The SPRS therapy: 5 years on the esthetic medicine market
The market of regenerative medicine is moving forward by commercially successful technologies. Owing to such technologies, the regulatory authorities acquire experience working in the field of regenerative medicine and evaluation of novel cellular technologies.
Market for cellular technologies
At present, there are many problems associated with transition from experimental work to clinical trials and then to successful marketing.
One of these problems is enlarging the production scale to enter the potential market. Another problem is logistics, especially when production is connected with personified products of cellular technology. Logistics plays a strategically significant role in the biotechnological sector. The Human Stem Cells Institute (HSCI) is the leading biotechnological company which can serve as an example how to develop, produce, and promote the innovative products of cell technologies including the SPRS therapy.
We consider our company as a leader in the field of regenerative medicine possessing a unique experience in development and manufacturing of cell technologies products and their entering the market.
The SPRS® therapy: the personified medical technology
The SPRS therapy is a personified medical technology, which means that the cell product is manufactured for each patient individually. We successfully work in cooperation with clinics from different regions of Russia and also accept patients from abroad.
To successfully perform the procedure, it is necessary to keep the strict terms of manufacturing and delivering the cell product to clinics. For this purpose, we have developed technological processes [standard operating procedures (SOP)] which determine all logistic steps: taking a bioptate by physician, delivering the bioptate to our laboratory-manufacturing complex, creation of the personified cell bank, estimation of the skin regeneration potential (Skin Passport®), and conducting the SPRS therapy course by physicians in clinics.
The SPRS therapy is mainly performed in Moscow clinics of esthetic medicine (above 30 clinics). However, in 2012 we started cooperation with clinics in 13 towns of Russia. The total number of patients whom the service has been provided since the moment of entering the market reached 550 people at the end of 2014. About 50% patients asked to repeat the procedure in the other skin regions.
Despite the financial crisis in Russia, the income from the SPRS therapy service including long-term storage of patient's own skin fibroblasts was increased by 16.4% in 2014 as compared to 2013.
International acknowledgement of our technology
The Russian cell technology received acknowledgement from the world scientific community. For the first time, the results of Russian clinical trials on the cell technology, the SPRS therapy, were published abroad in scientific journal: "Clinical-instrumental and Morphological Evaluation of the Effect of Autologous Dermal Fibroblasts Administration" (Zorin V., Zorina A., Cherkasov V., Deev R., Kopnin P., and Isaev A.)
http://onlinelibrary.wiley.com/doi/10.1002/term.1976/abstract.
For the first time, in the field of Russian cell technologies, the US Patent Agency granted the patent US 8,790,890 В2 («Diagnostic method for connective tissue and its application». V.L. Zorin, A.I. Zorina, V.R. Cherkasov, P.B. Kopnin). Another patent ("Method for estimation of the skin regenerative potential") provides the possibility to obtain legal protection for the SPRS technology and its unique diagnostic procedure in the USA.
For the first time, in Russia, an international patent application has been submitted according to the PCT protocol [Zorin V., Zorina A., Cherkasov V., Kopnin P. Diagnostic method for connective tissue and its application. WO 2013/051963 (filed 11/04/13; priority date: 03/10/11)]. This step was required to obtain global patent protection of the SPRS therapy, in particular, the personified skin diagnostics (Skin Passport®). This provides legal protections in the countries which permit submitting patent applications in English. In 2013 and 2014, this international patent application was reviewed at the national/regional level (in countries covered by the Eurasian Patent Agency and the European Patent Agency, the USA, and Brazil).
http://hsci.ru/news/press-relizy/finansovye_i_operatsionnye_rezultaty_oao_iskch_za_2014_god_po_rsbu
The SPRS® therapy is the only technology approved in Russia which allows one to correct the age-related skin changes and which is based on the use of patient's own skin fibroblasts. The Human Stem Cells Institute (a public biotechnological company) is the only company which has the official authorization to apply this technology in Russia.
- The SPRS therapy. Test on ourselves. Part 1
- Cell technologies and skin types
- Biological insurance for the skin: the SPRS bank