Can bio-engineered cornea restore vision? Delhi hospital scores some success with animal trial, is awaiting nod for human trial

‘We have used biomaterials such as collagen, protein and peptide – the building materials of the body – and made the cornea outside the body in the laboratory. A bioengineered cornea’s advantage is that it is not from another human being, so it won’t get rejected when the transplant happens,’ says Dr Virender Sangwan, Director of Innovation, Dr Shroff’s Charity Eye Hospital

According to the WHO, corneal opacity accounts for over four per cent of blindness worldwide, leading to more than 1.5-2 million cases each year. (Image Source; Pixibay)

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Can a cornea be “bio-engineered” or recreated outside the human body with collagen protein from animal sources, implanted in the eye cavity and restore vision? A year ago, a team of researchers at Linköping University (LiU), Sweden, managed to restore the vision of 20 volunteers in a pilot study that used a cornea implant made out of collagen collected from pig skin. Now the Delhi-based Dr Shroff’s Charity Eye Hospital, which has already conducted animal trials, is looking to conduct its own human trials. If successful, this regenerative implant could hold out hope as an alternative to donated human cornea, which may be scarce and not available on time.

“In layman terms, a bioengineered cornea means that the cornea has been created outside the body. We have used biomaterials such as collagen, protein and peptide – the building materials of the body – and made the cornea outside the body in the laboratory. A bioengineered cornea’s advantage is that it is not from another human being, so it won’t get rejected when the transplant happens. It does not have the rejection potential which donor corneas have. Also bioengineered corneas are not limited in supply like donor corneas are,” says Dr Virender Sangwan, Director of Innovation, Dr Shroff’s Charity Eye Hospital. The team is developing a module with the Bengaluru-based Pandorum Technologies. “Our animal trials (on rabbits) are encouraging with around 80 per cent success rate. We will be able to ascertain success in humans after we begin the trials. This is a first of its kind technology in India which has been made by an Indian company, with the support of an Indian hospital and by Indian doctors and scientists,” he adds.

“At present, the only way to get a cornea for a transplant is through cadaver donors, or from deceased people who had pledged to donate their organs upon death. Unfortunately, 40 per cent of the donated corneas do not meet the standards for a transplant. The fact that our supply of corneas is dependent on donors is our biggest challenge. That’s why we are exploring innovative therapies in the space of regenerative medicine where a human tissue is replaced with artificial cells,” explains Dr Sangwan.

When this bioengineered cornea is applied as liquid drops on the patient’s damaged cornea, it solidifies in less than 10 minutes using visible light and integrates with the patient’s cornea. Inside the solidified matrix, the biopolymer acts as sacrificial material supporting sustained release of exosomes which suppresses inflammation, reverses fibrosis, regenerates nerves and restores corneal thickness. “A bio-printed cornea or liquid cornea will allow patients a chance to regrow damaged corneas with minimal surgical intervention. It doesn’t need any stitching, we don’t need any donor cornea and the drop fills the gap like a liquid in a mould,” adds Dr Sangwan.

According to the WHO, corneal opacity accounts for over four per cent of blindness worldwide, leading to more than 1.5-2 million cases each year. India has a huge burden of bilateral (1.2 million) and unilateral (5 – 6 million) corneal blindness. Each year, the burden increases by 30,000 new cases of blindness. According to the Eye Bank Association of India, more than 1,00,000 corneal transplants are required annually, but only 25,000 are actually done.

While this technology has the potential to address a public health crisis, what matters in the end are costs. Dr Sangwan feels “it is still too early to talk about how expensive a bioengineered cornea will be because human trials are yet to begin. We will be able to ascertain the final costs post that. We will be applying for DGCI approval in the next three to four months. Ultimately our endeavour is that it should not be more expensive than a corneal transplant. When human trials start, we will first perform it on adult patients. If successful there, we will try the procedure on paediatric patients. Our aim is to use it to address all types of corneal scars which are caused by infections and injuries.”

This will impact the public health sector positively because not only will it reduce the waiting list for transplants, it will effectively eliminate corneal blindness.