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Bioengineered corneas to enter mass production in China(2)

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2015-06-11 10:12Global Times Editor: Li Yan

Patients' gospel

Huang tried opening up her eyes after the surgery and found her vision to be fuzzy.

She was not aware that she had become the first person in China to receive an artificial cornea transplant.

Her vision gradually improved and her right eye recovered to about 80 percent the level of her left eye.

She was not aware that after her, doctors were encouraged, and another 114 transplants were performed in five hospitals across China. Out of these transplants, 109 succeeded.

These patients were required to come back for re-examinations in a few months. The result was surprisingly good: the artificial corneas worked about as well as natural ones.

In April, the China Food and Drug Administration gave Aixintong a medical certificate, recognizing the product as the first cornea bioengineered and patented by Chinese scientists and granting it approval to be used.

In July, the artificial cornea will be mass-produced and used in surgery.

Right now, some patients are already inquiring about the cornea in the Wuhan Union Hospital, where Huang Yuanzhen got treated. In the past, people who couldn't wait on a donated cornea often had to have their eyeball removed because it could become infected.

In January 2015, Huang Jiefu, director of the human organ transplant clinical technology application management committee under the National Health and Family Planning Commission, announced that China's human organs will be sourced only from donors, not from executed criminals.

Facing a situation with even fewer organs to be used in transplantation, the Chinese scientists pushed to mass-produce Aixintong.

Preparations to use the artificial corneas are in place. According to media reports, the Shandong Ophthalmology Hospital has begun training surgeons to implant the artificial cornea. The program is hoping to recruit 100 doctors this year.

A doctor in Shandong Province told the China Youth Daily that in the future, patients may be able to get cornea transplants within two days of diagnosis.

In order to supply pig corneas, scientists established a pig farm in Shenzhen, Guangdong Province. All pigs in the farm have their own "ID number."

If a cornea is found to be faulty after transplant, scientists can easily track which pig it came from.

Doubts remain

Jin said many questioned his research at the beginning. When he went to academic conferences, only a small number of people thought he might succeed.

Despite his success, his innovation has not been widely adopted internationally at this time.

After Jin's team published the results, a research team in the U.S. published a paper in the scientific journal of the Association of Research in Vision and Ophthalmology, pointing out there may be imperfections in the decellularization methods currently used by international research teams. It names Jin's team in particular.

Even doctors in China had doubts when they were conducting clinical experiments with Aixintong. The invention was too new.

Zhang Mingchang from Wuhan Union Hospital said when he was performing surgery for Huang, he had his doubts. He didn't even know whether Aixintong was safe, let alone whether it would work.

When performing surgery, he had a few backup corneas, including one from a human donor, in case Aixintong failed.

But after Huang's recovery and after the re-evaluation of her eye's condition in 2013, Zhang's doubts gradually vanished.

He became even more optimistic about the prospect of Aixintong after completing 47 transplantations as a clinical trial and maintaining a success rate of over 90 percent.

Huang had no idea of the doubts and controversies involving Aixintong.

In May, she was invited by the CRMI to come to the launching ceremony of Aixintong in Beijing. Afterwards, she went to Tiananmen Square for the first time. It was unbelievable that she could see those sites with both eyes, especially when she thinks back about the days she thought she would be blind in one eye forever.

During the ceremony, she couldn't explain how the cornea worked, but she kept saying, "This works well, I can do work on the farm fields again."

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