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International Cell Medicine Society Publishes National Guidelines for Medical Use of Stem Cells in Mexico
PORTLAND, OREGON – Friday, March 2, 2012. The International Cellular Medicine Society (ICMS), a professional medical association dedicated to patient safety through the strict evaluation of cell-based therapies and the rigorous oversight of medical facilities and clinics has published an overview of the regulations for the medical use of stem cells in the United States of Mexico.
In Mexico, as in much of the rest of the world, the topic of progenitor cells or stem cells is still under review. Recent congressional actions in Mexico have introduced the issue of stem cells into our national health laws. Although it has been given full recommendation by the Senate Health Committee, it is scheduled for a full vote early March, 2012.
From those Health Committee recommendations we get the following:
The use of embryonic progenitor cells is strictly forbidden for therapeutic, educational or research use, regardless of its origin.
In the case of the therapeutic use of hematopoietic progenitor cells derived from placental blood or bone marrow, use will be limited to hematological (blood) diseases.
All cases of use of hematopoietic progenitor cells derived from placental blood or bone marrow, other than therapeutic or educational, shall be considered for research purposes.
Those cases considered for research purposes must be subjected to the established rules set by the General Health Code as it pertains to health research, under the sanitary supervision of COFEPRIS in coordination with the National Center for Blood Transfusion (CNTS).
Sections 41 Bis, 98, and 315 of the General Health Code stipulates that all establishments must possess the following authorizations and/or permits:
Sanitary license and responsible physician.
Organ, tissue and cell bank license.
Bioethics, Biosafety and Research committees.
Transplant committee.
In the case of research use, the head researcher must submit the research protocol to consideration by hospital committees, in accordance with the General Health Code as it pertains to the matter of health research.
The internment or export of organs, tissues, blood, its components or derivatives to and from the national territory without the express permission of the National Health Authority, through COFEPRIS, is strictly forbidden.
In the cases where allogeneic placental blood-derived progenitor cells are used, they must only be requested from the Cord Blood Bank of the CNTS.
The use of any manner or form of progenitor or stem cells of animal origin is strictly forbidden.
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ABOUT THE ICMS
The ICMS is a 501(c)(3) nonprofit professional medical organization that is focused on the development of standards for the evaluation of point-of-care, cell-based therapeutics worldwide. With over 3,500 members from over 35 countries, the ICMS is a global leader in patient safety through strict evaluation of therapies and rigorous oversight of clinics and facilities providing cell-based medical therapies. The ICMS maintains an independent Institutional review Board and manages a comprehensive Treatment Registry that tracks patient outcomes. More information can be found at www.cellmedicinesociety.org,
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International Cell Medicine Society Elects New President
PORTLAND, OREGON – Tuesday, February 28, 2012. The International Cellular Medicine Society (ICMS), a professional medical association dedicated to patient safety through the strict evaluation of cell-based therapies and the rigorous oversight of medical facilities and clinics announces that Dr Ricardo Rodriguez, MD has been elected President of the ICMS Board of Directors.
“We are pleased to welcome Dr Rodriquez as President,” says David Audley, executive director of the ICMS. “He has served on the board of directors for two years. He is committed to the mission of the ICMS and his experience as a physician will be valuable as the ICMS continues to grow as a professional medical association.”
Dr Rodriguez is will assume the role of president from Dr Michael Freeman, PhD, MPH, who has served as the head of the ICMS since 2009. “Dr Freeman’s leadership has been instrumental in the growth of the ICMS.” continued Audley. “He has guided us from our earliest days of a handful of physicians to our current position as the global leader in standards and accreditation for cell-based medicine.” Dr Rodriguez’s two year term will commence on March 1, 2012.
Dr. Rodriguez was trained in Plastic Surgery at Yale University Medical School. After completing his Plastic Surgery Residency, he was invited to become a Professor of Plastic Surgery at Yale Medical School, where he taught residents reconstructive and cosmetic surgery procedures. Dr. Rodriguez is Board Certified by the American Board of Plastic Surgery. In continuing with his academic dedication, Dr. Rodriguez currently serves as a clinical instructor in the Johns Hopkins Plastic Surgery Department, teaching residents of the Plastic Surgery Clinic. Dr. Rodriguez served as President of the Maryland State Society of Plastic Surgeons. He is a member of the American Society of Plastic Surgeons (ASPS). In 2004, he was honored by the ASPS with the "Distinguished Service Award" for his outstanding commitment to plastic surgery education.
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ABOUT THE ICMS
The ICMS is a 501(c)(3) nonprofit professional medical organization that is focused on the development of standards for the evaluation of point-of-care, cell-based therapeutics worldwide. With over 3,500 members from over 35 countries, the ICMS is a global leader in patient safety through strict evaluation of therapies and rigorous oversight of clinics and facilities providing cell-based medical therapies. The ICMS maintains an independent Institutional review Board and manages a comprehensive Treatment Registry that tracks patient outcomes. More information can be found at www.cellmedicinesociety.org,
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503.887.1045
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www.cellmedicinesociety.org
International Cell Medicine Society Supports Texas Medical Board
PORTLAND, OREGON – Monday, February 27, 2012. The International Cellular Medicine Society (ICMS), a professional medical association dedicated to patient safety through the strict evaluation of cell-based therapies and the rigorous oversight of medical facilities and clinics expresses its support for the recent actions of the Texas Medical Board (TMB). The decision of the TMB to give preliminary approval to a set of rules for adult stem cell therapies in Texas, including Institutional Review Board (IRB) approval and patient informed consent, is a strong first step in balancing physician innovation and patient safety.
The ICMS has spent the last three years providing global leadership in patient safety and adult cell-based medicine. Through its maintenance of an independent IRB, the publication of the only comprehensive set of guidelines for the practice of cell-based medicine and a global accreditation program for medical clinics and facilities, the ICMS has been an advocate for the oversight proposed by the TMB. “We applaud the ruling, says David Audley, executive director of the ICMS. “As a professional medical association the ICMS has been in the forefront of protecting patients. The ruling of the TMB is a validation of both the promise of these therapies as well as the need for strong, peer guided oversight.”
The ruling of the TMB is aligned with the basic tenets of the ICMS. The Society has developed a set of guidelines that mandate informed consent for patients, IRB approval for treatments, provide rules for patient recruitment, complication reporting and outcome tracking. These guidelines, while considerably more strict than the ruling of the TMB, are the basis for the global accreditation program that has become the mission of the Society. As part of this process, the ICMS has actively evaluated the practices of clinics worldwide and removed clinics and providers from the Society for failure to maintain compliance to its global standards.
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ABOUT THE ICMS
The ICMS is a 501(c)(3) nonprofit professional medical organization that is focused on the development of standards for the evaluation of point-of-care, cell-based therapeutics worldwide. With over 3,500 members from over 35 countries, the ICMS is a global leader in patient safety through strict evaluation of therapies and rigorous oversight of clinics and facilities providing cell-based medical therapies. The ICMS maintains an independent Institutional review Board and manages a comprehensive Treatment Registry that tracks patient outcomes. More information can be found at www.cellmedicinesociety.org,
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503.887.1045
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www.cellmedicinesociety.org
International Cell Medicine Society Accredits Regenerative Medicine Institute
PORTLAND, OREGON – Friday, February 24, 2012. The International Cellular Medicine Society (ICMS), a professional medical association dedicated to patient safety through the strict evaluation of cell-based therapies and the rigorous oversight of medical facilities and clinics has granted the status of “Accredited” to the Regenerative Medicine Institute (RMI) of Tijuana, Mexico.
“We are pleased that RMI undertook this process,” says David Audley, executive director of the ICMS. “The clinic understood that patient safety can only be assured through strict evaluation and rigorous oversight. From day one they have embraced the transparency that this program requires.”
RMI is the first clinic to achieve this status under the ICMS Accreditation Program. The clinic has undergone two separate site audits and undergone an institutional review board review evaluation. Most importantly, the clinic has placed in excess of 50 patients into the Treatment Registry for long-term outcome tracking. “The safety profile has been excellent,” continued Audley. “We have tracked patients over at least two follow ups and a minimum of six months and not seen a single cell-related adverse event.”
The ICMS is currently evaluating nearly a dozen clinics worldwide. Accreditation is based upon the Guidelines for the Practice of Cell-Based Medicine developed and published by the ICMS. Key components of these guidelines are the ethical recruitment of patients, the proper consenting of patients and compliance with local laws and regulations in the treatment of patients.
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ABOUT THE ICMS
The ICMS is a 501(c)(3) nonprofit professional medical organization that is focused on the development of standards for the evaluation of point-of-care, cell-based therapeutics worldwide. With over 3,500 members from over 35 countries, the ICMS is a global leader in patient safety through strict evaluation of therapies and rigorous oversight of clinics and facilities providing cell-based medical therapies. The ICMS maintains an independent Institutional review Board and manages a comprehensive Treatment Registry that tracks patient outcomes. More information can be found at www.cellmedicinesociety.org,
DISCLAIMER: Cell-based medical therapies are an investigational treatment. All medical treatments carry risk. Patients are urged to consult with their physicians to weigh the risks prior to undergoing any investigational treatment. Accreditation by the ICMS should not be taken as a recommendation to seek treatment or substitute advice provided by a licensed and qualified physician.
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International Cell Medicine Society to Provide Line of Malpractice Insurance
PORTLAND, OREGON - Wednesday, December 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 an agreement with Medical Protective (Med Pro) to provide a line of professional liability coverage for ICMS members providing cell-based therapies.
“This is the first line of malpractice coverage to be offered to stem cell physicians,” says David Audley, Executive Director and CEO of the ICMS. “It is an important benefit for ICMS members, and a critical step in advancing the credibility of the field and availability of the treatments.”
While the specific coverage details of the program are not yet finalized, the malpractice insurance will be made available to qualified ICMS members in 2012. The program reflects the Society’s commitment to patient safety and is based upon the standards for clinical practice, patient safety and data collection of the ICMS. To qualify physicians will have to:
1. Be members of the International Cellular Medicine Society,
2. Participate in the clinic accreditation program of the ICMS, and
3. Place patients into a 3rd party Treatment Registry to have their outcomes tracked.
The professional liability insurance will be available only for adult, autologous (patient donated) platelet rich plasma (PRP) and other same day cell therapies. The prevalence of these therapies has increased tremendously over the last 2 years as more and more patients seek out these innovative treatments for orthopedic and cosmetic conditions. “By working with Med Pro,” continues Audley, “The ICMS will be able to provide top quality coverage to qualified physicians. This is a win for physicians, for patients and the emerging field of cell-based therapies.”
Physicians who are interested in the malpractice insurance should
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for an application for membership and an overview of the accreditation program.
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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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