International Stem Cell Society Announces Conclusions and Requirements for South Korean Stem Cell Company

PORTLAND, OREGON, FEBRUARY 21, 2011 – Today, the International Cellular Medicine Society (ICMS) announced the conclusions from its investigation into the medical practices of RNLBio, and published the requirements for the South Korean company to come into compliance with ICMS Guidelines. The ICMS, a global nonprofit organization committed to advancing the field of cell based medicine through patient safety, physician education, and peer oversight, undertook this investigation after completing its adjudication of two patient deaths reported at clinics associated RNLBio in November, 2010.

The ICMS concluded its adjudication of the two deaths in December, 2010, and announced its findings at a press conference at the National Press Club in Seoul, South Korea. “In the course of the investigation,” said Dr Michael Freeman, PhD, MPH who led the adjudication for the ICMS, “The ICMS uncovered several issues about the practices of RNLBio. We felt it was essential that these issues be addressed.” Key concerns for the ICMS were the areas of informed consent and patient candidacy where RNLBio was significantly out of compliance with the ICMS’s published standards.

In response to these findings, the ICMS has developed a series of measures that will allow RNLBio to move back into compliance with the Society’s guidelines and international standards for the practice of medicine. The published report, available at the ICMS website, sets out a series of requirements for RNLBio. Among these requirements are  that RNLBio immediately present itself for formal accreditation by the ICMS, the creation of an Ethics Oversight Group, the implantation of a patient management program for the collection and tracking of patient medical history and outcomes and submitting to a full audit by the ICMS within 90 days of the publication of these findings. “Our goal is to provide RNLBio with a pathway back to compliance,” said David Audley, executive director of the ICMS. “These conclusions require a significant alternation of RNLBio’s medical and business practices,” continued Audley, “But by putting patient safety first and embracing transparency and oversight, RNL has an opportunity to become an international leader in cell based medicine.”

The full findings from the ICMS investigation, including these conclusions, the adjudication report, and outcomes from the ethical review, are available at the ICMS website.