Russia's first stem cell-based medical product approved for trials

Russia's first stem cell-based medical product approved for trials

On March 12, the Russian Ministry of Health granted approval for clinical trials to test the efficacy of the country's first stem cell-based product for knee cartilage replacement.

Generium Pharmaceutical has developed the autologous biomedical cellular product (BMCP) (cartilage implant) for the restoration of cartilage in the knee joint. According to ACTO, this is the first BMCP in Russia submitted for state registration in accordance with Federal Law №180-ФЗ passed in 2016. All approvals for clinical trials of BMCP are entered in a separate registry. Last year, Generium was also the first company to receive a license for the production of BMCPs. 

Loss of cartilage which acts as a layer of shock-absorbing tissue in the joints is a common cause of knee pain and arthritis which affects many thousands of Russian. Unfortunately, once damaged, cartilage can not be fixed therefore novel products using stem cell technology like this one created by Generium have the potential to revolutionize treatment. 

“In vitro-grown cartilage can replace the lost tissue in the joint and relieve the patient from traumatic endoprosthetics. About 2000 - 3000 patients a year come to the Ilizarov Center with this problem. This new technology will primarily help patients with osteoarthritis of the knee,” said Evgeny Ovchinnikov, Deputy Director for Scientific Work at the National Ilizarov Medical Research Center for Traumatology and Orthopedics.

It seems likely that this approval will mark the beginning of a significant increase in BMCP submissions. Russian scientists have a large list of stem cell regenerative products already in development including an analogue of human skin, corneal tissues and liver cells.

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