FOR IMMEDIATE RELEASE
Contact: David Audley
www.cellmedicinesociety.org
International Society Reports Findings from Investigation into Patient Death
PORTLAND, OREGON - Monday, November 14, 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 its findings from an investigation into the 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 clinic, a participant in the ICMS Accreditation Program, requested that the ICMS investigate the death, and fully cooperated with the ICMS. The cause of death has been attributed to an infection.
Upon the request of the clinic, the ICMS convened a commission of three physicians to review the treatment. ICMS reviewed the patient files and interviewed key executives of the clinic. According to records obtained by the ICMS, the patient was told by his family physician that he was very weak and that another infection would most likely be fatal. The patient sought the care in Mexico, and was informed of all the risks and signed an informed consent prior to the treatment.
In accordance with the treatment protocols and ICMS standards, the patient was followed up with by the clinic post therapy. Follow ups were performed by clinic staff at 1 week and 3 weeks after the treatment. At each interval, the patient did not report any infection or illness. The infection appears to have set in between the 2nd and 3rd follow up which was initiated at 4 weeks post-treatment. It was during this follow up that the family informed the clinic that the patient has passed away.
Citing religious considerations, the family did not authorize an autopsy and there is no coroner’s report to establish the cause of death as anything other than infection.
Upon review, the ICMS has determined that the infection was not likely caused by either the injection or a direct result of the therapy. As such, the ICMS will not initiate any further instigation into this death. Given the circumstances of the death, the proximity of the treatment to the death and the lack of autopsy report, the ICMS makes the following recommendations:
1. That the ICMS will continue to closely monitor the outcomes of all of RMI's patients to look for any other potential severe adverse events (SAEs) or complications,
2. That the ICMS conduct an audit of the clinic to review outcome collection protocols and patient data with clinic staff, and
3. That RMI present to the ICMS IRB patient outcomes data for review and evaluation three (3) months from this date.
As a patient safety organization and professional medical association, the ICMS takes any report of a patient death seriously. We are pleased that RMI fully cooperated with this investigation and engaged the ICMS at the earliest possible date. The ICMS implores all other clinics to embrace transparency and peer oversight in order to advance this field and protect patient health and safety.
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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.
Contact: David Audley
www.cellmedicinesociety.org
International Society Reports Findings from Investigation into Patient Death
PORTLAND, OREGON - Monday, November 14, 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 its findings from an investigation into the 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 clinic, a participant in the ICMS Accreditation Program, requested that the ICMS investigate the death, and fully cooperated with the ICMS. The cause of death has been attributed to an infection.
Upon the request of the clinic, the ICMS convened a commission of three physicians to review the treatment. ICMS reviewed the patient files and interviewed key executives of the clinic. According to records obtained by the ICMS, the patient was told by his family physician that he was very weak and that another infection would most likely be fatal. The patient sought the care in Mexico, and was informed of all the risks and signed an informed consent prior to the treatment.
In accordance with the treatment protocols and ICMS standards, the patient was followed up with by the clinic post therapy. Follow ups were performed by clinic staff at 1 week and 3 weeks after the treatment. At each interval, the patient did not report any infection or illness. The infection appears to have set in between the 2nd and 3rd follow up which was initiated at 4 weeks post-treatment. It was during this follow up that the family informed the clinic that the patient has passed away.
Citing religious considerations, the family did not authorize an autopsy and there is no coroner’s report to establish the cause of death as anything other than infection.
Upon review, the ICMS has determined that the infection was not likely caused by either the injection or a direct result of the therapy. As such, the ICMS will not initiate any further instigation into this death. Given the circumstances of the death, the proximity of the treatment to the death and the lack of autopsy report, the ICMS makes the following recommendations:
1. That the ICMS will continue to closely monitor the outcomes of all of RMI's patients to look for any other potential severe adverse events (SAEs) or complications,
2. That the ICMS conduct an audit of the clinic to review outcome collection protocols and patient data with clinic staff, and
3. That RMI present to the ICMS IRB patient outcomes data for review and evaluation three (3) months from this date.
As a patient safety organization and professional medical association, the ICMS takes any report of a patient death seriously. We are pleased that RMI fully cooperated with this investigation and engaged the ICMS at the earliest possible date. The ICMS implores all other clinics to embrace transparency and peer oversight in order to advance this field and protect patient health and safety.
###
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.