Isitens

2023: Product Registration

In mid-December 2023, the Ministry of Health of the Russian Federation announced the registration of the first biomedical cell product. We are talking about a drug called Isitens, which was developed by Generium.

According to the press service of the Ministry of Health, Isitens is "the first industrial experience in the use of autologous cell product transplantation technology." It is intended to treat knee cartilage in patients over the age of 18. The medicine contains human cartilage cells.

Ministry of Health announced the registration of the first biomedical cell product

The drug is injected at the site of cartilage tissue damage, where they (cartilage cells) migrate to the surface of the defect and fill it with hyaline matrix components, which has a regenerative effect. The technology is designed to treat grade III or IV cartilage injuries of the knee joint with a defect size of 1 to 10 cm2 in patients by transplanting the patient's own chondrocytes.

At the end of November 2023, Dmitry Kudlai, Deputy General Director of Generium JSC, during the third Congress of Young Scientists, said that the first Isitens technology in Russia for the treatment of osteoarthritis is being prepared for widespread implementation after a successful final stage of testing. As Kudlai explained, the process is carried out without extensive joint surgery and requires only arthroscopy to pick up healthy tissue measuring only 3-4 grams. This fabric is then used to grow new.

According to the deputy head of Generium, by the end of 2023, Isitens is the only cellular product licensed for industrial production. The treatment procedure takes only 72 hours, after which the rehabilitation period begins, and the patient returns to normal life. Cultured human cells are widely used in regenerative medicine.^[1]

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