Researchers and entrepreneurs have developed an implant made of collagen protein from pig’s skin, which resembles the human cornea. In a pilot study, the implant restored vision to 20 people with diseased corneas, most of whom were blind prior to receiving the implant. The study jointly led by researchers at Linköping University (LiU) and LinkoCare Life Sciences AB has been published in Nature Biotechnology. The promising results bring hope to those suffering from corneal blindness and low vision by providing a bioengineered implant as an alternative to the transplantation of donated human corneas, which are scarce in countries where the need for them is greatest.
“The results show that it is possible to develop a biomaterial that meets all the criteria for being used as human implants, which can be mass-produced and stored up to two years and thereby reach even more people with vision problems. This gets us around the problem of shortage of donated corneal tissue and access to other treatments for eye diseases,” says Neil Lagali, professor at the Department of Biomedical and Clinical Sciences at LiU, one of the researchers behind the study.
An estimated 12.7 million people around the world are blind due to their corneas, which is the outermost transparent layer of the eye, being damaged or diseased. Their only way of regaining vision is to receive a transplanted cornea from a human donor. But just one in 70 patients receives a cornea transplant. Furthermore, most of those who need cornea transplants live in low and middle-income countries in which access to treatments is very limited.
“Safety and effectiveness of the bioengineered implants have been the core of our work, says Mehrdad Rafat, the researcher and entrepreneur behind the design and development of the implants. He is an adjunct associate professor (senior lecturer) at LiU’s Department of Biomedical Engineering and founder and CEO of the company LinkoCare Life Sciences AB, which manufactures the bioengineered corneas used in the study.
“We’ve made significant efforts to ensure that our invention will be widely available and affordable by all and not just by the wealthy. That’s why this technology can be used in all parts of the world,” he says.
The cornea consists mainly of the protein collagen. To create an alternative to human cornea, the researchers used collagen molecules derived from pig skin that were highly purified and produced under strict conditions for human use. The pig skin used is a byproduct of the food industry, making it easy to access and economically advantageous. In the process of constructing the implant, the researchers stabilized the loose collagen molecules forming a robust and transparent material that could withstand handling and implantation in the eye. While donated corneas must be used within two weeks, the bioengineered corneas can be stored for up to two years before use.
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