ESK against spinal cord injury: details
Injection from paralysis
Tests of a fundamentally new generation of medicines have begunGalina Papernaya, "Time of News"
For the first time in the history of official medicine, American doctors and biologists performed a transplant of embryonic stem cells to a person with a spinal injury in a rehabilitation hospital in Atlanta.
The California biotech company Geron, which was the first to receive a license to conduct such research a year ago, recently announced the first successful operation. In total, at the first stage of clinical trials of a new drug containing specialized cells – oligodendrocytes (oval-shaped cells with appendages, the main building material of the human central nervous system), injections into the affected areas of the spinal cord will be made to nine patients with fresh injuries received no more than 14 days before the transplant. In the course of long-term in vitro laboratory studies preceding the approbation of the method on humans, scientists managed to restore limb mobility in paralyzed rats.
To reduce the likelihood of dangerous complications, participants will receive experimental injections not simultaneously, but in turn – with an interval of 30 days. Thus, it will take at least nine months to include all the subjects in the experiment. The head of the study, Dr. Richard Fessler, explained that candidates for participation in the trial of a fundamentally new method of therapy were selected according to rather strict criteria. To begin with, it was decided to test the cellular drug on injured people with the absence of anatomical spinal injuries and signs of an inflammatory process in the body. Patients with oncological diseases in their family history were also not allowed to study. The last restriction, albeit indirectly, is associated with the greatest risk of such interventions in the body – uncontrolled degeneration of transplanted embryonic cells. The fact is that oligodendrocytes are already specialized cells that are guaranteed to turn into the necessary tissues of the nervous system. But if in the transplant material (in the test conditions it is recorded that 2 million cells will be transplanted to each patient) there is at least one cell from the so-called stable line that has not yet received specialization, then it will begin to specialize already in the body, and in the most unpredictable way. Scientists can only influence whether a stable embryonic cell turns out to be a cell of nervous tissue or some other, and it is not yet clear to science what laws the specialization of implanted cells in the human body obeys. Thus, with insufficient purification of the transplant material, the patient risks getting a tumor, at best benign, instead of healing.
"It is worth noting that in total there cannot be less than three or four phases in clinical trials of this kind, and the task of the first phase is to check how feasible the proposed method is, how safe it is and what dose of the drug should be administered. The therapeutic significance is determined later, at the second or third stage of trials," Sergey Kiselyov, director of the Human Stem Cell Institute, explained to Vremya Novosti. According to the Russian scientist, it was not by chance that nerve tissue was chosen to start experiments with human stem cells – immunological reactions in it are reduced compared to other tissues, which means that the risk of rejection is minimal. "This technology has a great future in all areas of medicine,– Mr. Kiselyov believes. "As a material for it, "extra" cells remaining in laboratories after the in vitro fertilization procedure are used, that is, there should be no problems with obtaining it."
Commenting on the start of sensational clinical trials, Geron President Dr. Thomas Okarma said that it will take some time to evaluate the effectiveness and prospects of cell therapy: "We are prepared for the fact that in the future we will have to conduct a large number of tests." Recall that his company started working with embryonic stem cells back in 1999 and invested $ 170 million in the development of technology for the restoration of dead nerve tissues. All the years of the company's work, its activities have been severely criticized in the United States by religious organizations. At the end of the summer of this year, a group of plaintiffs, who received the approval of religious activists, tried to challenge in court state support for stem cell experiments. The judge of the District of Columbia upheld the lawsuit and imposed a temporary ban on state funding of experiments with cells obtained from embryonic material, but then this decision was overturned by the US Court of Appeals.
Portal "Eternal youth" http://vechnayamolodost.ru14.10.2010