07 May 2009

Cellular technologies: hurdling

On December 24, 2008, the Russian Academy of Medical Sciences hosted a meeting of the Presidium of the Russian Academy of Medical Sciences dedicated to the possibilities of using cord blood stem cells in the treatment of a number of diseases of the nervous system.

A group of scientists led by Academician V.N.Smirnov reported to the members of the presidium and numerous listeners the results of clinical studies of methods of cord blood stem cell therapy for diseases such as Alzheimer's disease, Parkinson's disease, schizophrenia, cerebral palsy, brain injuries. During the discussion of the results obtained and the prospects of this therapy, it seemed that the scientific testing platform was insufficiently developed. Most of the scientists present agreed that it is too early to talk about the success of the new treatment method. In 2009, V.N. Smirnov's group plans to continue clinical research in this area.

The editorial board of the journal "Cell Transplantology and Tissue Engineering" decided to ask the leading specialists of Russia what are the reasons for the slow entry into clinical practice of technologies using cord blood stem cells.

V.A. Kozlov, Academician, Director of the State Research Institute of Clinical Immunology:
"The use of cord blood stem cells in medicine, as well as adult stem cells, should be considered from the standpoint of biosafety of the state. Accordingly, the creation and operation of Cord Blood Banks should also be supported by government agencies in order to create a national, strategic reserve of stem cells. There is no understanding of this problem in the structures of the legislative and executive authorities of the Russian Federation, and this is the main reason for Russia's significant lag in the field of practical application of stem cells."

A.A. Isaev, General Director of JSC "Institute of Human Stem Cells":
"Official clinical studies related to the possibility of using cord blood stem cells, as well as full-fledged clinical studies in other areas are not conducted in Russia at all. Among the main reasons is the opposition in the registration of cellular and clinical technologies of the former Expert Council of the Ministry of Health and Social Development, which is currently disbanded after several organizations appealed to the Arbitration Court with a request to recognize the decisions of Roszdravnadzor on refusal to register new technologies illegal. We can say that today this obstacle is no longer there. The next reason is the indecision of Roszdravnadzor officials and the lack of clear regulation of the procedure for conducting official clinical trials of new cellular technologies. Also, Russian researchers and applicants lack confidence in their abilities. We need to work more actively with Roszdravnadzor, try to find solutions with them. And there is an Arbitration Court to resolve stalemates. Another reason is that so far there are few significant and noticeable clinical results in practice among our foreign colleagues: both in the USA and in Europe, which does not give confidence to Russian researchers."

D.G. Polyntsev, CEO of Trans-Technologies LLC:
"There is no algorithm for introducing new technologies in our healthcare system. With the current abundance of rhetoric about high technologies in Russia, we remain a very conservative country, whose entire system is extremely wary of any innovations."

B.V. Afanasyev, Director of the R.M. Gorbacheva Institute of Pediatric Hematology and Transplantology:
"Despite the fact that Russia has developed a service for the preservation of cord blood cells, it is targeted and does not provide for the use of samples for scientific or clinical purposes. However, the first steps towards the creation of the first public banks of anonymous cord blood samples have already been taken. Such banks operate in Moscow, Samara, St. Petersburg. These centers are actively working with transplant clinics, responding to their requests, providing information about the possibility of using stored samples. The composition of umbilical cord blood cells and their potential are being investigated. Maybe not so fast and active. It should be remembered that cord blood banks in the USA and Europe began to be created in the 80s of the last century, and in Russia - in 2002."

The full version of the interview with leading experts in the field of cellular technologies can be read in the latest issue of the journal "Cell Transplantation and Tissue Engineering" or on the official website of the journal.

Portal "Eternal youth" www.vechnayamolodost.ru according to the materials of the Gemabank press center

07.05.2009

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