Russia has begun clinical use of a pioneering cell-based technology to repair damaged eardrums, in what is being described as the world’s first clinical application of a cell-based medicinal product (CBMP) for tympanic membrane regeneration. The innovation, developed at the Clinical Centre of IM Sechenov First Moscow State Medical University (Sechenov University), marks a major milestone in regenerative medicine and ear surgery.
World-first use of cell-based graft for eardrum
Sechenov University’s Clinical Centre is now performing eardrum repair procedures using tissue equivalents created from patients’ own cells. According to the university, this is the first time globally that a CBMP has been used in clinical practice specifically to regenerate the tympanic membrane.
Rector Petr Glybochko said Sechenov is the only medical university in Russia to have completed the full translational pathway “from fundamental research to certified production of a cell product and its clinical use” within its own facility, supported by state science and education programmes.
How the new procedure works
The technology involves extracting cells from a patient’s adipose (fat) tissue and forming them into tiny 3D clusters called cell spheroids. These spheroids are then implanted at the site of the perforated eardrum together with a resorbable membrane scaffold.
Over time, the membrane dissolves and is replaced by the patient’s own regenerated tissue, which closely mimics the structure and function of a natural tympanic membrane. Clinical data from the centre show that the operation takes around 40 minutes, substantially shorter than conventional tympanoplasty procedures.
Faster surgery, promising early results
Early clinical experience has been “encouraging”, with the first patients showing favourable post‑operative recovery and no reported complications so far. Surgeons and researchers say the approach could improve consistency and durability of repair compared with existing techniques, which are technically demanding and may fail in 10–20% of cases.
Current tympanoplasty often utilises grafts such as fascia or cartilage; however, these do not always integrate predictably or restore full function, resulting in residual hearing loss or reperforation in some patients. The new cell-based method aims to create living tissue that is biologically closer to the original eardrum.
Addressing a common but under-recognised problem
Tympanic membrane perforation affects an estimated four to five people per 1,000 and is commonly caused by chronic ear infections, physical trauma, or sudden pressure changes. Untreated perforations can lead to hearing loss, recurrent infections and reduced quality of life.
By simplifying and shortening surgery, and potentially improving graft stability, the Russian team hopes the new technique will expand access to effective treatment and reduce complication rates.
Platform for wider regenerative therapies
Researchers at Sechenov University stress that the project covers the full innovation cycle, “from cell isolation to clinical application,” signalling a shift from experimental work to practical medicine in the field of cell therapies.
They add that the platform could eventually be adapted for regenerating other organs and tissues, significantly broadening the future scope of cell-based treatments beyond otology to wider applications in regenerative medicine.
