Treatment of degenerative joint disease (arthritis, osteoarthritis, degenerative disc disease, arthritis, etc.) using cellular technology.


    According to statistics, diseases of the joints affects roughly one in three people in the world. The prevalence of this disease is ahead of many well-known diseases and in advanced stages it causes a lot of suffering to patients, leading to a temporary disability and often to total disability. In our time, there are more and more reasons for the occurrence of diseases of the joints, such as poor environment, malnutrition and inadequate food, leading to obesity, lack of exercise, or vice versa hectic lifestyle, genetic predisposition, etc.
    Despite the rapid development of medicine, to date, the problem of effective treatment of diseases of the joints is not solved. Cartilage due to its structure have a low metabolic rate. Due to lack of blood vessel regeneration in them is at minimum level and is carried out mainly by the perichondrium. Hyaline cartilage that covers all of the joint surface, is devoid of perichondrium, so self-healing of damaged hyaline cartilage is almost impossible.
  Therefore, in practice there is an urgent need for orthopedics in the creation of innovative effective technology for the treatment of diseases of the joints. In recent years, thanks to the rapid development of biomedicine, there was a scientific and practical basis for the development of treatments for many diseases with the use of cellular technologies.

Innovative approaches

   To date, cell therapy and tissue engineering are the most promising areas of biomedical science. With the development of these sciences is possible to recover the lost of the functional properties of tissues and organs damaged. In the body the renovation and restoration of tissue is due to stem cells, which are undifferentiated progenitor pool of spare cell types. Therefore, technologies that use the body's own resources (identified and propagated in vitro in the adult stem cells) in medicine to repair damaged tissues and organs, no doubt, perform an innovative approach to develop effective treatments for many diseases and, in particular, disease of the joints.

The technology

   The basis of the technology, to restore the disturbed functions of joints, established by the experts of the Cell Technologies Center, Beauty Plaza Ltd., lay the unique ability of stem / multipotent cells to repair damaged tissue and organs. As a result, is created an effective, safe, low-impact way to treat degenerative joint disease, which is supposed to use the body's own resources. The method consists of intraarticular injection of the graft consisting of equity or allogeneic cell material and the carrier. To achieve the best results by experiment there was selected optimal combination of cellular material and the carrier. As cellular material were used multipotent mesenchymal stem cells (ITCs) of adipose tissue. Adipose tissue is the most accessible and versatile, as it can be pretty easy got outpatient using local anesthesia from any person, or during planned or plastic surgery. These cells have unique characteristics: the ability to proliferate for a long time in culture and under certain conditions turn into cartilage cells. As the carrier is used biodegradable sterile gel, similar in consistency to the synovial fluid that fills the joint, which when ingested is absores into the fabric, and then eventually exudes out of the body without causing systemic toxicity, allergenic and topical irritation.

Research supporting the effectiveness and biosecurity of technology

    а) studies in vitro
   In vitro studies were carried out in the laboratories of the Cell Technologies Center, Beauty Plaza Ltd. Methods of preparation of ITCs from various sources (fat, thymus, bone marrow, placenta). A method of obtaining ITCs from adipose tissue obtained Russian, U.S. and European patents.
RF patent "Method of isolation of mesenchymal stem cells» № 2252252, priority of invention April 9, 2004United States Patent «Method for obtaining mesenchymal stem cells» № 7915039 B2, priority of invention March 29, 2011European Patent «Method for obtaining mesenchymal stem cells» № EP 1733027 B1, priority of invention December 28, 2011
   As a result there were obtained derived cell lines of adipose tissue for transplant. Was fully explored the potential ability of these cells to form cartilage. The cell lines were characterized by flow cytometer at the Acad. MM Shemyakin Ovchinnikov Institute of Bioorganic Chemistry Sciences and the Central Research Institute of Epidemiology. The effect of different media (saline, collagen, hyaluronic acid, etc.) on hondropotentsii cells. By the experimental way there was chosen the optimal carrier for transplantation of cellular material in the joint.
    б) studies in vivo
  In vivo study was performed at the Institute of Experimental Diagnosis and treatment of tumors of the NN Blokhin Russian Cancer Research Center. In experiments with athymic mice was established cellular material safety data and media.
    в) pre-clinical research
    The pre-clinical trials of the technology were conducted in the KI Scriabin Federal State "Moscow State Academy of Veterinary Medicine and Biotechnology and Russian Scientific Research institute of livestock. In large-scale trials have been involved small (rabbits) and large (sheep) farm animals. The result confirmed the high efficiency of the method.
    г) clinical studies
   DE FACTO: Clinical trials of biomedical technologies were developed on 98 volunteers, with their informed consent.
    The result proved that the proposed method for the treatment of degenerative diseases of different etiology and localization has a very high efficiency grade on the regeneration of hyaline cartilage tissue, which leads to the restoration of the lost function of the joint.
According to the results we obtained the patent of the Russian Federation "The regeneration of cartilage hyaline tissue of the joints in the early stages of destructive diseases» № 2452527, priority of December 27, 2010

Existing analogues in Russia and abroad.

    Current research in the search for biotechnological approaches to the treatment of diseases of the joints are actively conducted by scientists the U.S., Belgium, Canada, Germany, Great Britain, Korea, and others. In result, there were obtained the following products for the treatment of diseases of the joints - Sarticel ® (USA), Hyalograft ® (Italy), ACI / MACI /-A, BioSeed ®-C (Germany), ChondroCelect ® (Belgium), Cartistem (Korea). However, due to undoubted value of those products, all of them have significant drawbacks, such as causing additional trauma to a healthy area with withdrawal of cellular material, technical difficulties in building the necessary amount of cellular material for transplantation, which significantly increases the cost of the product, the need for treatment of unwanted cell differentiation inducers before transplantation, which can lead to uncontrolled changes at the molecular level and the formation of fibrous cartilage, etc.Moreover, these techniques involve limiting the load on the joints for 3 months and moving on medical chair.

The procedure for treatment

   According to the results of MRI in 1-2 stages of degenerative process in the joint at any site, a decision to inject patient's own cells - chondrocytes (to fully restore cartilage tissue) is being made. Ambulatory, in the operating room and under local anesthesia patient is takes the adipose tissue harvest procedure (2-3gr.). Own cells, isolated from adipose tissue, immediately enter the sterile laboratory of Cell Technologies Center, Beauty Plaza Ltd, where is held their cultivation and transformation into chondrocytes (cartilage cells) for clinical use for two weeks on the high-quality environments High Clone Technologies. Grown cells are necessarily tested for the absence of bacterial and viral infections, and only after that are used to make cell transplant. Some of the cells are retained in the Bank for future use, using a low temperature freezing (196oS) with cryoprotectants. Then out of the cells and the gel carrier an intraarticular graft is being prepared, using the original method. The introduction of the transplant is performed outpatient by orthopedic surgeon in the operating room, and an hour after the procedure, the patient can return to normal life. The procedure is performed twice with an interval of 3 months.Within 3 months after the introduction of the graft is remarked an active formation of hyaline cartilage in the defect area, but after 6 months, is observed almost complete repair of the articular surfaces, as repeatedly confirmed by computed tomography study of patients already treated.

Recommendations:

    Within 14-18 days after the procedure limiting of sports stress on joints for 3 months and wearing a compression bandage.