Controversial Korean Stem Cell Powerhouse in Big Trouble?

Posted by Pete Shanks July 22, 2013
Biopolitical Times

RNL Bio is a Korean biotechnology conglomerate notorious for pushing the ethical, commercial and allegedly legal envelopes in pursuit of what seems to be the goal of becoming a multinational force in biotechnology. It has demonstrated a remarkable ability to combine real scientific expertise with a talent for headline-grabbing. They've done dog cloning (with an explicit goal of performing chimeric human research), sold stem-cell cosmetics, and established subsidiaries or partnered with companies in California, Texas, Germany, China and Japan.

Now RNL Bio is undergoing some major changes. How much difference they will make in the long run remains to be seen, but certainly the enterprise has suffered some significant setbacks:

  • The parent company was delisted from the Korean stock exchange in April.
  • RNL Europe went bust earlier this year and has been sold (according to the updated resume of former American Journal of Bioethics editor Glenn McGee, himself associated with a string of controversies).
  • In June, CEO Dr. Jeong Chan Ra (who last year pledged to donate 90% of his fortune to charity over the next decade) was arrested and charged with insider trading and also accused of sexual harassment.

The company has had legal issues for some time, not least because of its apparent attempts to circumvent Korean law by treating patients in Japan and China, perhaps with smuggled stem cells. In the U.S., RNL Bio used to be partnered with Celltex, the Texas company that became notorious for treating former and perhaps future Presidential candidate and Texas governor, Rick Perry. Then it set up a U.S. subsidiary, Human Biostar; Celltex is suing them both, and facing a countersuit. Meanwhile, Human Biostar is being sued in Los Angeles for fraud.

As recently as May, the Korean company filed an Investigational New Drug application with the FDA to begin clinical trials of an adult stem cell product for the treatment of osteoarthritis. At around the same time, RNL Bio and Human Biostar announced that they were offering direct-to-consumer adult stem cell banking in the U.S. — not treatments (that would be wrong) but storage for physicians whose patients request the service.

Confused yet? Fortunately, Leigh Turner and Paul Knoepfler have done remarkable work keeping up with all this. Turner's Health in the Global Village effectively broke the arrest story in English (with thanks to Dersu na Amure). Knoepfler's Stem Cell Blog is running a series on Celltex documents he obtained from the FDA via an FIOA request; apparently the most revealing letter is yet to come.

Contrary to some speculation, RNL Bio claims not to be going away. The company has appointed a new CEO, Hyoung Seung Lee, with strong connections to the old regime, who is reportedly planning to divest some divisions and focus on the stem cell business.

Previously on Biopolitical Times: