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. Last Updated: 07/27/2016

Blue Blood Waiting for Royal Treatment




PUSHCHINO, Moscow Region -- Three years after federal health authorities licensed a revolutionary blood substitute, the medicine intended to save lives is still not widely used due to its high price and relative obscurity in the international medical community.


The artificial blood, known as perftoran, has received approval from a number of Russian medical experts and has been hailed by local scientists and doctors as a substance that can be used in transfusions with all the benefits of donor's blood but without the risks and limitations f such as blood type incompatibility or infection with HIV, hepatitis or other dangerous viruses.


"Perftoran can be administered to thousands of accident patients with blood loss of 2 liters and more," said Professor Valery Khvatov, head of the immunology laboratory at Moscow's Sklifosovsky Institute, which admits up to 4,000 patients a year with critical blood loss of 4 liters or more. Khvatov was a member of the group of top medical experts who performed clinical tests on perftoran.


A number of blood substitutes are now used in international medical practice f such as Ringer-Lactate solution, which contains electrolytes and glucose in a concentration similar to that in blood plasma f but they can only replenish lost blood in terms of volume, without providing its oxygen-carrying capacity.


Perftoran f also called blue blood because of the milky emulsion's bluish shade f is hailed as revolutionary by its creators and some doctors because they say it not only replenishes blood volume but fulfills the blood's crucial function of carrying oxygen.


"Perftoran is a fully functional blood substitute; it dissolves oxygen and transports gases well, which is important in cases of severe blood loss when the amount of erythrocytes [red blood cells responsible for transporting oxygen] is dangerously low," said Professor Genrikh Ivanitsky, head of the laboratory at the Russian Academy of Sciences Institute of Theoretical and Experimental Biophysics in Pushchino, about 110 kilometers south of Moscow, where perftoran was created.


Professor Thomas Ming Swi Chang, director of the Artificial Cells and Organs Research Center at McGill University in Montreal, said the importance of blood substitute research, considered avant-garde some 20 years ago, is no longer disputable.


Chang said he has heard of the blood substitute developed in Russia but was unfamiliar with the details and was hesitant to give an assessment.


"We hold symposiums and invite all the scientists involved in the research worldwide, but they [the Russian scientists] never come here, so we know little about the research in Russia," Chang said in a telephone interview from Montreal.


"It has been more than 10 years of intensive efforts and we still have nothing ready for routine use, but some research is at the final stages of clinical testing. Some results looks very good, others not so good," Chang said.


Oxygen-carrying blood substitutes derived from perfluorocarbon organic compounds, the same group of compounds used in perftoran, have been developed but are still being researched in the United States and Japan. Both oxygent, developed by the U.S.-based Alliance Corp., and the Japanese-developed fluosol are "presently at clinical research trials aimed at demonstrating their efficiency and tolerance," said Dr. Luc Noel, coordinator of Blood Transfusion Safety at the World Health Organization, in a telephone interview from Washington.


Perftoran was developed by a group of scientists led by the late Professor Felix Beloyartsev, who had been working on the project from 1979 to 1985.


Just as the clinical trials were nearing the final stage in Pushchino, Beloyartsev's research was denounced by a number of medical experts and media reports as pseudoscience.


The scientist was accused of conducting dangerous tests on humans and extorting money from his subordinates. Ivanitsky said that in reality Beloyartsev and his employees, constantly short of state financing, were investing their own savings in constructing and buying the equipment necessary for their work.


Beloyartsev was also accused of improper use of ethyl alcohol, which resulted in an abortive criminal investigation against him. In 1985, he committed suicide at the age of 44.


After his death, funding for the perftoran project stopped altogether and so did official research, but the scientists continued their work underground. Officially, it resumed only in 1990, when Ivanitsky became the head of the project and had to start the process of testing and licensing the emulsion all over again.


In 1997, perftoran was finally registered and approved for production and sale by the Health Ministry and the State Pharmaceuticals Committee. Last year, Ivanitsky was among a group of scientists and medical experts to receive a state prize for perftoran; Beloyartsev was awarded posthumously.


Invented almost two decades ago, perftoran could have been used to save soldiers' lives during the military campaigns in Afghanistan and Chechnya, Ivanitsky said, adding that the researchers' biggest concern is that even now perftoran remains too expensive to be widely used for its initial purpose f emergency medicine.


Recent tests showed that in addition to being an oxygen carrier, perftoran also improves microcirculation and dissolves cholesterol clots in blood vessels, helps treat hepatitis and can be used as a substance in which organs intended for transplant surgery can be preserved for a long period of time, Ivanitsky said.


Produced in small quantities and priced at $200 for 400 milliliters, the emulsion is used by a number of medical institutions, including the Eye Microsurgery Clinic, Bakulev Institute of Cardiovascular Surgery and Burdenko Military Hospital. Usually it is used for blood transfusions during routine surgery, Ivanitsky said.


"It would be ideal to have it [perftoran] at the emergency unit and use it when it's necessary to treat several accident patients with severe blood loss simultaneously, but the high cost makes that imposible now," Khvatov of the Sklifosovsky Institute said.


Ivanitsky said that until the institute starts receiving large orders for perftoran, the high production costs will make it impossible to lower the price.


He said no foreign or local pharmaceutical companies have expressed any serious interest in launching mass production of perftoran, adding that offering it to Western countries would mean starting the long process of research and testing all over again as licenses from Russian health and pharmaceutical authorities are not recognized in the West. So Ivanitsky sets his hopes on the local market in Russia and the Commonwealth of Independent States, where prominent doctors are familiar with perftoran.


Although Perftoran remains virtually unknown to the international medical community, experts said the appearance of an oxygen-carrier is important.


Dr. Noel of the WHO said the appearance of any oxygen-carrying product gives a chance to "avoid blood transfusion or at least postpone it until it's determined that it meets safety standards."


"We are certanly interested in these developments, provided they can answer to emergency needs. The availability of these compounds will certainly be progress," Noel said, adding that he has been aware of perftoran's existence for a long time but does not know any of the details.