The Clinical Center of Sechenov University has launched operations to restore the eardrum using equivalents created from a patient’s own cells. This is the world’s first clinical experience using such a biomedical cellular product (BCP) for eardrum regeneration, the university explained. The research is being conducted with the support of the Priority-2030 program of the national project Youth and Children.
Tympanic membrane perforation affects 4-5 people per thousand. It occurs after otitis, injuries, or sudden pressure changes and leads to hearing loss and an increased risk of recurrent inflammation. Standard treatment—tympanoplasty—requires a lengthy, complex operation using fragments of the patient’s cartilage or other tissues, and is not always successful: in 10-20% of cases, the transplanted tissues do not take hold on the first attempt.
The new technology involves isolating stem cells from a patient’s adipose tissue, culturing them into a spheroid structure, and implanting this into the eardrum along with a dissolving membrane scaffold. As the scaffold gradually breaks down, the cells differentiate and organize to form a new eardrum that is structurally and functionally identical to the original.
The first patient, Elena Vasnetsova, told GxP News after the surgery that she feels well. “The postoperative period was comfortable, and I am noting a significant improvement in hearing in my right ear,” she said.
The woman’s problems began with acute purulent otitis, for which doctors had to puncture the eardrum to drain pus and install a ventilation tube. However, the very next day after discharge, an acute reaction to topical drops developed, the tissues around the tube were destroyed, and it migrated into the middle ear. After its removal, a persistent large perforation formed, which never healed on its own. Traditional approaches, including double treatment of the perforation edges and application of a collagen hemostatic sponge, were ineffective: the tissues scarred but did not close.
“The surgery takes about forty minutes—significantly less than with classical tympanoplasty. The operated patients have a favorable postoperative course. For the first patient, complete healing and elimination of the perforation were confirmed after three weeks,” said Valery Svistushkin, Director of the Clinic for Ear, Throat, and Nose Diseases at Sechenov University, Professor.
The operations became possible thanks to the development of a platform technology, noted Petr Timashev, Scientific Director of the Institute for Regenerative Medicine at Sechenov University, Professor. “In the near future, we plan to use similar bioequivalents for restoring vocal folds and nasal cavity structures, and later for the urethra and other tubular organs,” he said.
Sechenov University has completed the journey from fundamental research to certified production of a cell product and its application in its own clinic, said the university’s rector, Academician of the Russian Academy of Sciences Petr Glybochko. “These are new opportunities for thousands of patients and proof that Russian science is capable of creating world-class translational technologies without waiting for imported solutions,” the rector emphasized.
