Concerns are rising that Korea may lose its lead in xenotransplantation technology due to the government's neglect and indifference.
The Xenotransplantation Research Center said on Oct. 17 that it has drawn up a clinical trial plan for transplantation of pig organs into humans but cannot push ahead with it due to the absence of legal basis in Korea.
The center’s researchers held a news conference at Seoul National University's medical school to explain the problems it faces in pursuing commercialization of its xenotransplantation technology.
Xenotransplantation research focuses on the transplantation of tissues of organs from designated pathogen free (DPF) pigs to humans. The need to develop xenotransplantation technology is growing as the number of patients who need organ transplantation has been increasing, while the supply of organs is limited.
The research center said international experts have endorsed its clinical trial plan to transplant the pancreas and cornea of pigs to humans. Experts from various fields of transplantation, including the International Xenotransplantation Association (IXA) and the Ethics Committee of the Transplantation Society (TTS), participated in the deliberation of the plan.
In particular, the pig pancreatic transplant, which has been studied by the Korean research center, is the fundamental treatment of type 1 diabetes, which usually develops in children. As such, it has been drawing keen attention from scholars and patients. Type 1 diabetes requires pancreatic transplants because insulin is not released in the pancreas of the patients by birth. However, it is impossible to transplant the pancreas between people since it is usually necessary to separate the pancreas from 2 to 4 brain dead people.
The research center succeeded in maintaining blood sugar by transplanting pig pancreas into diabetic monkeys in 2015, but they face hurdles in conducting clinical trials due to the absence of regulations on such trials.
The World Health Organization (WHO) offers guidelines on the practice of xenotransplantation clinical trials, which recommends researchers to comply with the relevant laws in their own countries. But the Korean government has neither created regulations on xenotransplantation nor designated an agency to handle the related matters.
It is also pointed out that the legal basis and accountability for continuous monitoring of people who need xenotransplantation are also unclear. Due to the nature of the xenotransplantation, unknown infections can occur. The research center believes that it is difficult to conduct a clinical trial if its researchers have to bear all responsibilities for patient safety due to the absence of the relevant regulations.
For this reason, the research center is considering requesting the relevant government agencies to deliberate on whether the law on prevention and management of infectious diseases can include people who undergo xenotransplantation.
"The expert review has cleared the way for us to conduct clinical trials on patients in January next year, but we will not be able to carry out the tests because the patients and the public are not guaranteed of safety," said Park Jeong-kyu, head of the research center.
Concerns are expressed that the world's best technology for xenotransplantation could die out due to the government’s neglect. The U.S. and other countries have already prepared regulations and legal grounds for xenotransplantation. In the U.S., the Food and Drug Administration (FDA) oversees all work on xenotransplantation.
"If the Korean research center had applied for this trial in the U.S., it would have received the green light from the FDA," said Richard N. Pearson, a Harvard University professor who is a former IXA head and currently a member of TTS Ethics Committee.
"The results of research and development that our research center has achieved in the field of xenotransplantation are already the highest in the world," Park said. “If we fail to start clinical trials before the research period of our center expires, we will lose human resources and knowhow, which will be a great loss to Korea,
The center’s research period expires May next year.