The World Health Organization's 2010 Global Data Report on Vision Disability shows that there are more than 8 million blind people in China. Among them, corneal disease is one of the most important blind eye diseases. Guan Guoliang, chairman of the decision-making committee of China Regenerative Medicine Group, pointed out that there are about 60 million corneal blind patients worldwide and about 4 million in China. At present, allogeneic human corneas obtained by transplant donation are the main treatment methods, but the national donation of corneas is less than 5,000 cases per year, which is far from meeting the needs.
The bioengineered corneal products independently researched and developed by the Chinese team of scientists were released in Beijing on the 23rd, which is expected to solve the clinical dilemma of the lack of human corneal donation in China, and bring light to patients with corneal blindness.
The bioengineered cornea "Ai Xinyi" was jointly developed by China Regenerative Medicine International Co., Ltd. and the Fourth Military Medical University Organizational Engineering Research and Development Center. At the end of April, it obtained the medical device registration certificate issued by the State Food and Drug Administration.
According to Guan Guoliang, chairman of the decision-making committee of China Regenerative Medicine Group, “Ai Xinyi†is the world's first and only high-tech artificial cornea product to complete clinical trials. The product is completely developed by Chinese scientists and has complete independent knowledge. Property rights, at the same time, has built an industrialized scale production base.
The World Health Organization's 2010 Global Data Report on Vision Disability shows that there are more than 8 million blind people in China. Among them, corneal disease is one of the most important blind eye diseases. Guan Guoliang pointed out that there are about 60 million corneal blind patients in the world and about 4 million in China. At present, allogeneic human corneas obtained by transplant donation are the main treatment methods, but the national donation of corneas is less than 5,000 cases per year, which is far from meeting the needs.
Professor Jin Yan, director of the Tissue Engineering Research and Development Center of the Fourth Military Medical University, pointed out that the biggest feature of “Ai Xinyi†is that it has good integration, and the product is naturally integrated with the human eye. At present, some artificial corneal products in foreign countries mainly use silica gel as the material, and the patient's rejection reaction is obvious.
"'Ai Xinçž³' is a special process of the heterogeneous cornea, which removes the cells, proteins, polysaccharides and other antigens in the cornea, retains the natural corneal matrix collagen structure, has good biocompatibility and high biosafety. Rapid integration with the surrounding tissues, and with the relocation of their own cells, the transplanted cornea gradually becomes transparent, and the patient's vision gradually recovers," said Jin Yan.
According to Jin Yan, starting from 2010, Beijing Tongren Hospital led by many famous domestic eye hospitals such as West China Hospital of Sichuan University, Wuhan Union Hospital and Henan Eye Center participated in the clinical trial of “Ai Xinyiâ€. The test results show that the total effective rate reaches 94.44%, and the effect is close to the human donation of the cornea.
On the same day, China Regeneration Medicine International Co., Ltd. and Shandong Eye Hospital jointly launched the "China Regenerative Medicine Bioengineering Corneal Transplant Surgery Training Base" officially launched. It is understood that this year, five training bases will be established in China.
Related: The Chinese team has been independently researched and developed for 10 years.
Comprehensive CCTV, China News Service, China's first self-developed world's first bioengineered cornea, officially put into production yesterday. The product is based on the cornea of ​​the pig's eye. The main component is collagen, which will change the dilemma of the source of corneal donors in China, and bring hope for the recovery of 4 million or even 60 million corneal blind patients in China.
At the end of April this year, the State Food and Drug Administration issued a medical device registration certificate for “Ai Xinyiâ€, marking a major breakthrough in the field of corneal regenerative medicine. Since 2010, Beijing Tongren Hospital has taken the lead, and many well-known eye hospitals such as West China Hospital of Sichuan University, Wuhan Union Hospital and Henan Eye Center have participated in the clinical trial of “Ai Xinyiâ€. The test results show that the total effective rate reaches 94.44%, and the effect is close to the human donation of the cornea. According to Zhang Mingchang, director of ophthalmology at Wuhan Union Hospital, 47 patients who participated in the clinical trial of bioengineered corneal transplantation in Wuhan Union Hospital achieved all the desired therapeutic effects. Postoperative follow-up examination showed that the bioengineered cornea was clear and transparent, and it was highly fused with the original normal corneal structure, which was safe and effective.
According to Prof. Zhang Mingchang, director of the Department of Ophthalmology, Wuhan Union Hospital, the No. 1 patient who participated in the clinical trial suffered from fungal keratitis in 2010, and 2/3 of the right eye was covered by ulcer lesions, almost blind. At the end of September 2013, the results of the 1st patient review showed that the right eye vision of the transplanted “Aixin†was restored to 0.4, while the normal left eye had a visual acuity of 0.5, and there was no difference between the eyes.
Professor Zou Liuhe, a well-known domestic ophthalmologist and director of the original keratology department of Beijing Tongren Hospital, believes that the biggest feature of “Ai Xinyi†is that it has good integration, and the product is naturally integrated with the human eye. At present, some artificial corneal products in foreign countries mainly use silica gel as the material, and the patient's rejection reaction is obvious.
It is reported that the bioengineered cornea "Ai Xinyi" is a team of scientists of China Regenerative Medicine International Co., Ltd., which has been independently researched and developed for 10 years. The Chinese Regenerative Medicine Group has established scientific research cooperation with Oxford University and the University of Hong Kong.
related information
Donation of cornea is in short supply
Keratopathy is the second most common blind eye disease after cataracts and is increasing at an annual rate of 1.5 to 2 million cases. There are currently about 60 million corneal blind patients in the world, of which about 4 million are in China. In China, 100,000 patients with corneal blindness are added each year, but the national donation of corneas does not exceed 5,000 per year.
At present, the treatment of corneal blindness mainly includes human donor corneal surgery transplantation and artificial corneal transplantation. Although foreign countries have developed artificial corneas made of heterogeneous materials such as glass and silica gel, the patient's rejection reaction is obvious.
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