JUNE 6, 2011. PORTLAND, OR/TIJUANA, MEXICO

The total number of clinics offering stem cell medicine in Mexico is not currently known, though estimates range from 20 to over 100. While this affords patients the ability to access new and innovative therapies, both SOMMER and the ICMS are concerned that this continued proliferation of clinics without oversight and regulation poses a significant potential danger to patients. “This alliance,” said Dr. Juan Jose Parcero Valdes, President of SOMMER, “allows the two societies to work together collaboratively to establish the highest possible standards for the practice of adult stem cell medicine in Mexico.”

The goal of this strategic alliance will be to work together, with regulatory and governmental agencies, to apply and adapt the ICMS Standards for the Practice of Stem Cell Medicine to Mexico. “Patient safety is our top priority,” said David Audley, Executive Director of the ICMS. “By working together, SOMMER and the ICMS will provide a way for patients and regulators, to identify clinics whose practices are based on good patient care. Clinics can show their commitment to patient safety by embracing these standards and opening up their treatments to transparency and peer oversight.” The newly formed alliance will work to identify clinics providing stem cell treatments in Mexico and seek their participation in the ICMS Accreditation Program. This rigorous 18 to 24 month process reviews and evaluates clinics’ entire practice, including an assessment of informed consent procedures, patient candidacy guidelines, clinical and lab processes, and treatment protocols.

“It is nearly impossible for patients to know which clinics are safe and which clinics provide good patient care,” said Dr. Javier Lopez, Director of the Regenerative Medicine Institute (RMI), Mexico, and a member of both SOMMER and the ICMS. RMI is currently the only clinic in Northern Mexico participating in the ICMS accreditation process. “Patients need to know who they can trust, which treatments are legal and which doctors are licensed. This alliance, and work that the two societies will advance, is critical for the future of stem cell medicine in Mexico, and the world.”

# # # #

About the SOCIEDAD MEXICANA de MEDICINE REGENERATIVA

The Sociedad Mexicana de Medicina Regenerativa, A.C. (SOMMER), is a group of dedicated medical professionals which has the mission to further the knowledge, the study, and the practice of Regenerative Medicine and related specialties for the benefit of its members and the general public. SOMMER is committed to furthering the scope of scientific function and capacity for assistance of its members, as well as promoting their academic and cultural improvement through the fostering of scientific knowledge and procuring cultural, humanistic, technical, and scientific exchange with similar societies. SOMMER is dedicated to promoting a forum of expression, as well as facilitating meeting and consultation between members, procuring an environment of democracy, humanism, social justice and freedom of conscience.

The members of the society hold as their first goal and commitment an adherence to the principles of the Helsinki declaration adopted by the World Medical Association (WMA) on ethical principles for medical research on humans, and resolve to not participate in any study or treatment that does not comply with the criteria of being autologous, minimally invasive and without cell culturing or expansion.

SOMMER does not seek profit. The society’s assets are made up from the dues paid by its members and donations or subsidies that it may receive. Its purpose is to maintain, when financially possible, libraries, laboratories and educational centers for study, practice and the general use of its members, as well as to promote scientific, technical and humanistic research in order to achieve a higher level of professional preparation and participation on a national and international level that will lead to the integral development of regenerative and general medicine.

About the INTERNATIONAL CELLULAR MEDICINE SOCIETY

The ICMS is a physician guided international 501(c)(3) nonprofit organization dedicated to the advancement of adult stem cell medicine through patient safety through the collection of patient outcomes from· cell based medical treatments, physician education through the production of global guidelines for the practice of cell based medicine and the accreditation of clinics providing stem cell therapies. The Society maintains two websites,www.cellmedicinesociety.org and www.stemcellwatch.com, a patient focused portal.

MAY 10, 2011. PORTLAND, OREGON

These contracts attest that WSC will provide the utmost level of transparency in regards to its clinical and medical practices. All treatment processes, patient informed consent protocols, and patient candidacy documentation will be reviewed by the institutional review board of the ICMS.  The clinic’s cell collection, processing, and implantation practices will all be examined for compliance with the ICMS Best Practice Guidelines. Additionally, all patients treated with stem cells by WSC will be entered into the ICMS Treatment Registry for outcome and complication tracking.  If, at the end of this rigorous 18 month program, the clinic passes all compliance measures, lab audits, and reporting standards, WSC will receive full accreditation from the ICMS.

“We at World Stem Cells, LLC are very pleased to take the steps necessary to formally engage with the ICMS, in the accreditation program.  We have submitted prior patients into the registry, having recognized the need for transparency, from the onset of our clinic treatments. Our state of the art laboratory and the association with Amerimed hospitals gives us unique opportunities to excel in stem cell treatments,” says Dr. Alan Kadish, President of WSC.

Dra. Sylvia Abblitt, the Medical and Laboratory Director of Advanced Cellular Medical Clinic shares the same enthusiasm.   “Our expansion and engagement with ICMS is a groundbreaking event for Mexican involvement in international stem cell therapeutics,” said Dra. Abblitt. “Our years of experience will be well represented within the registry.”

World Stem Cells has its contracted clinical facility Advanced Cellular Medicine Clinic in the heart of the medical district of Cancun.  The clinic provides quality stem cell therapies including the use of bone marrow, cord and adipose for harvesting of stem cells. Advanced Cellular Medicine’s medical team of exclusively board certified specialists provides specific stem cell therapeutics for a number of well-researched disorders.

A full explanation of the ICMS Accreditation program can be found at the ICMS website.

APRIL 19, 2010. PORTLAND, OREGON

Over the course of the next four months, the ICMS will be sending this letter across the globe to all clinics offering cellular therapy, calling on them to embrace the organization’s standards and guidelines and submit themselves to a formal independent evaluation.  The process of evaluation and accreditation of these clinics will be overseen by the ICMS Medical Advisory Board and Treatment Oversight Committees. These volunteer groups are comprised of physicians and researchers with significant domain expertise in specific condition treatment and cell based medicine.

“Clinics need to know that the ICMS is watching and that we will expose those clinics that refuse to submit to oversight by the international medical community,” says David Audley, Executive Director of the ICMS. “Transparency, independent evaluation and accreditation is the only appropriate response to the growth of these innovative treatments.  As a patient, I would be very wary of any clinic that failed to meet the minimum standards of the ICMS, or refused to participate in the accreditation process. For clinics, this is the only way to truly demonstrate their commitment to patient safety and good patient care.”

The complete version of the letter can be found HERE

PORTLAND, OREGON. APRIL 14, 2011 — Today, the International Cellular Medicine Society, the global leader in providing best practice standards for cell based medicine, announced the initiation of its first step toward conducting worldwide evaluations of current stem cell treatment offerings.  This step, the creation of a new ICMS Treatment Oversight Committee (TOC), is the first of many that will guide a global effort to bring oversight and transparency to cell based medical treatments.

The TOC will serve as a sub-committee under the ICMS Medical Advisory Board. The committee is tasked with reviewing and evaluating protocols and methodologies being utilized by clinics that are providing stem cell treatments. “Patient safety is our key concern,” said David Audley, Executive Director of the ICMS. “Without oversight and independent evaluation of these treatments, there is no way to distinguish between those that are promising and those that are deceitful and potentially harmful.”

The ICMS has identified Parkinson’s as the first condition to be investigated.  Parkinson’s disease is illustrative of the issues surrounding cell based medicine.  It is a condition that holds tremendous promise for treatment with stem cell, while at the same time poses great potential risks due to a lack of supportive data for these treatments.  The ICMS has identified nearly a dozen clinics around the world currently offering stem cell treatments for this condition.

Comprised of specialists in cell based medicine,  as well as physicians and scientists with significant domain expertise in Parkinson’s disease, the newly formed TOC is tasked with the responsibility of evaluating the data that the ICMS will be collecting from clinics worldwide.  The TOC will generate a report that will provide an evaluation of the current treatments, general guidelines for the applicability of stem cells in the treatment of Parkinson’s disease and methodologies for judging the outcomes of these treatments.

“Our mission is to bring transparency to the field,” continued Audley. “No one knows which clinics are peddling false hope, or whether or not there are any viable treatments available for patients. This is only attempt to evaluate what is available, and separate the credible from the malicious.”

The results and learnings from this global treatment evaluation of Parkinson’s disease will serve to form a model for future evaluations of other conditions.

The ICMS Treatment Registry has reached 750 stem cell patient cases being tracked.

The 750 patients have all received autologous adult stem cell treatments and have been tracked in the ICMS Treatment Registry, a secure, web-based data collection system that tracks patient-reported outcomes and complications from patient surveys and interviews at 3, 6, and 12 months, and 2, 3, 4, 5, 10 and 20 years after the treatment.  The rate of complication from these treatments has been less than 2%, and no severe adverse events have been reported.

While the ICMS has collected tremendous amounts of data, the organization is adamant about maintaining the privacy of the patients and the confidentiality of the treatment protocols. The data stored in the Registry, including the processes by which the cells are collected and administered, as well as specific patient outcomes, are secure, private and available only to the clinic, the patient and select reviewers of the ICMS. These reviewers, in turn, only access Registry data to evaluate protocols and audit patient outcomes, and are bound by strict confidentiality and nondisclosure agreements. Individual members of the ICMS have no access to either patient data or the confidential processes that clinics utilize to treat patients. The ICMS does not publish outcomes from specific clinics. The ICMS does, however, publish all unadjudicated complaints and findings resulting from investigations on reported severe adverse events.

To read the full press release please follow the link.

Click HERE to learn more about the ICMS Treatment Registry.

MARCH 31, 2011. PORTLAND, OREGON – The International Cellular Medicine Society has accomplished a significant milestone through its Stem Cell Patient Treatment Registry.  Today the Society announced that the ICMS Treatment Registry has reached over 750 patient cases being tracked.  As a nonprofit organization dedicated to ensuring patient safety, facilitating physician education, and providing peer oversight, this level of oversight and transparency is a significant landmark for the  for the field and promise of cell based medicine.

“Patient safety is the foundation of the ICMS,” said Ricardo Rodriguez, MD, a director of the ICMS and co-chair of the Medical Advisory Board. “Through best practice standards, clinic accreditation and now this sizeable pool of patient outcome and complication data, the ICMS has established itself as the premiere organization in advancing adult stem cell treatments that are based on the principals of good patient care.” Participation in the Treatment Registry is reserved for those clinics that meet the Society’s minimum standards and been reviewed by the ICMS Institutional Review Board.

The 750 patients have all received autologous adult stem cell treatments and have been tracked in the ICMS Treatment Registry, a secure, web-based data collection system that tracks patient-reported outcomes and complications from patient surveys and interviews at 3, 6, and 12 months, and 2, 3, 4, 5, 10 and 20 years after the treatment.  The rate of complication from these treatments has been less than 2%, and no severe adverse events have been reported. “To have this number of patients and have a rate of complications this low speaks to the safety profile of self-donated cells,” said David Audley, the Executive Director of the ICMS.

While the ICMS has collected tremendous amounts of data, the organization is adamant about maintaining the privacy of the patients and the confidentiality of the treatment protocols. The data stored in the Registry, including the processes by which the cells are collected and administered, as well as specific patient outcomes, are secure, private and available only to the clinic, the patient and select reviewers of the ICMS. These reviewers, in turn, only access Registry data to evaluate protocols and audit patient outcomes, and are bound by strict confidentiality and nondisclosure agreements. Individual members of the ICMS have no access to either patient data or the confidential processes that clinics utilize to treat patients. The ICMS does not publish outcomes from specific clinics. The ICMS does, however, publish all unadjudicated complaints and findings resulting from investigations on reported severe adverse events.

The ICMS expects the number of patients tracked to increase rapidly and significantly with the recent launch of its Stem Cell Clinic Accreditation Program.  As the field of cell based medicine continues to advance and the number of clinics offering stem cell treatments around the world grows, the need for the services of the ICMS as trusted and independent authority to collect patient data and evaluate clinics will expand.

More information about the ICMS Registry and Clinic Accreditation Program can be found HERE

Regenerative Medicine Institute (RMI) of Tijuana, Mexico is the first clinic participant in the recently launched ICMS Stem Cell Clinic Accreditation Program.

RMI is based out of Hospital Angeles Tijuana, a fully equipped state-of–the-art private specialties hospital. The clinic claims to provide high quality chronic disease treatments centered around patient dignity and safety.· Its medical team of board certified specialists provides adipose-derived stem cell therapies to patients. Under its agreement with the ICMS, RMI will provide an unprecedented level of transparency into its clinical and medical practices. All treatment protocols, as well as patient informed consent and patient candidacy documentation will be reviewed by the institutional review board of the ICMS.

As part of the accreditation process, the ICMS will be investigating every aspect of the clinics practices, processes, and protocols.  RMI’s patient candidacy protocols, informed consent process, and cell collection, processing, and implantation practices will all be examined for compliance with the ICMS Best Practice Guidelines.  To read the full press release click HERE.

MARCH 15, 2011. PORTLAND, OREGON

Under this agreement, RMI will provide an unprecedented level of transparency into its clinical and medical practices. All treatment protocols, as well as patient informed consent and patient candidacy documentation will be reviewed by the institutional review board of the ICMS. “This accreditation process is unique.” says David Audley, Executive Director of the ICMS. “This is the only program to bring global best practice standards to cell based medical clinics. It is an important step for this emerging field of medicine and a critical step for patient safety.”

As part of the accreditation process, the ICMS will be investigating every aspect of the clinics practices, processes, and protocols.  RMI’s patient candidacy protocols, informed consent process, and cell collection, processing, and implantation practices will all be examined for compliance with the ICMS Best Practice Guidelines. Additionally, all RMI patients treated with stem cells will be entered into the ICMS Treatment Registry for outcome and complication tracking.  If, at the end of this rigorous 18 month program, RMI passes all compliance measures, lab audits, and reporting standards, the clinic will receive full accreditation from the ICMS.

“RMI welcomes the opportunity to participate in this program,” says Dr. Javier Lopez, President and CEO of RMI. “Patient safety is the highest priority of all of our physicians and staff.  We have no doubt that our clinic will be a model for others to emulate.”

Regenerative Medicine Institute is based out of Hospital Angeles Tijuana, a fully equipped state-of–the-art private specialties hospital.  The clinic claims to provide high quality chronic disease treatments centered around patient dignity and safety.  Its medical team of board certified specialists provides adipose-derived stem cell therapies to patients.

RMI is the first of a handful of clinics worldwide that have agreed to participate in this accreditation program. The ICMS will be announcing other clinic participants in the coming weeks. A full explanation of the ICMS Accreditation program can be found here.

The ICMS has assembled a Medical Advisory Board to serve as a leadership role in the continued development of ICMS Clinical Guidelines, Practice Standards, and Adjudication Review for stem cell treatments.  The Medical Board is made up of physicians and researchers from academic institutions, hospitals, and private practices around the world.  It is the hope of the ICMS that this Board will make certain that the guidelines and practice standards of the Society ensure patient safety through peer oversight and transparency.

A list of members of the Medical Advisory Board can be found HERE.
Click HERE to read the full press release.

Prominent group of physicians and researchers to provide leadership and oversight.

PORTLAND, OREGON, MARCH 1, 2011 – The International Cellular Medicine Society (ICMS), an international nonprofit organization dedicated to patient safety, physician education, and peer oversight,  announced today the creation of a new Medical Advisory Board.  The Society has created this board to provide a leadership role in its continuous development of clinical guidelines, practice standards, and adjudication review for cell based medical therapies.

The newly formed ICMS Medical Advisory Board comprised of physicians from major academic institutions, hospitals and private practices from around the globe. “The goal of the Medical Board,” said David Audley, Executive Director of the ICMS, “Is to work to make certain that the guidelines and practice standards of the ICMS ensure patient safety through peer oversight and transparency.”

One of the most important functions of the Medical Advisory Board will be to oversee the Clinic Accreditation Process that the ICMS announced earlier this week. Members of the Medical Advisory Board will review the protocols and evaluate the patient outcome data from clinics seeking accreditation. “With the proliferation of clinics worldwide,” said Dr Keith March, MD, PhD, a member of the Medical Advisory Board and the Board of Directors of the ICMS, “The need to have strict standards and independent review of practices for stem cell clinics is critical.”

A detailed list of the members of the Medical Advisory Board can be found on the ICMS website.