The New SVF-Based Regenerative Approach: A Patient-Derived Cell Therapy

The essence of the new method centers on using cells harvested from the patient’s own fat tissue. A small amount of subcutaneous fat, roughly 100 milliliters, is collected and processed under sterile conditions in a dedicated laboratory. This process yields the stromal vascular fraction, or SVF, which is then reintroduced into the patient to stimulate tissue regeneration. The entire procedure can be performed with local anesthesia, and it may be done on an outpatient basis or in a day hospital setting.

What cells make up this fraction? Early work dating back to 2001 identified multipotent mesenchymal stromal cells in adipose tissue, which share notable similarities with bone marrow cells in their regenerative properties. Fat tissue contains far more stromal cells per unit volume than bone marrow. The SVF is valued for its regenerative potential because of its easy production and distinct mix of cells. Besides the mesenchymal stromal cells, SVF includes cells lining blood vessels, smooth muscle cells, tissue macrophages, and leukocytes.

The mechanism by which stem cells, including MMSCs, exert their effects involves the secretion of a broad range of growth factors that primarily promote new blood vessel formation. What makes SVF unique is that both MMSCs and the target cells for growth factors are present within a single product, and their combination is naturally suited to each patient since these cells are not artificially created. The product retains its properties during production and remains consistent as the material expands.

How are the necessary cells extracted from fat? There are two approaches: enzymatic digestion and mechanical processing. Each method takes about forty minutes and can be performed in a specialized laboratory or in the operating room if the proper medical devices are available.

In enzymatic digestion, a specialized enzyme is added to break down connective tissue and the membranes of adipocytes. The adipocytes do not participate in regeneration, leaving behind the SVF. Mechanical processing, on the other hand, involves repeated crushing and grinding using mechanical forces in devices such as sieves, mills, grinders, and filters.

Under the federal project Medical Science for People, these efforts are advancing toward fully domestic medicinal products for both enzymatic and mechanical production of SVF, including the use of a Russian enzyme.

What is the current stage of development? The enzyme has been assembled, with aims to replace costly foreign analogues. Producer strains have been selected, laboratory production and purification processes have been developed, experimental batches have been produced and benchmarked against leading Western enzymes, and the Russian variants have shown superiority in several indicators.

At present, a production line is being built at a Russian biotechnological facility to scale the laboratory work. The goal is to complete all processes and obtain a registration certificate within the coming year.

Has a device for mechanical processing of fatty tissue been created? Prototype development is complete, and laboratory testing is underway through December. Collaboration with Bauman University physicists has enabled simulations of device prototypes based on detailed calculations. Testing on adipose tissue samples is ongoing to refine the system, and the final device design is expected to be chosen by year-end with pre-production samples planned for the first or second quarter of the next year. Registration is anticipated in the middle of the following year.

What exactly is this device? The prototype is a disposable tool featuring a grater and a mesh system housed in a closed chamber. The surgeon places it between two syringes and pushes the fatty tissue through to obtain the therapeutic product. This method can be learned by a surgeon in roughly ten minutes, with no special expertise required. Efforts are underway to standardize the workflow so surgeons can apply the technique without deep specialization. An automatic version is also being developed to ensure consistent product quality under standard conditions, with a guarantee attached.

The overarching aim is to make the SVF technology accessible to a broad spectrum of specialists and patients across Russia. While the mechanical method yields fewer target cells and preserves parts of the fat matrix, it can aid tissue regeneration and address minor soft tissue volume deficits, which is relevant for closing fistula tracts. Consequently, this form of SVF therapy is suitable for topical use rather than intravenous administration.

Regarding applications, four studies are underway to assess efficacy in knee joint arthrosis. Initial patient enrollment began in April, with fifty participants monitored for six months. The current phase involves final visits and functional assessments across several scales, with MRI data used to evaluate cartilage repair. Early results are optimistic, with more than nine in ten patients reporting improved function and reduced pain.

Why does cartilage heal after SVF placement in the knee? When these cells are introduced to a damaged area, blood flow to the surrounding tissue improves quickly, supporting natural regeneration. In arthrosis, chronic inflammation and cartilage destruction disrupt nourishment from the underlying bone. Cartilage lacks its own blood vessels and relies on the bone beneath. SVF stimulates blood flow to the bone tissue, restoring cartilage nutrition, while the bioactive molecules produced by SVF reduce inflammation, creating favorable conditions for cartilage regeneration.

Are there conditions that cannot be treated with this approach? For example, if limb alignment is severely distorted, or if the damaged cartilage area exceeds five square centimeters, cell therapy may be ineffective. These limits are also reflected in foreign literature and ongoing verification is taking place.

Is fracture repair possible with this cell therapy? Yes. The treatment can support fractures with delayed healing and the formation of nonunion bones. It can also be used to treat avascular necrosis of the femoral head. The same basic process is followed across conditions: collect tissue, process it into a cellular product, and inject into the affected area. If there is a need to promote callus formation in a difficult case, or to target a joint cavity, the approach can be applied accordingly.

Research is expanding to Crohn’s disease complications, notably perianal fistulas. The therapy is not used to treat Crohn’s disease itself but to address these complications. Subcutaneous injections around the fistula tract show regenerative potential, and fistulas have demonstrated healing in trials. Recruitment of patients continues with plans to assess dosing frequency in ongoing studies. A parallel study of rectovaginal fistulas after radiation therapy has yielded highly favorable results, approaching near total effectiveness.

Beyond these conditions, the potential applications span many ischemia-related conditions. Chronic inflammation with connective tissue proliferation often reduces blood supply, so SVF could influence multiple pathologies that share this common thread. Foreign literature outlines more than a hundred possible targets, all requiring verification. Could coronary artery disease be treated in this way? It remains a research question, with animal studies and careful monitoring of unpredictable cardiac responses essential before any human application. There is also potential to improve blood flow to the lower extremities in chronic ischemia, a serious problem deserving exploration. The field holds promise, but definitive results require time, careful study, and ongoing evaluation of safety and efficacy.