 biotechnology firm RNL |
Fresh concerns are being raised about the unauthorized stem cell treatments offered by private and international clinics following reports of patient deaths and cancer development.
RNL Bio, the Seoul-based biotechnology firm that has found itself at the center of the controversy, claims that there is no solid evidence to suggest that the recent deaths of two Korean patients were related to stem cells it derived from the adult cells of the patients.
Beside the deaths, another patient claims he found cancer developing in his neck just weeks after receiving stem cell injections at a clinic in China in August last year to treat diabetes.
The incidents were revealed by Democratic Party lawmaker Joo Seung-yong in a National Assembly audit of the Ministry of Health and Welfare.
RNL had allowed the patients to take their patient-specific stem cells to hospitals in China and Japan for treatment, as Korea has yet to allow the clinical use of such stem cells.
So regardless of the debate about the safety of stem cell therapies, it would be hard for the company to escape criticism that it had encouraged desperate patients to spend massively on unproven, risky treatments that aren’t allowed under Korean law.
There are also suspicions that RNL had been profiting from ``stem cell tourism,’’ by connecting patients to foreign clinics that provide stem cell treatments, but Ra Jeong-chan, the company’s chief executive, Tuesday denied such claims.
``There has been no scientific evidence reported here or elsewhere that stem cell injections can be the cause of cancer or cardiovascular disease. In fact our studies with the Seoul National University (SNU) suggest that stem cell injections rather help suppress such conditions,’’ Ra said at a Seoul news conference, which had a circus atmosphere as RNL employees tussled with a group of five or six people, claiming themselves to be victims of faulty stem cell treatments, who attempted to enter the conference room.
Ra added to the drama by bringing up one of his clients, who didn’t reveal his name but spoke emotionally about how the stem cell treatment he received in China saved him from having to have his foot amputated, which was severely damaged due to a diabetes-related infection.
``The 73-year-old patient who died in Japan was a former surgeon, who had been in a state of fatigue, probably due to the flight, and failed to inform Japanese doctors that he previously had heart surgery before the stem cell injections. The patient who received stem cell treatments in China didn’t die there, but in a Korean hospital after failing to wake up from anesthesia, so it’s hard to see the cases being related,’’ Ra said.
According to Ra, RNL has so far introduced around 8,000 of its patients to foreign clinics that provide stem cell treatments. The company is currently conducting a trial of treatment methods for difficult conditions, such as spinal cord injuries and Buerger disease, but has yet to gain approval from the Korea Food and Drug Administration (KFDA).
Ra claims that RNL has no particular business connections with the clinics in Japan and China it has been directing its clients to.
Government officials admit that treating patients with stem cells cultured from their own adult cells, such as fat cells, would be a crime equivalent to selling unlicensed medicine. However, it’s hard to punish RNL when the clinical practices were actually conducted overseas, they said.
Stem cells are known for their versatility to grow into various tissue types, and scientists believe they will eventually 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, such as Joo, are asking health authorities to take a harder look at whether patients are becoming vulnerable to expensive and risky treatments that are being moved into clinical practice without proper safety analysis.
``Whether stem cell injections cause cancer or heart disease is not the point. The point is that companies like RNL look to be profiting from connecting patients to hospitals overseas to receive treatments that are banned under our laws,’’ said one of the lawmaker’s assistants.
