International Stem Cell Society Announces Conclusions and Requirements for South Korean Stem Cell Company
PORTLAND, OREGON, FEBRUARY 21, 2011 – Today, the International Cellular Medicine Society (ICMS) announced the conclusions from its investigation into the medical practices of RNLBio, and published the requirements for the South Korean company to come into compliance with ICMS Guidelines. The ICMS, a global nonprofit organization committed to advancing the field of cell based medicine through patient safety, physician education, and peer oversight, undertook this investigation after completing its adjudication of two patient deaths reported at clinics associated RNLBio in November, 2010.
The ICMS concluded its adjudication of the two deaths in December, 2010, and announced its findings at a press conference at the National Press Club in Seoul, South Korea. “In the course of the investigation,” said Dr Michael Freeman, PhD, MPH who led the adjudication for the ICMS, “The ICMS uncovered several issues about the practices of RNLBio. We felt it was essential that these issues be addressed.” Key concerns for the ICMS were the areas of informed consent and patient candidacy where RNLBio was significantly out of compliance with the ICMS’s published standards.
In response to these findings, the ICMS has developed a series of measures that will allow RNLBio to move back into compliance with the Society’s guidelines and international standards for the practice of medicine. The published report, available at the ICMS website, sets out a series of requirements for RNLBio. Among these requirements are that RNLBio immediately present itself for formal accreditation by the ICMS, the creation of an Ethics Oversight Group, the implantation of a patient management program for the collection and tracking of patient medical history and outcomes and submitting to a full audit by the ICMS within 90 days of the publication of these findings. “Our goal is to provide RNLBio with a pathway back to compliance,” said David Audley, executive director of the ICMS. “These conclusions require a significant alternation of RNLBio’s medical and business practices,” continued Audley, “But by putting patient safety first and embracing transparency and oversight, RNL has an opportunity to become an international leader in cell based medicine.”
The full findings from the ICMS investigation, including these conclusions, the adjudication report, and outcomes from the ethical review, are available at the ICMS website.
International Society Creates Global Program to Evaluate Stem Cell Clinics
Nonprofit builds accreditation process to facilitate the advancement of cell based medicine and ensure patient safety.
PORTLAND, OR, February 4, 2011 – In response to the unprecedented proliferation of non US-based stem cell clinics and the continued growth of patients traveling abroad to seek innovative cell based therapies, the International Cellular Medicine Society (ICMS) announced today a new Stem Cell Clinic Accreditation Program. The Society, an international medical nonprofit organization dedicated to patient safety, physician education, and peer oversight of cell based medical therapies, developed this program to bring transparency to these medical procedures.
“With over 200 clinics currently offering stem cell therapies globally, the need for accreditation and transparency has never been greater,” said David Audley, Executive Director of the ICMS. “Without basic standards and a method to evaluate clinics and treatments, patients and their physicians have no way of making an informed health care decision.” The ICMS has identified nearly a dozen clinics to participate in the program.
Participating clinics will undergo a rigorous evaluation over the course of 18 to 24 months. The accreditation consists of a detailed ten-step process that includes the review and evaluation of the clinics’ entire practice. This will include an assessment of informed consent procedures, patient candidacy guidelines, clinical and lab processes, and treatment protocols by an Institutional Review Board. Clinics are also required to participate in the ICMS Treatment Registry and have the outcomes and complications of all treated patients tracked by the ICMS. Additionally, clinics must undergo a series of extensive on-site evaluations conducted by the ICMS to review the clinics’ practices, patient data collection, and complaint adjudications, as well as a laboratory audit conducted by an independent, 3rd party vendor. Combined, this process is the most thorough and complete evaluation of cell based medical clinics in the world.
Clinics interested in participating in the program must submit an initial application that includes the conditions they are treating, an explanation of the treatment process and protocols, as well as the qualifications of the treating physicians. This application will be reviewed and approved by the ICMS Medical Board before a clinic moves forward in the process. “This is the first global accreditation process for cell based medical therapies,” Audley stated, “Patient s should be very wary of any clinic that refuses to submit to peer review, independent data evaluation, and real transparency standards.”
International Cellular Medicine Society Releases Findings on Stem Cell Patient Deaths
PORTLAND, OR, DECEMBER 13, 2010- 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 1, 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 Patint 2, 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 14th, 2010 at 10AM Korean time. A more detailed report on the adjudication of the deaths can be found on the ICMS website.
Second Annual International Congress on Regenerative and Cell Based Medicine to Examine the Latest Developments in Adult Stem Cells
Growth in techniques, research, and technology bringing cell based medicine closer to important practical applications
PORTLAND, OREGON, SEPTEMBER 30, 2010 – The International Cellular Medicine Society (ICMS), a nonprofit organization committed to patient safety, peer oversight, and physician education in the medical use of adult stem cells, announces the 2nd Annual International Congress on Regenerative and Cell Based Medicine on November 11-12, 2010 at the M Resort in Las Vegas, NV. This professional medical conference brings together experts who are driving the field of adult stem cell technologies as part of their everyday practice of medicine. The ICMS will host lectures from physicians from around the world on how adult stem cells are being used in the clinical setting to treat patients.
“This conference is a one-of-a-kind opportunity for physicians, researchers, and clinicians from a variety of countries who are providing stem cell procedures, or evaluating them as potential options, to discuss the clinical state of the art for these promising therapies.” said David Bonner, PhD, Chairman & CEO of Stematix, Inc. “This conference promises great value to the participants in that it focuses entirely on how adult stem cells are being used in the clinic.”
The event will showcase presentations made by internationally acclaimed physicians on the use of platelet rich plasma (PRP), bone marrow aspirant concentrate (BMAC), and adult stem cells derived from adipose tissue, bone marrow, and peripheral blood. Speakers will attend from nearly a dozen countries to present clinical experience and patient outcome data on indications such as Parkinson’s Disease, Critical Limb Ischemia, Angina, Diabetes, COPD, and Degenerative Disc/Joint Disease.
As a new feature to this year’s conference agenda, the ICMS will be providing a one-day hands-on workshop on Essential Knowledge in Stem Cell Collection Techniques. This exciting workshop will provide physicians with a unique opportunity to learn the basics of the safe and effective collection of cells from seasoned specialists that are pioneering this field. The course will provide professional training in the collection of PRP and mesenchymal stem cells from bone marrow, adipose and peripheral blood.
“As cell based medical techniques gain traction in the clinic,” said Dr. Vasilis Paspaliaris, founder of AdiStem, “providing independent education, by an international physician-driven nonprofit medical organization, like the ICMS, is critical.”
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The 2nd Annual International Congress on Regenerative and Cell Based Medicine and the Essential Training in Stem Cell Collection Techniques is being held in Las Vegas on November 11 and 12th in conjunction with the Clinical Applications for Age Management Medicine hosted by the Age Management Medicine Group.
International Cellular Medicine Society Builds Support for Patient Safety and Education in Asia
Executive Director Delivers Keynote Remarks in Japan Following Meeting with Korean Senate
PORTLAND, OREGON, August 4, 2010 – The International Cellular Medicine Society’s (ICMS) Executive Director, David Audley, delivered the opening remarks for the 4th Annual Symposium on Regenerative Medicine and Adult Stem Cell Research in Kyoto, Japan. The ICMS is a global nonprofit organization dedicated to patient safety and education on the medical use of adult stem cells. Audley’s remarks called for physicians worldwide to unite behind best practice standards for the medical use of stem cells.
Staying true to the mission of the ICMS, Audley’s presentation dealt with the advancement of cell-based medicine through patient safety and peer oversight. After delivering powerful opening remarks, including an inspiring call to action to all physicians present, Audley continued to explain the need for transparent and unbiased information in light of current uncertainty surrounding the safety and efficacy of stem cell treatments.
“Rogue clinics are a threat to patients and ethical physicians everywhere,” said Audley. “Without peer oversight and the transparency that is only available through the ICMS treatment registries, the ability of any physician to ethically practice cell based medicine and any well-informed patient to access these treatments is in great jeopardy.”
The presentation in Japan followed a successful series of high level meetings with members of the Korean Senate to discuss the regulatory environment and the role of governments in protecting patient safety.
“These meetings were an opportunity to present the ICMS as a global best practice standards provider,” said Francesca Vitelli, PhD and ICMS Board member, “In meeting with members of the Korean Parliament, the ICMS was able to initiate conversations about the need of governments around the world to utilize a set of physician developed standards to evaluate the practices of stem cell clinics and ensure patient safety, which is the ultimate goal of the ICMS.”
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