Cell forecast: Russia will start producing eardrums and nasal septums
This year, Sechenov University will launch the production of personalized biomedical cell products for the restoration of vocal folds, eardrums and nasal cavity structures. As scientists told Izvestia, therapy with such products is less traumatic than traditional methods and allows to restore tissues almost to their original state. On how the treatment of the new technology, read in the material "Izvestia".
What are biomedical cell products
Sechenov University will launch in 2025 the production of personalized biomedical cellular products (BMCP). The university told Izvestia that BMPCs for the restoration of vocal folds and eardrums are now fully ready for use in clinical practice.
The procedures for patients who will be recommended treatment with the use of such technologies are almost the same as they are now. They will need to see a doctor and undergo an examination, just as they would in preparation for any other surgery. If there are no contraindications, a small fragment of fatty tissue will be taken from the patient at the Clinical Center for the fabrication of the BICP. Once the doctor receives the finished product, he will inject it into the patient's body during surgery - for example, in the form of an injection.
The entire cycle from doctor's consultation to surgery will take four to six weeks and will depend mainly on how quickly the patient passes all the tests.
Mikhail Svistushkin, Candidate of Medical Sciences, Associate Professor at the Department of Ear, Throat and Nose Diseases of Sechenov University
- Cells are a very sensitive material, they die if manipulated for long periods of time without special conditions, so the production and transportation of BMSCs simply cannot be long. In general, nothing changes for the patient in principle: he goes to the clinic, undergoes examination and receives treatment," Mikhail Svistushkin, candidate of medical sciences, associate professor of the Department of Ear, Throat and Nose Diseases of Sechenov University, told Izvestia.
Biomedical cellular product (BMPC) is a "cocktail" of human cells and auxiliary components: drugs or medical devices. BMPCs allow accelerating healing processes, increasing the patient's chances of full recovery in case of injuries, various diseases, and after surgeries. Treatment using natural material - human cells - in many cases can be safer and more effective than other methods.
Research aimed at developing cellular products has been conducted at Sechenov University since 2016, when the Institute of Regenerative Medicine was founded. In 2024, a number of legislative changes came into force that simplify the registration of BICPs, which made it possible to start their production. According to Pyotr Timashev, scientific director of the Biomedicine Science and Technology Park (NTPB), during this time scientists have worked out the technology for the production of spheroids - "spheroids" made of patient cells that secrete a cocktail of biologically active substances: growth factors, anti-inflammatory factors.
- They act as a regulator of regeneration and stimulate the formation of not scar tissue, but one that will be close to normal. The researchers also created bioequivalents for the replacement of the eardrum and vocal cords and conducted a number of experiments on animals that demonstrated the effectiveness of such therapy," the specialist said.
Production of cellular products will be organized on the basis of clean rooms of NTPB. Biobank specialists will take care of logistics, who will carry out the initial evaluation and registration of biomaterial, provide incoming control and transfer selected samples to production.
Why bioengineered eardrums are needed
In the case of the vocal folds, the treatment will help to get rid of scars on them that have formed due to diseases, injuries in the neck area, surgeries and other reasons. Such scars can not only lead to partial or complete loss of voice, but also block the laryngeal lumen, so that the patient will need to apply a tracheostomy (created by the surgeon to connect the tracheal cavity with the environment to restore breathing bypassing the nose and throat). At the same time, there is no technology that can completely get rid of the scar.
Damage to the eardrum most often occur after otitis media, said the scientists. A hole in the membrane becomes an entry gate for infection, which leads to exacerbation of chronic otitis media, suppuration and pain. Tympanoplasty, which uses fragments of the patient's own cartilage or cartilage, is now used for repair. It allows to close the hole, but does not allow to restore hearing - the membrane does not vibrate like a healthy one and does not conduct sound sufficiently. In addition, such an operation requires high qualification of the doctor.
Scientists tested cellular products for eardrum restoration on chinchillas - their eardrums are most similar to human eardrums in size and structure. After a month, the eardrum had fully recovered and began to transmit vibration in the same way as the native one.
The scientists' future plans include working on BICPs for repairing nasal cavity defects. Septal perforations, "empty nose syndrome" and other disorders bring patients serious problems, up to disability, the university said.
What will give the production of cell products in the Russian Federation
The launch of production is certainly good news, because in case of success and efficiency of BICP developments and their application, many patients will be able to avoid disability, Andrey Lomonosov, deputy head of the NTI HealthNet working group in the direction of "Biomedicine", scientific consultant of R-Pharm JSC, told Izvestia.
- It is precisely such platforms that implement new regulatory regimes thatenable cell technologies to develop in our country not only at the level of research, but also to be directly applied and really help. The visible result will expand the acceptance and further development of products of this type," the expert said.
According to him, the areas where production will start are clinically demanded and effective: for example, there is scientific evidence that one procedure of cell product application is enough to correct ear septum defects that require such treatment. There are many other applications in regenerative medicine, said Andrei Lomonosov.
Theuse of autologous, i.e. cells and spheroids based on them taken from a particular patient, is promising, said Albert Rizvanov, head of the Center of Excellence "Personalized Medicine" of Kazan (Volga Region) Federal University, corresponding member of the Academy of Sciences of the Republic of Tatarstan.
- Their use does not lead to rejection of such grafts," the specialist emphasized.
Scientists of the Institute of Regenerative Medicine are also working on the creation of a preparation for the restoration of extended defects of tubular organs of the urinary tract. Employees of the Institute of Regenerative Medicine are already investigating the effectiveness of BICP for the restoration of the ureter on animals. Clinical trials are planned for 2026.
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