The world's first bioengineered cornea was successfully transplanted in Qingdao

Release date: 2015-12-25

China is one of the most blind countries in the world, and corneal blindness is the second most common blind eye after cataract. According to statistics, there are about 4 million patients with corneal blindness in China, and more than 100,000 cases are added each year. The number of patients who receive surgery each year is less than 5,000, accounting for only 2% of actual needs. Because the source of cornea in the eye bank is scarce, patients can only passively wait for donations.

Ai Xinyi, the world's first bioengineered cornea independently developed by Chinese scientists, is quietly changing the lives of Chinese patients with corneal blindness. Recently, the cornea was deposited in the form of public welfare donation at the Qingdao Eye Hospital of Shandong Institute of Ophthalmology. The director of the Institute and the Chinese Academy of Engineering Xie Lixin implemented the first charity corneal transplant operation. After observation, the patient recovered and stabilized.

Regaining the light, sudden surprise

Wang Xinyi, 61, from a small mountain village in Rizhao County, Shandong Province, suffered from a left eye fungal corneal ulcer and underwent lamellar keratoplasty, becoming the first patient to receive a charitable donation from bioengineered corneal Ai Xinyi.

One day in September this year, Wang Xinyi, as usual, drove a tractor to go to the town not far from home. On the road, he felt that his eyes were suddenly very uncomfortable. He subconsciously rubbed his hand and returned home. His eyes turned red. The next day, the eyes swollen. In the small clinics and county hospitals in the village, the medicines were registered and used, and the condition deteriorated rapidly.

When I came to the Qingdao Eye Hospital, Wang Xinyi’s left eye was already ulcerated. It was necessary to replace the cornea in time, otherwise the eyes would be difficult to keep.

Wang Xinyi’s son thought that his father could no longer see the light again, because there were very few people who donated cornea every year. He did not expect biotech cornea to solve the problem. Moreover, in the clinical trial stage, the efficiency of the bioengineered cornea reached 94.44%, which made him dispel his concerns. He expected the miracle to appear on his father.

On September 25th, Xie Lixin took a knife and performed a bioengineered corneal charity transplant. After the operation, Xie Lixin diagnosed: "The patient still needs a certain period of recovery, the cornea will gradually become transparent, and the vision will get better and better." At present, Wang Xinyi has reviewed three times and his vision has reached 0.3. Wang Xinyi said: "Thank you very much. I don't have money or jealousy. If they can't afford it, they can't cure it."

Create a literacy province and care for patients in the old district

Li Jinli, a 62-year-old patient with corneal blindness, is from Linyi, Shandong Province. He is the second patient to receive bio-engineered corneal Ai Xinyi and Fuming surgery charity donation. After Xie Lixin’s operation in October this year, he has also seen the light again.

An example of bioengineered corneal charity donation surgery, which has been landing in Shandong, has been blinded by a blind cornea living in the dark, and seeing the happy smile of the family. All of this comes from the charity event of “Bioengineering Corneal and Rehabilitation Surgery Charity Donation”.

At the end of June this year, the donation of bioengineered cornea Ai Xinyi to the elderly patients with corneal blindness in Shandong Province, China Reproductive Medicine International Co., Ltd. and employees donated bioengineered cornea Ai Xinyi and some expenses, Shandong Institute of Ophthalmology for patients free For corneal transplant surgery, Shandong Charity Federation will pay for other expenses for patients. The three units have joined forces to enable many patients with corneal blindness in the old Shandong area to receive completely free surgical treatment.

Xie Yutang, president of Shandong Charity Federation, hopes: "Strive for three years, up to five years, to build Shandong Province into the first province of corneal blind illiteracy in China." It is reported that in August and September this year, the provincial charity association will cooperate with Chinese Regenerative Medicine. Internationally, 10 to 20 artificial corneas were sent to the revolutionary old districts of Jiangxi, Guizhou, Gansu, Shaanxi and other places, so that more and more patients with corneal blind disease become the beneficiaries of free surgery and open a bright new life.

Independent research and development + industrialization, let the light reappear

The reporter learned that Ai Xinyi (decellularized corneal stroma) is the world's first and currently the only bioengineered corneal product that has gained market access. It is a major breakthrough in the field of regenerative medicine and tissue engineering in China. The product was invested by China Regenerative Medicine International Co., Ltd. and took more than ten years to develop independently.

From 2010 to 2013, the Beijing Tongren Hospital led the Sichuan University West China Hospital, Wuhan Union Hospital, Henan Eye Center and other well-known eye hospitals in China, and Ai Xinyi's clinical trials were carried out. On April 22 this year, Ai Xinyi obtained the medical device registration certificate issued by the State Food and Drug Administration. The results of clinical trials showed that the treatment of corneal ulcer with Aisin was effective, and the total effective rate reached 94.44%. The effect was closer to human donation of the cornea.

Yan Hualei, director of the Department of Corneal Diseases at Qingdao Eye Hospital, told reporters that Ai Xinyi was prepared from the cornea of ​​the pig's eye and was prepared by virus inactivation and decellularization. Its main component is collagen. It has a collagen structure of natural cornea, which removes antigens such as cells, impurities, polysaccharides, etc. in the cornea, and retains the front elastic layer and part of the matrix layer of the natural cornea. After covering the wound, it can guide the collagen synthesis and epithelial regeneration of the stromal cells, and with the migration of the self-cells, the transplanted cornea becomes transparent and the vision of the patient gradually recovers.

"Compared with human donor cornea, patients do not have to wait, no immune rejection and longer storage time." Shao Zhengkang, CEO of China Regenerative Medicine, said, "We can achieve mass production. The current production capacity is 80,000 pieces per year. Can be expanded to 300,000 pieces per year."

Source: Chinese Journal of Science

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