The FDA has allowed stem cell testing: details
The process has startedMikhail Alekseev, MedNovosti
The decision of the American supervisory authority successfully coincided with the inauguration of Barack Obama. The scientific community is waiting for the first black president of the United States to repeal the anti-scientific laws adopted by the George W. Bush administration in favor of the religious lobby.
The Geron Inc study, approved on Friday by the U.S. Food and Drug Administration (FDA), represents the first stage of clinical trials aimed at evaluating the safety of the experimental technique. It is planned to involve only ten patients with paralysis of the lower extremities, which developed as a result of spinal cord injuries. It is expected that no later than two weeks after the injury, each subject will receive a single injection of a drug based on human embryonic stem cells.
The evaluation of the results of the experiment will be completed in 2010. Based on them, Geron plans to obtain permission for an expanded version of the study involving more patients and with more significant dosages of stem cells.
There are two types of stem cells: embryonic and "adult". The first ones are found only in embryos in the early stages of development and are completely universal cells capable of turning into cells of any type of tissue. The latter serve to restore damaged tissues and maintain the normal life cycle of constantly regenerating organs. They are also present in the body of an adult. In the vast majority of ongoing research, it is "adult" stem cells that are used.
For the first time, the FDA grants permission for clinical trials of human embryonic stem cells. The approval process was long: Geron announced its intention to conduct this study back in 2006. The FDA explains its slowness with a high probability of dangerous complications, first of all, the formation of teratomas (tumors consisting of several types of embryonic tissues) possible with failures of stem cell differentiation.
However, according to the developers, the risk of such a development is extremely insignificant. In the damaged areas of the spinal cord of patients, not embryonic cells will be injected, but the progenitor cells of oligodendrocytes obtained from them – cells responsible for the formation of the myelin sheath of neurons. It is assumed that an increase in the number of these cells will create favorable conditions for the regeneration of damaged nerve fibers, which, in turn, will lead to the restoration of sensitivity and mobility of paralyzed limbs. So far, this effect has been achieved during laboratory experiments on rats with spinal injuries. Serious undesirable consequences, including the degeneration of stem cells into tumors, were not recorded.
Have the changes come?However, until recently, the slowness of the FDA was far from the main problem of cellular technologies in the United States.
A much more serious obstacle to the development of stem cell medicine was the policy of the George W. Bush administration, which relied on the fervent support of influential religious fundamentalists in America.
One of the main ideas of the fix of a number of the largest religious associations in the United States is the fight against abortion. Since, from the point of view of most theologians, a person becomes a person at the moment of the fusion of an egg and a sperm, religious moralists are attacked not only by abortions allowed in the early stages of pregnancy, but also by "abortive" contraceptives that remove an already fertilized egg from the uterus, as well as methods of in vitro fertilization (IVF) involving embryo selection.
Unfortunately for American scientists, the source of embryonic stem cells are embryos screened out during IVF. As a result, in 2001, a law proposed by Bush Jr. was passed in the United States, which deprived all scientific institutions that used cells obtained by destroying embryos of state funding. Researchers counting on state support were allowed to work with only a few dozen cell lines that were created before 2001. Despite repeated attempts to repeal or revise the odious law, it lasted until the last days of the Bush presidency.
Barack Obama, who replaced George Bush in the White House, also voted for the revision of the stem cell law as a senator. During the election campaign, the future president spoke very cautiously on this issue, promising to abolish unnecessary restrictions that prevent scientists from doing their job, and at the same time maintain strict control over the ethical side of biomedical research. The desire of the future president to preserve the feelings of religious voters is quite understandable, so most observers are confident that after the change of power in Washington, the days of religious prohibitions in science are numbered.
It should be noted that Geron's cellular preparations were obtained on the basis of those few stem cells that the 2001 law left at the disposal of scientists, so there were no formal obstacles to continuing the study even under the former US president. In addition, the FDA makes decisions independently of other federal structures, and formally is absolutely not obliged to take into account the opinions, sympathies or electoral obligations of the first person of the state. Nevertheless, the long-awaited decision of the FDA looks like a kind of inaugural gift to Obama.
Competitors and charlatansDue to the ethical and religious problems of American science, individual researchers, biotech companies and investors were forced to look for new ways of development outside the United States.
A few days before the FDA, permission to conduct an experimental study on the treatment of the effects of stroke with stem cells was issued in the UK. However, in the British experiment, fetal stem cells, which have less therapeutic potential, will not be used, but fetal stem cells.
Meanwhile, stem cell medicine is rapidly developing in a number of non-European countries, which lack a developed system of supervision of biomedical activities. There are dozens of clinics in China, India and Brazil offering everyone to be treated with stem cells, including embryonic ones. However, serious international scientific organizations are skeptical about the activities of Asian and Latin American colleagues, and warn patients about the uselessness and danger of scientifically unconfirmed treatment methods
And what about Russia?The General Director of the Institute of Human Stem Cells Artur Alexandrovich Isaev told the media about the development of cellular technologies in our country.
According to Isaev, currently there are no clinical trials of techniques based on cellular technologies in Russia, not to mention the therapeutic use of embryonic stem cells. Some time ago, Roszdravnadzor refused to extend the registration of the only study in recent years using hematopoietic (adult) stem cells, which was conducted in one of the medical centers in Moscow. The position of Roszdravnadzor is due to the lack of an established procedure for issuing permits for the use of cellular technologies in clinical practice. In this regard, the federal agency agrees to register only laboratory methods of collecting and storing stem cells, but is not ready to authorize full-fledged clinical trials with the participation of patients. Bureaucratic delays with the registration of cellular technologies in Russia have already led to several court proceedings with Roszdravnadzor, which ended in favor of the plaintiffs, Isaev notes.
Prospects for allMeanwhile, in developed countries, dozens, if not hundreds of techniques based on the use of embryonic stem cells are at the stage of preparation for clinical trials.
Therefore, there is every reason to hope that the long-awaited decision of the FDA will pave the way for a whole series of similar studies, and that some of them will eventually help to defeat previously incurable diseases.
Changing the position of the most authoritative supervisory authority in the world will speed up the process of registration of cellular technologies in other countries as well. So sooner or later, foreign achievements will become available to Russian patients. Scientific progress is an irreversible phenomenon, and neither religious fanatics nor bureaucrats can stop it.
Portal "Eternal youth" www.vechnayamolodost.ru
26.01.2009