Project summaries 2020
Overcoming the final hurdle to bringing an eye treatment to patients
A procedure for repairing damage to the eyes is close to being cleared for use in Japan
Chie Sotozono of Kyoto Prefectural University of Medicine and her team really wanted patients to benefit from a procedure they had developed for regenerating damaged corneas. Since the eye conditions are relatively rare, it proved to be very challenging to find a pharmaceutical company willing to invest in the procedure. Instead, she opted to conduct an investigator-initiated clinical trial herself with all the challenges that involved. But before she could embark on the trial, she had to secure the needed funding.
That funding, along with other sources of support, came from AMED. The grant enabled Sotozono’s team to conduct a trial on seven patients. She says the results have been very encouraging, and she hopes the treatment will be approved by Japan’s Pharmaceuticals and Medical Devices Agency this fiscal year.
“Without AMED support, both financial and in other ways, we wouldn’t have been able to get this far,” says Sotozono.
The treatment, known as cultivated oral mucosal epithelial sheet transplantation (COMET), is for treating severe ocular-surface diseases. It involves taking cells from a person’s mouth, growing them in the lab and transplanting sheets of the cultivated cells onto the surface of the eye. COMET is unique in that both the mouth cells and the amniotic membrane they are cultivated on are grafted onto the patient’s eye. The membrane supplements loss of the existing membrane and its flexibility allows it to readily conform to the eye’s curved surface.
Project: Project Promoting Clinical Trials for Development of New Drugs
Researcher: Chie Sotozono
Host Institution: Kyoto Prefectural University of Medicine
AMED Funding: Project Promoting Clinical Trials for Development of New Drugs
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