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Cell Medicine Society Announces Initials Findings from FDA Audit

PORTLAND, OREGON. June 19, 2012. The International Cellular Medicine Society (ICMS), a global professional medical association dedicated to patient safety through the strict evaluation of cell-based treatments and the rigorous oversight of medical facilities and clinics, announced today the conclusion and initial findings from the audit of its Institutional Review Board (IRB) by the Food and Drug Administration (FDA). The ICMS is dedicated to increasing the safety and transparency of cell-based therapeutics.  In particular, the society has focused on establishing standards and guidelines for studies that fall outside the jurisdiction of the FDA.  This includes stem cell clinics outside the U.S. and clinics within the United States performing studies that fall under the definition of the practice of medicine.

In addition to providing standards and guidelines to help physicians develop safer, more transparent treatment regimes, the ICMS maintains an IRB to assess the ethical considerations of proposed studies.  This IRB, registered by the Office for Human Research Protections (OHRP), is comprised of a variety of scientific and medical experts and interested community members who share the ICMS’ dedication of increasing the safety and transparency of cell-based treatments.

The audit was conducted by the FDA to review the policies and procedures of the IRB and the protocols reviewed by the board over the last three years. Over the last three weeks, agents from the FDA reviewed nearly 25 protocols submitted by physicians who sought ethical review of treatments provided as the practice of medicine before delivering their initial findings and suggestions. The ICMS welcomed input from the FDA, and shares the FDA’s vision to provide more transparent and safer stem cell therapies.

The primary focus of the audit was to determine the status and approval policy for the study presented by the Multiple Sclerosis Research Center of New York (MSCRNY) which proposed to utilize bone marrow derived progenitor cells as a treatment for MS. The ICMS required that the MSCRNY obtain a legal opinion that the treatment was considered practice of medicine in the State of New York prior to its review. Once this opinion was provided to the MSCRNY, the study was reviewed and provisionally approved in October 2011 and then again in February of 2012. The study was declared inactive by the ICMS IRB in May 2012 pending official notice of the recruitment of the first patients by the MSCRNY.

“We decided to review this study because we believed that it is the practice of medicine in New York, and fell outside of federal regulations.” says David Harshfield, Jr., MD, chair of the ICMS IRB. The FDA has now claimed jurisdiction over this study. “It is important to note,” continued Harshfield, “that the FDA made no negative comment about our review or approval of the MS study, only about the ‘jurisdiction’.”

The findings of the audit (which will be published on the ICMS website within the next day) were delivered to the ICMS via a 483 Inspectional Observation Form which detailed the following areas of concern:

* Use of electronic signatures: With permission, the ICMS currently applies the electronic signature of the IRB chair. The FDA has requested that the Chair undertake this activity personally.

* Additional data on membership and voting records: The FDA has requested that rosters reflect the specific roles and skills of each member of the IRB, as well of those individuals who are members of the ICMS. Additionally, the FDA has requested that the IRB expand its minutes to reflect the vote of each member individually, as well as any abstentions and reclusions due to conflicts of interest.

* Minutes and SOPs: The FDA has requested that the IRB expand its minutes to provide greater detail on the nature of the reviews and the deliberations, as well as modify its standard operating procedures (SOPs) to reflect notifications for annual reviews, expressly detail the length of approval for any study and develop a process of dealing with minutes that must be edited or revised after approval.

David Audley, the executive director of the ICMS, expressed his satisfaction with the outcome of the audit, “While we have not yet received the final report from the FDA, we are very pleased with their initial conclusions.” stated Audley. “The FDA’s comments were limited to relatively minor issues such as increasing the level of detail in meeting minutes and providing a clearer explanation of the relationship of reviewers to the ICMS. We expect to be fully compliant with the recommendations of the FDA by August 1, 2012.”

Audley continued to say that he believed this audit would strengthen the ICMS’ IRB and increase the credibility of its review.  “While we clearly disagree with the FDA on the definition of the practice of medicine, we believe it is critically important to work with both state and federal agencies to increase transparency and increase safety.  We believe that working with the FDA will provide a stronger IRB, which is a service to both the clinician and the patient.”

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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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FDA 483 - ICMS IRB

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International Cell Medicine Society Announces FDA Audit

PORTLAND, OREGON – Wednesday, June 6, 2012. The International Cellular Medicine Society (ICMS), a professional medical association dedicated to patient safety through the strict evaluation of cell-based treatments and the rigorous oversight of medical facilities and clinics today announced that its Institutional Review Board was audited by the Food and Drug Administration. The ICMS welcomed this audit as part of it continuing effort to provide transparency and oversight to the emerging field of autologous regenerative and cell-based medicine.

The ICMS IRB, licensed by US Department of Health and Human Services and registered the Office for Human Research Protections, provides initial review of new studies proposed by physicians and researchers seeking to provide new treatments as part of the practice of medicine. The IRB has reviewed nearly two dozen study applications over the last 3 years from nearly a half dozen countries.

“We welcome the visit of the FDA.” says Ricardo Rodriguez, MD, president of the ICMS Board of Directors. “As a professional medical association, we share the FDA’s vision of enabling safe, effective cell-based therapies.”

David Audley, executive director of the ICMS, echoed Dr. Rodriquez’ comments, stating, “The ICMS is establishing guidelines and accreditation for cell-based medical treatments that fall outside the FDA’s mandate, and would otherwise go un-regulated.  While we understand the FDA is seeking to narrow the definition of the practice of medicine, we believe that we are fundamentally aligned in our joint efforts to give patients safe and effective options, and we look forward to their input and recommendations.”

Audley went on to express concerns over the FDA’s recent activities with regard to point of care treatments, stating, “While we do not dispute their regulatory role, we are concerned that FDA is trying to exert an influence over the practice of medicine by establishing authority over what studies an IRB can approve.  We welcome the opportunity to work hand in hand with the FDA. We also believe that it is critically important not to confuse autologous therapies that are delivered at the point of care (like in vitro fertilization) with allogeneic therapies that are meant to treat thousands of patients from a single lot.”

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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.

The ICMS has published the April edition of its online magazine, Currents in Cell Medicine.

Currents in Cell Medicine is a monthly magazine dedicated to publishing the latest in news and research pertaining to stem cells and regenerative medicine.

The full edition for April, 2012 is available HERE.

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International Cell Medicine Society Responds to Editorial by Dr von Eschenbach

PORTLAND, OREGON – Tuesday, February 28, 2012. The Executive Board of 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 read with keen interest the editorial written by the former commissioner of the Food and Drug Administration (FDA) regarding the regulatory conundrum facing Regenerative Medicine in the US, particularly when using a patient’s own cells.

The ICMS and its 3500 members from over 30 countries agree with Dr von Eschenbach that the field is on the brink of great opportunity.  There is no argument that regenerative medicine will change healthcare.  Rather, the argument is how to best advance this emerging field. Thus far, two pathways for safe clinical translation have been defined: physician innovation and the FDA. Many have observed that while the FDA process for regulating new cell-based medicines is imperfect, it is preferable to the alternative. It has been argued that without FDA regulation the result would be the proliferation of unregulated ‘rogue’ clinics that prey on the hope of desperate patient-victims.

This is a false dichotomy.  Far from halting the proliferation of clinics, this activity has driven more patients overseas to seek treatment alternatives. By stymieing innovation and patient access in the US, where clinics can be monitored by licensing boards and held accountable for their actions, we have created an environment that drives desperately ill patients abroad. Instead of delivering on their mission of patient safety, the regulatory actions of the US government have nurtured a vibrant medical tourism industry. While many overseas clinics offer therapies based upon good patient care and sound science, others are substandard and unaccountable.

Patients, many of whom perceive these clinics as their only alternative, have no way of knowing the good from the bad, and are forced to make a healthcare decision based upon speculation and intuition. This reality is untenable. Patient safety cannot be assured without appropriate oversight and transparency.  We therefore applaud the efforts of the Texas Medical Board and the California Institute of Regenerative Medicine (CIRM) for their programs to translate promising autologous therapies to the clinic under appropriate oversight by state medical boards. We would like to add to this foundation a need for strict clinical and laboratory practice standards, accreditation of compliant facilities, and management of a safety and outcomes monitoring registry as the most effective pathways for the delivery of safe and effective treatments to patients in need.

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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.