Clinical trials of liquid cornea, which can end the dependence upon human cornea donors for the treatment of corneal blindness, are likely to begin in Japan in the near future.
"The clinical trials are expected to begin in Kyoto, Japan, within a few months, in collaboration with a team of Prof Shigeru Kinoshita from Kyoto University, with the aid of Indo-Japanese grant, and with the approval of the pharmaceuticals and medical devices regulatory authority in that country," said Dr Virender Singh Sangwan, an acclaimed ophthalmic surgeon behind the path-breaking research.
Dr Sangwan, a recipient of Dr Shanti Swarup Bhatnagar Award and president of Asia Cornea Society, was in Rohtak to attend the Third Research Conclave of Pt Bhagwat Dayal Sharma University of Health Sciences (UHS).
Talking to "The Tribune", he said liquid cornea was a ray of hope for millions of corneal blind persons who depended on human cornea donors. “The number of corneal blind persons is much higher than that of cornea donors. Moreover, the donated cornea cannot match the shape of a patient’s eye, and can also be rejected by the patient’s immune system,” he pointed out.
The demand for donor corneas significantly exceeds the supply, with more than 12 million people estimated to be waiting for a corneal transplant.
“The liquid cornea is designed to stimulate the repair and regeneration of damaged corneal tissue. It comprises cell-derived vesicles known as exosomes, which have enhanced regenerative properties,” he explained.
Pandorum Technologies, a biotechnology company working in the domain of tissue engineering and regenerative medicine, is collaborating with clinical partners in the US and India to prepare for the human trials of liquid cornea.
In India, Dr Sangwan is leading the clinical study at Dr Shroff’s Charity Eye Hospital in New Delhi.
The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research has designated liquid cornea, Kuragenx, as a combination product and recently granted it orphan drug designation for treating advanced neurotrophic keratopathy, a severe degenerative corneal disease caused by impaired corneal sensory innervation.
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