Stem cell banking: current issues
On September 21, the international symposium "Topical issues of donor and personal storage of stem cells" was held in Moscow at the Olympic Hotel, which was attended by leading experts in the field of cell technologies and stem cell banking from Russia, CIS countries and Europe.
Organizers of the symposium: JSC Institute of Human Stem Cells, BSC "Gemabank", Journal "Cell Transplantology and Tissue Engineering" and Interregional Public Organization of Specialists in Cellular Technologies and Regenerative Medicine.
The participants and guests of the symposium were welcomed by Igor Volotovsky, Executive Secretary of the Belarusian Academy of Sciences, and Artur Isaev, Director General of the Human Stem Cell Institute. Artur Isaev noted that the symposium was organized to exchange information between scientists from Russia and other countries, discuss practical issues of work in the field of cellular technologies, and is also aimed at integrating cord blood banks with the European network of NetCord banks.
The report of Dr. Torsten Tonn, Institute of Transfusiology and Immunohematology (Frankfurt), Germany, was of great interest to the participants of the symposium and was devoted to the successful results of a unique TORCARE-AMI study on the use of freshly isolated bone marrow stem cells for the treatment of myocardial infarction. Multicenter studies were conducted on 200 patients across Europe, mainly in Germany. The cells were injected into patients intracoronarily (stem cells were transplanted directly into the vessels of the heart). After the injections, the expulsion fractions improved by an average of 5-7%. According to the results of 2-year follow-up, positive statistics on survival and quality of life of recipients were noted.
Director of Science of the Institute of Human Stem Cells, Head of the Laboratory of Cellular Technologies, Sergey Kiselyov, in his report told about the world-class discovery: for the first time in the world iPS cells were obtained from the endothelium of the umbilical vein – cells with induced pluripotency. A stem cell similar in properties to embryonic stem cells (ESCs) is obtained from a non-stem cell. It is important that such cells can be obtained from any person and applied to him his own 100% compatible derivatives of these cells (for example, differentiated into cardiomyocytes or beta cells of the pancreas) and treat cardiovascular diseases, diabetes, etc.
The unique discovery of Professor Kiselyov S.L. provides ample opportunities for expanding the field of activity of private storage banks, since iPS cells have great prospects for use. Umbilical vein endothelial cells are young and do not have the "burden of years lived", they are rich material for further scientific research and clinical application.
Two presentations were devoted to the specifics of the work of cord blood donor banks (PCs) of the NetCord network. The first report was devoted to the ideology of quality standards of donor PC banks, which should provide transplant centers with ideal quality samples of hematopoietic cord blood stem cells (HSCS). To achieve this goal, a unified information technology platform of NetCord banks and the National Registry of Bone Marrow Donors of the USA (NMDP) was created, providing efficient and fast selection of donors. This was described in detail in the second report by Holger Gressman, an information technology expert at Heinrich Heine University, Germany, Dusseldorf.
Sergey Maksimov, Head of the Licensing and Legal Support Department of Roszdravnadzor, in his speech spoke about the work of the department carried out in this area to monitor licensing activities, issue licenses and register new technologies and noted that there are a number of objective obstacles to the widespread introduction of new cellular technologies in the Russian Federation:
• Roszdravnadzor does not have the authority to punish legal entities without licenses that work in violation of licensing legislation. The usual mechanisms – through the court – are ineffective, because the courts can not cope, and such cases are canceled due to the expiration of the statute of limitations for their consideration (2 months).
• The lack of a sufficient legal framework, the creation of which in cellular technologies is a matter for many years. Perhaps in 2 years there will be a bill in the State Duma. It is necessary to create working and initiative groups of specialists and lawyers to create these documents. Roszdravnadzor is ready to provide a platform for such work, supervise it and contribute to this work.
• Analogs of the legislations of other countries are unacceptable for the Russian Federation, because legal systems are too different from each other to simply adopt this experience, in addition, the legal field in this area is also being formed in other countries.
The report of the representative of the personal PC storage bank "Gemafond" (Kiev, Ukraine) showed that in Ukraine there are exactly the same problems in the implementation of personal PC storage services as in Russia: insufficient legal framework, low awareness of doctors and the population about the prospects of this service. The speaker also spoke about the situation in Poland, where the first PC donor bank was established in 1996, and now there are 8 personal storage banks and 2 donor banks in Poland, which indicates the demand for this service in Eastern European countries.
The report of the representative of CJSC "Cryonics", St. Petersburg, Surkov K.G. was devoted to the drug "Cryocell" developed by CJSC "Cryonics". Ideologically, it is possible, based on the regulatory documents of the European Medical Agency (EMEA), to consider drugs containing living human cells as a drug. Therefore, the drug "Cryocell", containing allogeneic cord blood cells, can be used to stimulate regenerative processes in various tissues, correction of immunological pathology. The basis for these works were numerous experimental studies successfully conducted in many research centers. After successful preclinical trials, Cryocell is supposed to be used for the treatment of many non-hematological diseases, including myocardial infarction and heart failure.
The participants of the symposium expressed their gratitude to the organizers for a well-conducted event. There was an opportunity to listen to reports in English with translation into Russian and vice versa, so that nothing hindered the communication of specialists, including during a break and a buffet.
In the latest issue of the journal "Cell Transplantology and Tissue Engineering" the abstracts of the symposium participants' speeches were published.
Portal "Eternal youth" http://vechnayamolodost.ru according to the materials of the Gemabank press service
06.10.2009