Source Photo: acrusbiomed.ru
Both products work similarly: donor skin cells are grown in a laboratory and placed on a special substrate that mimics real skin structure. BSE contains two cell types: mesenchymal stem cells and keratinocytes (the main cells of the skin's upper layer). DE consists of stem cells and a biocompatible coating. The key advantage is that a small amount of donor material can produce coverage for large skin areas. This is especially important for extensive burns, when the patient doesn't have enough of their own skin for transplantation.
Researchers will test BSE on 104 patients with second- and third-degree burns. The product accelerates healing and helps prevent formation of severe scars. They will test DE on 96 patients with trophic leg ulcers. Doctors can apply it on an outpatient basis, without surgery or anesthesia, unlike transplanting the patient's own skin.
The studies are taking place at Privolzhsky Research Medical University in Nizhny Novgorod, F.I. Inozemtsev City Clinical Hospital in Moscow, and medical centers in St. Petersburg and Moscow.
Akrus Biomed initiated the clinical trials. Scientists from the N.K. Koltsov Institute of Developmental Biology of the Russian Academy of Sciences developed the technology. After testing, the product can receive registration from Roszdravnadzor. Last year, Akrus Biomed invested 460 million rubles in creating living skin production facilities. After registration, the company plans to produce up to 70,000 units per year, primarily for hospitals in the Moscow region.
Meanwhile, Russia is conducting trials of an even more advanced product, a combined skin equivalent (Combi-BSE) that contains the patient's own cells. If everything succeeds, Russia will have a full-fledged skin transplant bank. In the future, these technologies could be used not only for treating burns, but also in plastic surgery, oncology, dentistry, and other areas of medicine.