Cell Sheet from Nasal Mucosa
Middle ear cholestoma is a disease of unknown cause that contribute to such as hear loss, bone destruction, ear discharges, dizziness, facial paralysis. Surgery is the only treatment but usually the normal middle ear mucosa is lost leading to decrease of ventilation which ends up with worsening hear loss and relapses. Because the middle ear is difficult to approach, we developed cell sheet from patients own nose, which mucosa is similar with middle ear and easy to access. By transplanting this cell sheet to the middle ear after surgery, the ventilation was well kept in broad area, preventing complications.
A clinical study was conducted starting in 2014, at Jikei University School of Medicine(Japan) and St. Marianna University School of Medicine(Japan) resulted with high efficacy and no adverse events or complications. Our research group launched an investigator initiated trail in November 2021. Through this trial, we aim to establish highly safe methods and confirm effectiveness. With success, this will be the first product to obtain marketing approval for a regenerative medical product in the otorhinolaryngology field in Japan.