GENERIUM – the first in Russia to receive a registration certificate for a biomedical cell product
The first advanced therapy medicinal product (ATMP) in Russia was registered by GENERIUM under the trade name EASYTENSE. It is an autologous product based on chondrocytes, the main cells of cartilage tissue, and is intended for the restoration of damage to the cartilage of the knee joint with a defect area of up to 10 square cm.
Chondrocytes isolated from a biopsy of a patient’s healthy cartilage are cultured in vitro at the licensed production facility of GENERIUM. The product is a three-dimensional structure made from the patient's own chondrocytes - spheroids, implanted into the site of a cartilage tissue defect. Chondrocytes fill the defect area with components of the hyaline matrix, providing a regenerative effect.
The cellular product is produced individually for each patient and is intended exclusively for personalized use, which eliminates the risks of rejection and infection with foreign pathogens. The entire process from collecting biomaterial to transplanting cultured cells into the defect site takes an average of 4–8 weeks.
“The use of ATMPs in medical practice is associated with a change in the treatment paradigm itself. Personalized technologies in medicine will improve the quality and life expectancy of a person, and also open up prospects for curing previously incurable diseases,” said Dmitry Kudlay, Vice President of JSC GENERIUM, Corresponding Member of the Russian Academy of Sciences.
EASYTENSE is the only fully licensed analogue of the European ATMP in demand for the restoration of damage to the cartilage of the knee joint Spherox/Chondrosphere.
The first manipulations to restore cartilage tissue of the knee joint using ATMPs will begin to be carried out at the bases of the Federal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after Sechenov of the Ministry of Health of Russia (Moscow) and the Federal State Budgetary Institution – Federal Centre for Traumatology, Orthopedics and Endoprosthetics of the Ministry of Health of Russia (Smolensk). Specialists from these medical institutions gained experience working with ATMPs as part of Phase III clinical trials.