In July, Acrus Biomed, a specialized biotechnology company focused on the development and production of high-tech medicines, received approval to conduct Phase 1 and 2 clinical trials of two dermatotropic products: biological skin equivalents (BSE) and dermal skin equivalents (DSE), also known as living skin equivalents. During the research, the safety and efficacy of BSE will be evaluated in patients with thermal burns, while DSE will be studied in patients with trophic venous leg ulcers, in accordance with data from the State Register of Medicines (GRLS).
Both products are constructed using cultured allogeneic human skin cells and a carrier material that mimics the natural skin’s structure. The developments are intended for the treatment of burns, trophic ulcers, long-term non-healing wounds, as well as for other areas of dermatological and cosmetic care.
According to the state register, 104 patients will participate in the BSE trials, and 96 patients will take part in the DSE trials. The research is scheduled to be completed in October 2025.
BSE incorporates mesenchymal stem cells, keratinocytes, and a wound coating that resembles the extracellular matrix of skin. According to the developers, the LSEs accelerate the restoration of the skin and reduce the risk of scarring. Experts believe that LSEs may be the best choice for treating the effects of mine-blast injuries and extensive burns.
DSE also contains allogeneic mesenchymal stem cells and wound coating, but is intended for the treatment of chronic wounds. It can be used on an outpatient basis or in a day hospital settings. Unlike traditional autodermoplasty, DSE has no contraindications and is more affordable.
As Moscow Mayor Sergei Sobyanin said earlier, Acrus Biomed is preparing to release its first products based on the researcch of the Koltsov Institute of Developmental Biology of Russian Academy of Sciences. The products are a biological skin equivalent and a dermal skin equivalent, which are used to treat burns and long-term non-healing wounds.
The company plans to initially supply its products to medical institutions in the Moscow region, thereby reducing dependence on imported biotechnologies. Investments in the production of BSE and DSE amounted to 460 million rubles. It is planned that the annual production of biomedical cellular products based on these technologies will reach 70,000 units.
