Sechenov University will commence the production of biomedical cell products.

Step into the Future

A biomedical cell product (BMCP) is a "cocktail" made from human cells and auxiliary components such as medications or medical devices. BMCPs facilitate faster healing processes, increasing the patient's chances of full recovery from injuries, various diseases, and post-surgery. Treatment using natural materials—human cells—can often be safer and more effective than other methods.

Research aimed at developing cell products has been conducted at Sechenov University since 2016, when the Institute of Regenerative Medicine was established. According to the scientific supervisor of the NTBP, Pyotr Timashev, during this time, scientists have developed a technology for producing spheroids—"balls" made from the patient's mesenchymal stromal cells, which release a cocktail of biologically active substances: growth factors, interleukins, and anti-inflammatory factors. These substances act as regulators of regeneration and stimulate the formation of non-scar tissue that closely resembles normal tissue. Researchers have also created bioequivalents for replacing the eardrum and vocal cords, conducting a series of experiments on animals that demonstrated the effectiveness of this therapy.

In 2024, amendments to federal law 180-FZ "On Biomedical Cell Products" came into effect, allowing the use of BMCPs at the Clinical Center of Sechenov University.

The production of cell products will be organized at the cleanroom facilities of the Biomedicine Science and Technology Park. The requirements for the creation, storage, and transportation of BMCPs are very strict—ranging from temperature control to the equipment used in storage and production facilities, whose cleanliness must be validated by appropriate methods. The logistics will be handled by specialists from the Biobank, who will conduct initial assessments and registrations of biological material, ensure incoming quality control, and transfer selected samples for production. Additionally, the Biobank will store control samples and informed patient consents.

From Doctor's Visit to Surgery—Just Over a Month

The procedures for patients recommended for treatment with BMCPs will remain largely unchanged. The patient will still need to consult a doctor and undergo examinations, just as with preparations for any other surgery. If there are no contraindications, a small fragment of adipose tissue will be taken at the Clinical Center for the production of the BMCP. Once the doctor receives the finished product, it will be administered to the patient during the operation—such as through an injection.

The entire cycle from the doctor's consultation to surgery will take four to six weeks, primarily depending on how quickly the patient completes all necessary tests.

"Cells are very sensitive to external conditions; prolonged manipulations without special conditions can lead to their death. Therefore, the production and transportation of BMCPs cannot be lengthy. Overall, nothing fundamentally changes for the patient: they visit the clinic, undergo examinations, and receive treatment," explained Mikhail Svistushkin, a candidate of medical sciences and associate professor at the Department of Ear, Nose, and Throat Diseases at Sechenov University.

The key difference will be the surgery process and its outcome: therapy using BMCPs is less traumatic compared to traditional methods and allows for not just closing the defect but restoring tissues to near-original conditions. According to Mikhail Svistushkin, many of his patients are already aware of these developments and are very interested in the possibility of receiving cell therapy.

From Eardrum to Urethra

Currently, BMCPs for the restoration of vocal cords and eardrums are fully ready for clinical practice. In the first case, the treatment will help eliminate scars on the vocal cords that have formed due to illnesses, neck injuries, surgeries, and other reasons. Such scars can lead to partial or complete voice loss and can obstruct the laryngeal lumen, necessitating a tracheostomy. However, technologies that allow for the complete removal of scars are still lacking.

Experiments on laboratory animals confirmed that BMCPs for restoring vocal cords indeed facilitate the formation of tissue at the scar site that is virtually indistinguishable from native tissue. Moreover, the surgical technique is less traumatic than traditional interventions.

Eardrum perforations often occur after otitis media. A hole in the eardrum serves as an entry point for infections, leading to exacerbations of chronic otitis, pus drainage, and pain. Currently, tympanoplasty is used for restoration, which involves using fragments of the patient’s own cartilage or perichondrium. While this procedure can close the hole, it does not restore hearing effectively—the eardrum does not vibrate as a healthy one would, and it does not transmit sound adequately. Additionally, such surgeries require a high level of expertise from the surgeon.

Scientists tested BMCPs for eardrum restoration on chinchillas, whose eardrums closely resemble human ones in size and structure. A month later, the eardrum was fully restored and transmitted vibrations just like a native one.

Unlike existing methods today, the technology using bioequivalents is very simple—just refreshing the wound edges and placing a "patch" with the bioequivalent on a collagen substrate is sufficient. This makes the operation much faster than traditional tympanoplasty.

Future plans for researchers include working on BMCPs for restoring defects in nasal cavities. Perforations in the septum, "empty nose syndrome," and other disorders pose serious issues for patients, potentially leading to disability. Treatment options are extremely limited, and there are very few doctors qualified for the delicate work of restoring affected structures.

Additionally, specialists from the Institute of Regenerative Medicine are working on creating BMCPs for restoring extensive defects in the tubular organs of the urinary tract. Damage to the urinary tract due to trauma or inflammatory processes often leads to narrowing, causing severe pain and difficulty in urination. Currently, complex methods, including tissue transplantation from the patient, are used for restoration. However, such surgeries are traumatic, require long recovery times, and are not suitable for all patients.

"First, a supportive surface—a collagen membrane—is created, which will be sutured to the ureter. Next, a cellular component based on the patient's biomaterial is applied to the membrane. This tissue-engineered construct is then implanted into the patient during surgery," explains scientific supervisor Pyotr Timashev, emphasizing that the resulting cell product functions similarly to the bioequivalent of the eardrum: it allows for the replacement of damaged tissues and, as the membrane is absorbed, facilitates the formation of new tissues that provide the organ with necessary functionality. According to the scientist, this technology can be used for reconstructing other types of flat epithelial tissues.

According to Pyotr Timashev, staff at the Institute of Regenerative Medicine are already investigating the effectiveness of BMCPs for ureter restoration in animals. Clinical trials are scheduled for 2026.