Questions continue over RNLs stem cell handling

By Kim Tong-hyung

Biotechnology companies in Korea have been shrugging off concerns that the premature use of stem cell therapy could put many patients at risk. However, the situation has obviously become serious now, as health authorities are looking into reports of patient deaths and cancer development.

At the center of the controversy is RNL Bio, a Seoul-based firm known for its expertise in stem cell research and commercial animal cloning, which is now suspected of profiting from “stem cell tourism,” or connecting patients to foreign clinics providing stem cell injections, plus even unlawfully providing treatments of its own.

RNL has been linked with the deaths of two patients who died after receiving stem cell injections at clinics in China and Japan, while another patient claims he has been diagnosed with cancer developing in his neck after receiving injections at a different Chinese clinic.

RNL has been extracting patient-specific stem cells from the adult cells of its customers, who then take the samples to clinics in China and Japan for treatment, as Korea has yet to allow stem cells to be used in clinical practices.

The business practices of the company currently is under review by the Ministry of Health and Welfare and the Korea Food and Drug Administration, while prosecutors are debating whether there are legal grounds for punishing hospitals exporting patients overseas for stem cell treatments.

There is a possibility that the murky allegations surrounding RNL could explode into a national scandal, as the company is suspected of providing free stem cell treatments to politicians, bureaucrats and celebrities in return for lobbying for eased regulations on stem cell trials.

“We need to take a harder look at the issue, but it’s not that China and Japan are controlling stem cell treatments loosely. Both countries are restricting private practices as strictly as we do and closely controlling clinical trials,” said a Health Ministry official.

“Obviously, there could be legal consequences if RNL is found to have been playing the role of an agency.”

In a recent news conference, Ra Jeong-chan, the scientist-turned-chief executive officer (CEO) of RNL, claimed that there was no solid evidence to suggest that the deaths were related to stem cells the company derived from them.

He also insisted that the company has merely been introducing the Chinese and Japanese clinics that provide stem cell treatments to willing patients and denied the existence of a business connection with these hospitals.

However, it appears that Ra was being liberal with the truth as RNL has said it had gathered around 4,900 customers for its “medical tours” through the first half of this year in a report to financial regulators in August. This was after the company claimed that its “expanding” medical tour operations will be key to the growth of its adult stem-cell business division in another regulatory filing last year.

Interestingly, medical tours are not mentioned at all in RNL’s third-quarter report that was filed to the Financial Supervisory Service (FSS) on Monday.

Investigators are also looking into the suspicions that RNL has been providing stem cell injections of its own. At the news conference, Ra said RNL has introduced around 8,000 of its patients to foreign clinics for stem cell injections, about 3,000 more than what the company reported in its August regulatory filing.

Even when considering RNL’s array of trials in progress, which includes research for spinal cord injuries and Buerger’s disease, 3,000 is still a significant gap to explain.

“Eight thousand would be an accurate number, and none of them were treated in Korea. Considering that the treatments were conducted in clinics overseas, some of the names may overlap or were omitted,” said an RNL official.

Regardless of whether RNL has done anything illegal or not, it would be hard for the company to avoid criticism that it had encouraged desperate patients to spend massively on unproven, risky treatments that are not yet allowed under Korean law.

Stem cells are known for their versatility to grow into assorted tissue types, and scientists believe they will eventually grow to replace cells and organs that have been damaged by disease or injury.

It is known that there are about 100 private clinics in the world that offer stem cell treatments for a wide range of conditions such as Parkinson’s disease, diabetes and spinal injuries.

However, critics urge health authorities to establish stronger oversight systems to prevent patients from becoming vulnerable to risky treatments that are being put into clinical practice without proper safety analysis.

“RNL strongly pushed our family to have our father take the stem cell injections at the Chinese clinic to treat his diabetic symptoms. After coming back from China, he died just two months later during surgery for a cardiovascular problem. He died of breathing problems after the procedure,” said Jeon, the son of one of the stem cell patient victims.