the entry in the RCT registry, Izitens BMCP are spheroids of autologous human chondrocytes bound by a matrix. The clinical trial involved 8 clinical centers in Moscow, Smolensk, Kurgan and Samara.
References:
- https://mgzt.ru/node/19093
- https://zdrav.expert/index.php/%D0%9A%D0%BE%D0%BC%D0%BF%D0%B0%D0%BD%D0%B8%D1%8F:%D0%93%D0%B5%D0%BD%D0%B5%D1%80%D0%B8%D1%83%D0%BC_(Generium)
- https://pharmvestnik.ru/content/news/Minzdrav-zaregistriroval-pervyi-biomedicinskii-kletochnyi-produkt.html
- https://grls.rosminzdrav.ru/Ree_orgCI2.aspx?moduleId=1