ICMS Investigates Patient Death

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International Society Initiates Investigation into Patient Death


PORTLAND, OREGON - Monday, October 31, 2011. The International Cellular Medicine Society (ICMS), a professional medical association dedicated to the advancement of cell-based therapies through standards, peer oversight and physician education, announced it had opened an investigation into a death of a patient who had received an autologous treatment of adipose derived stem cells at the Institute for Regenerative Medicine· (RMI) in Tijuana, Mexico.

The patient who expired was a 74 year old male from the United States. The patient was being treated in an open-label, non-randomized and multi-center study to assess the safety and effects of intra-venous implantation of stem cells in patients with pulmonary fibrosis.· The patient expired 36 days after the treatment and the cause of death has been attributed to an infection.

In accordance with ICMS Guidelines, the Society was alerted by the clinic within 48 hours of learning about the patient’s death. The clinic requested that the ICMS investigate the death and is cooperating fully. The clinic has voluntarily halted all treatments within this study until this investigation is completed. ·“The death of any patient is a serious matter,” says David Audley, Executive Director and CEO of the ICMS. “Our goal is to complete a full and independent investigation to determine the cause of this death.”

The ICMS is now in the process of compiling an investigative team of ICMS members, specialists from outside the Society and individuals from regulatory and professional oversight organizations. The ICMS anticipates an initial review of the patient’s file early this week with a preliminary report to be published after a thorough examination of the process and protocols associated with this patient’s treatment.

 

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ABOUT THE ICMS

The ICMS is a physician guided international 501(c)(3) nonprofit organization dedicated to patient safety and the protection of the practice of medicine and physician education through the production of global standards ·for the practice of cell based medicine. The society maintains two websites, www.cellmedicinesociety.org, focused on adult stem cell education and awareness for physicians and researchers and www.stemcellwatch.com, a portal for patient education and information about therapies provided at stem cells clinics around the world.

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