The SB-REG-CSKIN/FSKIN line is an innovative veterinary candidate for a biological medicine developed by Sanford Biotech based on many years of research into the use of stem cells (MSCs) for use in dogs and cats in the treatment of autoimmune diseases, particularly atopic dermatitis (AD).
In SB-REG-FSKIN/CSKIN, the active substance is a suspension of live, allogenic mesenchymal stem cells (MSCs) derived from adipose tissue, prepared in the form of a sterile suspension for intravenous administration in the form of a drip. The preparation will be available in a deep-frozen form, ready for use immediately after thawing, in an ‘off the shelf’ formula.
SB-REG-FSKIN/CSKIN is dedicated to dogs and cats with atopic dermatitis (AD). Atopic dermatitis is a chronic, recurrent skin disease with complex aetiology, in which genetic factors, skin microbiome disorders, hypersensitivity to environmental allergens and abnormal immune response play an important role. Clinical symptoms include redness, itching, skin damage, exudates, secondary infections, and pain of varying severity. It is estimated that up to 15% of the canine population suffers from AD.
The therapeutic effect of SB-REG-FSKIN/CSKIN is based on the immunomodulatory properties of MSCs, which interact directly with immune system cells through intercellular signalling. These cells restore immune tolerance by inhibiting chronic inflammation and limiting the excessive immune response that underlies AD. As a result, the therapy not only alleviates symptoms, but also acts causally by influencing the mechanisms of the disease.
Standard treatment for AD in dogs and cats involves the use of glucocorticosteroids, cyclosporine, oclacitinib or antihistamines. These therapies alleviate symptoms but do not address the causes of the disease and may cause side effects with long-term use.
SB-REG-CSKIN acts on the cause, supporting the skin's natural regenerative processes and restoring its physiological immune balance.
SB-REG-CSKIN/FSKIN represents a segment of dermatological cell therapies with high market potential. The market for the treatment of skin diseases in pets is estimated at over USD 2.8 billion annually, with an annual growth rate of approximately 7%.
The product is in line with the trend towards premium veterinary biotherapies and may be the first MSC therapy in veterinary dermatology registered in the EU, targeting the market of approximately 13.5 million dogs living in Europe with atopic dermatitis.
The safety and efficacy of MSCs in veterinary dermatology have been confirmed in numerous in vivo and in vitro studies.
Studies conducted by Sanford Biotech and academic institutions (including the Polish Academy of Sciences, University of Life Sciences in Lublin, and University of Warmia and Mazury) have demonstrated:
a reduction in AD symptoms after a single administration of MSC,
no rejection reactions or adverse effects,
improved skin quality and reduced itching within 14–30 days.