ICMS Announces Investigation Findings

The International Cellular Medicine Society (ICMS) today announced the findings of its investigation into the cause of the deaths of two patients of RNL Bio, a Korean company engaged in the medical removal, banking and provision of stem cells for use in patients. The patients had both received intravenous infusions of stem cells that had been derived from their own fat tissue.

The investigation of the deaths was led by ICMS Board President Dr. Michael Freeman, forensic epidemiologist and Affiliate Professor of Epidemiology at Oregon Health & Science University School of Medicine and Adjunct Associate Professor of Forensic Medicine at Aarhus University. The investigation involved extensive interviews and review of documents, as well as consultation with experts in clinical applications of stem cells, including Dr. Keith March, Professor of Medicine and Director of the Vascular and Cardiac Center for Adult Stem Cell Therapy at the Indiana University School of Medicine. As a result of findings uncovered during the investigation into the patients’ deaths, the ICMS initiated an on-site evaluation of ethical and clinical practices of RNL Bio, conducted by Dr. Glenn McGee, John B. Francis Endowed Chair of Bioethics at the Center for Practical Bioethics.

The ICMS has made the following findings:

• The death of patient JJJ, which occurred nearly 2 months after his last stem cell infusion, was unlikely to have been caused by either the stem cells or the procedures used to administer the stem cells. The specific cause of Mr. Jun’s death is currently unknown as no documentation has been released with this information.
• The death of patient LSK, which occurred on the same day as the stem cell procedure, was likely to have been caused or triggered by the stem cell procedure. The cause of death was due to a pre-existing blood clot that traveled to the lungs, and may have been precipitated by the procedure used to infuse the stem cells, or less probably, from a clot formed by the cells.
• No evidence was found to suggest that inaccurate information caused either patient to give consent to medical procedures that they otherwise would not have given. A review of all relevant forms, chart notes, correspondence, and interviews suggests that both patients were provided sufficient information to give appropriate informed consent, and both did give consent.

The International Cellular Medicine Society is the only medical society whose mission is the promotion of safety and efficacy in the clinical practice of adult autologous stem cell therapy.  The ICMS promulgates clinical guidelines for physicians for best practices for the collection, processing and re-injection of stem cells in clinical practice, and also maintains a Treatment Registry to track the outcomes of patients who have received stem cells. The ICMS actively investigates the entire range of activities associated with adult stem cell research and therapeutics with special attention to ethical issues, including the informed consent of the patients undergoing the procedures. RNL Bio is a participant in the ICMS registry, and as of December 2010 has committed to registering all patients for outcome tracking.

“We have received full support and cooperation from RNL in this investigation, and confirmation that they will make any changes necessary to come into compliance with the ICMS clinical guidelines”, stated David Audley, the executive director of the ICMS.  “RNL Bio has agreed to participate in a program to develop more comprehensive ethics training as part of the development of its practices,” added Dr. McGee.  Both Mr. Audley and Dr. McGee will discuss the results of the ICMS investigation at the National Press Club in Seoul, Korea on December 14^th, 2010 at 10AM Korean time.