MFDS requests supplements for porcine islet transplant trial

Supplementary data required to start clinical trial on transplanting porcine pancreatic islet cells to humans

Central Pharmaceutical Affairs Council indicated that condition for clinical trial subjects should be clear and more safety verification data is necessary

Experts from the Ministry of Food and Drug Safety expressed the opinion that supplementary data is necessary for the clinical trial protocol studying a xenotransplantation product that transplants islet cells isolated from pigs to diabetic patients.

 

With such an opinion issued, it seems that some time would be required before the clinical trial of a xenotransplantation product is conducted.

 

The trial had gained much attention as being the ‘world’s first’ trial on a xenotransplantation product.

 

On the 30th, the Ministry of Food and Drug Safety disclosed the results of the Central Pharmaceutical Affairs Council (CPAC)’s ‘Advisory meeting on the feasibility of the submitted investigator-led clinical trial on a xenotransplantation product’ that was held on the 13th on its webpage.

 

The clinical trial aimed to transplant an islet cell extracted from a pig to a diabetes patient to verify its effect.

 

A trial testing porcine pancreatic islet cells that secrete insulin on monkeys had confirmed the long-term antidiabetic effect of such transplantation, increasing the potential for its effect in humans.

 

However, the CPAC requested data supplementation, saying that a more detailed plan is required for human trials.

 

One committee member who attended the meeting said, “Despite the efforts stated to educate patients on the self-use of Continuous Glucose Monitoring Systems and self-monitoring, the trial subjects need to be clarified to patients who were objectively verified to have low ability to recognize hypoglycemia (develop hypoglycemic coma).

 

I believe the clinical trial may be approved on the premise that the supplementations are made according to the results of the meeting.” Another member said, “Unlike animal studies, a clearer standard and evidence on selecting appropriate subjects and on the safety would be needed for human xenotransplantation studies, considering the risk and safety issues of humans who would need take immunosuppressants for the rest of their life.

 

As of now, the results are not sufficient to recommend trial commencement.” Another member emphasized, “The blood test results alone cannot ensure safety from infection in humans, especially regarding positive porcine endogenous retroviruses (PERVs).

 

Due to negative opinions on the clinical trial commencement, the Central Pharmaceutical Affairs Council collectively determined that supplementary data would be required for the protocol.

 

The CPAC delivered the opinion that the registration criteria and scope should be clarified, and sufficient quality assessment and non-clinical data (cell survival and distribution, etc) that includes evidence on the safety of porcine pancreatic islet cells (PERV, latent infection, etc.) needs to be submitted.

 

Due to this, the world’s first clinical trial using porcine pancreatic islet cells will not be approved soon.

 

In August last year, the Seoul National University’s Xenotransplantation Research Center, Gachon University Gill Medical Center, and GenNBio had submitted an application for an investigator-led clinical trial that transplants a pancreatic islet cell of a gnotobiotic pig to diabetes patients.