Regenerative medicine is a rapidly growing trend in science, that uses approaches which allow to grow new cells to replace the dead and for recovery of organ or tissue function. Such methods will be breakthrough in the treatment of cardiovascular, oncological, neurological and other diseases, as well as extensive skin lesions, trauma and burns. This promising area of medical science is supported at the state level. In particular, within the framework of the Federal Targeted Program "Research and development in priority areas of Russian scientific and technological complex for 2014-2020", multipurpose project "Development of technological platform and guidelines for conducting pre-clinical studies of biomedical cell products" is carried out. Leading medical research and educational centers are involved in it.
"We are developing methods for creating drugs based on cells, including stem, which have a great regenerative potential, but because of it, they require very careful handling.
We need not only to show efficiency, but also to check the safety of such drugs. It is not an easy task, because we are talking about the use of human cells, while preclinical studies should be carried out on animals, who obviously will reject such cells upon induction, and to evaluate the outcome of injecting cells will be impossible", - Vsevolod Tkachuk, project manager, academician RAS, dean of the Faculty of fundamental medicine of Lomonosov Moscow State University, says.
Along with this faculty, leading academic institutions in Russia are involved in the project. Many of them also have experience in pre-clinical studies of innovative medicines:
Federal Almazov North-West Medical Research Centre, Russian Cardiology Research and Production Complex, Russian National Research Medical University named after Pirogov, Moscow Scientific Research Institute of Oncology named after Gertsen, Federal Research Center of Transplantation and Artificial Organs named after academician Shumakov, Central Research Institute of Tuberculosis, Centre of Expertise of Medical Products.
All of them are united in a technology platform to develop methods of production of biomedical cell preparations, checking them for biological activity and safety.
The project will be finished at the end of 2016. National guide for leading of pre-clinical studies and proposals for the introduction of new educational programs will be prepared. "We need to train specialists - "cell pharmacists " as well as "cell therapists ", - Vsevolod Tkachuk explained.
During the project, methods for obtaining cell products from stem cells in the heart, bone marrow cells and mesenchymal stromal cells which have properties to cause regenerative processes in damaged organs or tissues, were tested and optimized. Also a range of animal models for estimating the effectiveness of the product were developed under the project. Preclinical studies of human cells were performed in immunodeficient mice having no thymus (so-called nude mice) that did not reject entered foreign cells. In one experiment on animals, hindlimb ischemia was produced by cutting the femoral artery, and then stem cells were injected into a muscle, causing the observed increase of the number of vessels and blood flow improvement.
"These cells are gathering in the area of ischemia and stay there, providing a therapeutic effect, reducing necrosis and causing regeneration of tissue to the end of the second week after the induction," - Vsevolod Tkachuk pointed out.
Human stem cells were taken, of course, by approved manner. "For example, during coronary artery bypass graft, small fragment from human atrial tissue is removed. We take it to isolate stem cells of the heart and produce drug based on them,"- Tkachuk said.
The most important task of the participants of the project is to develop evaluative methods for safe use of cell products.
"The fact is that neither we, nor humanity does not know the remote cell therapy effects in general. At the current stage of development of regenerative medicine to use these technologies without proper supervision is unacceptable and dangerous.
First, these technologies will be used only in the most severe or fatal diseases, where existing treatments do not help," - Tkachuk affirmed.
Stem cells are tested for sterility, absence of impurities (their purity should be at least 90% for certain types of cells), biological activity.
For measuring it, special complex devices and sometimes unique techniques, developed specifically for this type of cells, are used.
It is also important that these cells do not cause increase in temperature, or appearance of tumors. "Some stem cells are quite far removed from the pluripotent cells which can turn nearly any tissue, - Vsevolod Tkachuk said. - Therefore, during their cultivation careful control of states of chromosomes cells and their biological properties is needed - the ability to divide and capacity for differentiation, i.e. "maturation".
Verification of set antigenic markers, search of possible failures in the genome of the cells were conducted during the studies as well as estimation of time of the "life" of the cells in the tissue when they are used for regenerating cartilage, liver, pancreas, or stimulation of vascular growth.
The participants of the project have registered the rules of manufacturing of biomedical cellular products in details in the regulations. Of course, successful international experience in the field of cell therapy was taken into account, but russian researchers believe that transfer it on our soil should not be mechanistically, including the moment, that the national health system have some specific features.