— Please tell us about the essence of the new method.
“We use cells taken from the patient’s own fat tissue. First, we take a small amount of subcutaneous fat (about 100 ml) from the body and process it under sterile conditions in a special laboratory, obtaining the stromal vascular fraction of the cells (hereinafter referred to as SVF) and introducing it into the body uses the patient as a therapeutic agent that triggers tissue regeneration.The entire treatment procedure can be performed under local anesthesia, on an outpatient basis or as a day hospital.
— What cells does this fraction consist of?
– First in 2001 to work Our foreign colleagues described the presence in adipose tissue of multipotent mesenchymal stromal cells (MMSC), which are very similar to the same bone marrow cells in terms of their properties.
Additionally, fat tissue contains 2500 times more stromal cells per unit volume than bone marrow. The role of SVF as a promising cellular product with regenerative properties is associated with unique therapeutic properties due to the relative ease of production and composition of the fraction. In addition to MMSCs, SVF includes cells in the inner lining of blood vessels, smooth muscle cells, tissue macrophages, and leukocytes.
As is known, the mechanism of action of “stem” cells or MMSCs occurs through the production of numerous growth factors and primarily aims to stimulate the formation of new vessels. Additionally, the uniqueness of SVF lies in the fact that both MMSCs and the target cells for the growth factors they produce are present in a single product, and the combination of these cells is “physiological” for each patient, as neither cell population is created artificially. It increases during the production process and its properties do not change.
— How do you extract the necessary cells from fat?
— There are two approaches: enzymatic digestion and mechanical processing. Both take about 40 minutes and can be done in a specialized laboratory or in the operating room if special medical devices are available.
In the first case, a special enzyme is added to the material, which destroys connective tissue and membranes of fatty tissue cells – adipocytes. These cells do not participate in regeneration processes. As a result, we are left with only SVF.
The second is mechanical processing of fatty tissue when subjected to repeated crushing, grinding, grinding under the influence of various mechanical forces in special devices. These are sieves, millstones, graters and filters.
Within the scope of our developments implemented under the federal project “Medical Science for People”, we are creating completely domestic medicinal products for the enzymatic and mechanical production of SVF, including the Russian enzyme.
— At what stage of development is it currently?
— We have already “assembled” the enzyme; will replace expensive foreign analogues. We selected producer strains, developed laboratory technology for production and purification, produced experimental batches, compared them with the best examples of Western commercial enzymes and made sure that we were superior to them in many indicators.
Now we are building a production line at one of the Russian biotechnological enterprises, that is, we are scaling laboratory technology. Hopefully, next year we will complete all the processes and receive a registration certificate.
—Have you already created a device for mechanical processing of fatty tissue?
— We complete prototype production and carry out laboratory tests in December. Together with physicists from Bauman University, we carried out all the necessary calculations and based on their results we were able to simulate prototypes of the device.
We are now testing them on adipose tissue samples in our laboratory and evaluating all options for the system. We should decide on the final design of the medical product by the end of the year and produce pre-production samples in the first or second quarter of next year. We will need to start registration from the middle of next year.
— What is this device?
— The prototype of the device is a disposable tool with a grater and a mesh system in a closed room. The surgeon places this between two syringes and pushes the fatty tissue to obtain the therapeutic product.
Any surgeon can master this method in 10 minutes. No special knowledge is needed here. As part of our work we are now trying to standardize approaches and relieve the surgeon of the need to dive deeper into the subject. We also produce an automatic device that will ensure that you always receive the product under the same standard conditions, with a guarantee.
We want to make the technology for obtaining SVF available to a wide range of specialists and a large number of patients throughout Russia. Of course, with the mechanical isolation method of SVF we obtain a smaller number of target cells, but such a product contains parts of the fat matrix and, in addition to regeneration, can also repair a small deficit in soft tissue volume, which is important, for example, in closing fistula tracts. This means that it can no longer be administered intravenously, but is only suitable for topical application.
— Now let’s talk about the application of this cellular technology. You are currently conducting four studies; The first is aimed at evaluating the effectiveness of the method in the treatment of knee joint arthrosis. Have you already received your results?
— We started working with the first patient in April. We have 50 of them and we monitor each one for six months. The period in which our first patients complete this six-month observation period is just beginning. They come for final visits, specialists evaluate the functionality of the knee joint on various scales, but most importantly, they objectively evaluate whether the cartilage has been repaired using MRI data. In three to four weeks we will be ready to talk about some general data on effectiveness.
So far the results are very optimistic, patient satisfaction is high; More than 90% of patients reported improvement in functional status and absence of pain.
— Why does the damaged cartilage begin to heal after the cell fraction is placed in the patient’s knee?
“When these cells are placed in any area of the pathological process, adequate blood flow is restored very quickly. This is an important factor in normal regeneration.
In arthrosis, we experience chronic inflammation accompanied by destruction of cartilage and reduced nutrition from the underlying bone tissue. Cartilage tissue is surprising because it does not contain blood vessels of its own, but is extensively supplied by underlying bone tissue.
The introduction of SVF is primarily aimed at stimulating blood flow to the bone tissue, thereby restoring the nutrition of the cartilage. In addition, SVF, or rather the biologically active molecules (cytokines and growth factors) produced by the cells in its composition, reduce inflammation. Thus, conditions are created for the complete regeneration of cartilage.
—Are there any conditions that cannot be treated in this way?
— For example, if arthrosis is accompanied by curvature of the limb axis. We cannot affect physics with cells; If more load is placed on one of the joint surfaces than the other, it will wear out forever. Also, if the total area of cartilage damage exceeds 5 square meters. cm, cell therapy will not be effective in this case. Our foreign colleagues also think so, and we are checking it now.
— Is it possible to treat fractures with this type of cell therapy?
— Yes, that is, fractures with delayed consolidation are the cause of the appearance of false joints, that is, bone fractures that do not heal for a long time. These cells can also be used to treat avascular necrosis of the femoral head.
The technology is the same everywhere: We take tissue, process it, obtain a cellular product and inject it into the area of the pathological process. If we want to overcome aseptic necrosis, either to the place where it is necessary to form a callus, or to the hip joint cavity.
We are also investigating the effectiveness of this type of treatment for complications of Crohn’s disease, an inflammatory bowel disease that is often accompanied by the development of perianal fistula.
— Are the results of arthrosis treatment the same?
“We will complete all our research in these areas in the first quarter of 2024,” he said. Now only 30-40% of patients complete all visits, which is not enough to draw a conclusion.
I would like to point out that we do not treat Crohn’s disease itself, we fight its complications in the form of perianal fistula. These are openings that form near the external anal canal. This is a huge problem and classical surgery still cannot solve it.
However, it can be resolved with cell therapy. We can inject our product subcutaneously around the fistula tract; should promote regeneration. Fistulas are healing.
While we are still recruiting patients, we will observe them next year, divide them into groups, and test the frequency of administration. We conducted a generally similar study with rectovaginal fistulas after radiation therapy. Then we got a very good result; almost one hundred percent efficiency.
— What other diseases can be treated this way?
— It is possible to treat many diseases based on ischemic processes. For example, any scar change, chronic inflammation is accompanied by the proliferation of connective tissue. From the point of view of the body, connective tissue limits such foci so that harmful decay products penetrate the surrounding tissues as little as possible and poison them. Connective tissue is formed precisely in conditions of insufficient blood supply, which is why chronic disease occurs.
It turns out that we can precisely influence the connections of any pathological process based on ischemic damage, that is, lack of blood supply. More than 100 possible areas of application of SVF are described in foreign literature, but all of them need to be verified.
— Can coronary heart disease be treated this way?
– Yes, it is quite possible. However, the heart is an organ where interventions can lead to unpredictable results. Additionally, atypical rhythm foci located in the wrong place may occur, some kind of calcification process, etc. may occur. Of course, this needs to be investigated first in animal models.
— Is it possible to restore blood flow to the lower extremities with the help of such therapy?
— Yes, chronic ischemia of the lower extremities is a serious problem. If we can restore blood flow, we clearly need to do so. We have lots of ideas. This therapy has a great future because its list of applications is wide. But now we must complete our research, look at the results, clearly understand our capabilities and move on.