FOR IMMEDIATE RELEASE

Contact: David Audley
503.877.1045
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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.

FOR IMMEDIATE RELEASE

Contact: David Audley
503.877.1045
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www.cellmedicinesociety.org

International Society Announces Agenda for 4^th·International Congress for Regenerative and Cell-Based Medicine

PORTLAND, OREGON - Tuesday, November 8, 2011. The International cellular Medicine Society (ICMS), an international nonprofit dedicated to advancement of cell-based therapies through physician education, peer oversight and patient safety, announced the preliminary agenda for the 4^th Annual International Congress for Regenerative and Cell- Based Medicine.· The two day congress, to be held on May 3 -4· in Hollywood, Florida, will feature speakers from around the world who are actively engaged in the safe clinical translations of cells for the treatment of patients.

“This is a unique congress,” said David Audley, Executive Director and CEO of the ICMS, “While there are literally dozens of conferences about primary research and the science of stem cells, this is the only congress that is focused on what is happening in the clinic today.”

The proposed agenda is:

Thursday, 3 May 2012 from 8 AM to 5 PM – Stem Cells in the Clinic

 Understanding Regenerative Medicine

A Global Approach to Regenerative Medicine

Safety Issues in Stem Cell Therapies: Results from the ICMS Treatment Registry

Understanding the legal and policy challenges to cell-based medicinStem Cell Medicine – Neuro-Degenerative Disease

Stem Cell Medicine – Auto-Immune Disorders

Stem Cell Medicine – Orthopedic Conditions

Stem Cells in Medicine – Cardiology

From Bench to Bedside: Clinical Translation of Innovative Therapies

Emerging Trends in Cell Banking·

Thursday: 6 PM - 8:30 PM ICMS Member Meeting

Friday 4 May 2012 from 7 AM to 8:30 PM Special Session - Emerging Global Markets - Round Table Discussions

 South America·

Asian·

Middle East

Europe

Friday 4 May 2012 from 9 AM to 12 PM – Stem Cells in Practice of Medicine

 Track 1: Emerging Concepts in Regenerative Medicine

Mixing Modalities: Cells, Devices and Physicians·

 Homing Properties of Stem Cells

Crossing the Blood Brain Barrier

Pulmonary First Pass and Stem Cells

Allogeneic Stem Cells in Patient Treatment

Track 2: Platelet Rich Plasma

PRP and Wound Treatment

PRP and Sport Medicine

PRP and Disease Therapy

Friday 4 May 2012 from 1 PM - 5 PM – Stem Cells in Practice of Medicine (General Sessions)

 To Culture or Not: Overview of Data for Comparison

Adipose, Peripheral or Marrow: What to Use and When

Regenerative Medicine: The Advocacy Agenda for the Coming Years

Defining Clinical Translation: When is a therapy ready for Prime Time?

Systemic versus Local: What Role does Placement Play in Stem Cells?

The 4^th Annual International Congress for Regenerative and Cell- Based Medicine is presented by the ICMS and the Age Management Medicine Group (AMMG) and will be hosted at the Westin Diplomat in Hollywood, Florida.

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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.

FOR IMMEDIATE RELEASE

Contact: David Audley
503.884.6590
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
www.cellmedicinesociety.org

International Society Initiates Investigation into Patient Death

PORTLAND, OREGON - Monday, October 31, 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 it had opened an investigation into a 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 patient who expired was a 74 year old male from the United States. The patient was being treated in an open-label, non-randomized and multi-center study to assess the safety and effects of intra-venous implantation of stem cells in patients with pulmonary fibrosis.· The patient expired 36 days after the treatment and the cause of death has been attributed to an infection.

In accordance with ICMS Guidelines, the Society was alerted by the clinic within 48 hours of learning about the patient’s death. The clinic requested that the ICMS investigate the death and is cooperating fully. The clinic has voluntarily halted all treatments within this study until this investigation is completed. ·“The death of any patient is a serious matter,” says David Audley, Executive Director and CEO of the ICMS. “Our goal is to complete a full and independent investigation to determine the cause of this death.”

The ICMS is now in the process of compiling an investigative team of ICMS members, specialists from outside the Society and individuals from regulatory and professional oversight organizations. The ICMS anticipates an initial review of the patient’s file early this week with a preliminary report to be published after a thorough examination of the process and protocols associated with this patient’s treatment.

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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.

Currents in Stem Cell Medicine

October, 18 2011. Vol 1, Ed 5.

News from the ICMS

Federal Trade Commission (FTC) and Stem Cell Medicine:

The FTC is a large regulatory agency with very broad powers. If you market your services as a physician or offer medical therapies then the FTC can claim jurisdiction. If your ‘marketing’ is in English, it does matter if your clinic or your practice is in Peru, Mexico or China. The FTC is watching and evaluating the claims around stem cell medicine.

The ICMS met with the compliance office of the FTC last week to open a dialogue to provide physician and stem cell therapy providers with information to help them navigate the fine line between patient education and patient recruitment. The simple fact is this: You are subject to Truth in Advertising Laws. And because of the sensational nature of many ‘claims’, the murky regulatory nature about what is legal according to the FDA, and the proliferation of clinics in the US and abroad, our field is under considerable scrutiny. As a field, there are a few basic standards that we should all be working within:

1. Any claim must be based upon scientific evidence and knowledge that is generally accepted in the field, and

1. Any claim must be reliable and be shown to consistently reproduce similar results.

Any claim brought before the FTC will be evaluated by experts in the field. The ICMS is working hard to establish our membership as experts to be consulted to evaluate any claim. To do this, we will work collaboratively with the federal government of the USA to develop standards for patient recruitment and appropriate use of medical claims.

If you are currently promoting a therapy on your website, we suggest that you evaluate it to assure that you are in compliance with Truth in Advertising Standards and seek legal counsel if you have any questions.  We will continue to work to provide you with guidelines and standards so that we, as a peer organization, can define the future of cell-based medicine. If you are interested in serving on the committee to help draft these standards, please contact the ICMS.

Join the ICMS and Help Define the Future of Stem Cell Medicine

Latest Stem Cell News

EU Court Bars Stem Cell Patents When Embryos Destroyed

Europe’s highest court has ruled that stem cells from human embryos cannot be patented, in a case that could have major implications for medicine.

Stem cell discovery could treat problem at the core of MS

Scientists have honed in on the stem cell that may be able to treat the brain problem at the core of multiple sclerosis (MS). Researchers at the universities of Rochester and Buffalo have isolated and directed stem cells from the human brain to become oligodendrocytes, which make the crucial fatty myelin that coats neurons and allows them to travel through the brain effectively.

Stem Cell Doctor From Nevada Pleads Not Guilty

Stem cell doctor Ralph Conti pleaded not guilty to charges that he and a man pretending to be a doctor attempted to implant stem cells harvested from human placentas in chronically ill patients.

Scientists Use Rats’ Own Stem Cells to Cure Their Diabetes

Using stem cells that they extracted from the brains of diabetic lab rats, and turning them into insulin-producing pancreatic cells, Japanese scientists may be on the road to a virtual cure for diabetes that comes from people's own brains.

MRI-based technique allows researchers to follow neural stem cells in vivo

Carnegie Mellon University biologists have developed an MRI-based technique that allows researchers to non-invasively follow neural stem cells in vivo.

Stem cell research in Austin

Austin-based St. David’s HealthCare and Temple-based Scott & White Healthcare are investing in and dedicating resources to adult stem cell-related research, as opposed to research using embryonic stem cells.

Scientists from the universities of Southampton and Glasgow have uncovered a new method for culturing adult stem cells which could lead to the creation of revolutionary stem cell therapies for conditions such as arthritis, Alzheimer’s disease and Parkinson’s disease. The research, funded by the Biotechnology and Biological Sciences Research Council (BBSRC) and the University of Glasgow* shows how a new nanoscale plastic can cheaply and easily solve a problem which has previously made the expansion of stem cells for therapeutic purposes impossible. Harvested cells need to be increased in volume sufficiently enough to kick-start the process of cellular regeneration when they are reintroduced back into the patient but the process is made more difficult by spontaneous stem cell differentiation, where stem cells grown on standard plastic tissue culture surfaces do not expand to create new stem cells but instead create other cells which are of no use in therapy.

$12 million collaborative grant seeks to improve cord blood transplantation for cancer patients 

Latest Stem Cell Research

Administering human adipose-derived mesenchymal stem cells to prevent and treat experimental arthritis

Rheumatoid arthritis is a chronic autoimmune disease and affecting approximately 1% of the population. Human adipose-derived mesenchymal stem cells (hASCs) were recently found to suppress effector T cell and inflammatory responses and, thus, to have beneficial effects in various autoimmune diseases. In this study, we examined whether hASCs could play a protective and/or therapeutic role in collagen-induced arthritis (CIA).

Xeno-free proliferation of human bone marrow mesenchymalstem cells

The proliferation of human bone marrow mesenchymal stem cells (MSCs) employing xeno-free materials not containing fetal calf serum (FCS) and porcine trypsin was investigated for the regenerative medicine of cartilage using MSCs. Four sequential subcultivations of MSCs using a medium containing 10% FCS and recombinant trypsin (TrypLESelect™) resulted in cell growth comparable to that with porcine trypsin. There was no apparent difference in the cell growth and morphology between two kinds of MSC stored in liquid nitrogen using 10% FCS plus DMSO or serum-free TC protector™. MSCs were isolated from human bone marrow cells, stored in liquid nitrogen, and sequentially subcultivated four times employing conventional materials that included FCS, porcine trypsin, and DMSO, or xeno-free materials that included serum-free medium (MesenCult-XF™), TC protector™ and TrypLESelect™. Cells in the culture using the xeno-free materials maintained typical fibroblast-like morphology and grew more rapidly than the cells in the culture using the conventional materials, while the cell surface markers of MSCs (CD90 and CD166) were well maintained in both cultures.

Potential of nucleofected human MSCs for insulin secretion.

The goal of this experiment was to generate insulin-producing human mesenchymal stemcells (hMSCs) as a therapeutic source for type I diabetes mellitus, which is caused by insulin deficiency due to the destruction of islet β cells. In various trials for the treatment of type I diabetes, cell-based therapy using adult stem cells is considered to be one of the most useful candidates for the treatment. In this experiment, a non-viral method called nucleofection was used to transfect hMSCs with pEGFP-C2 and furin-cleavable humanpreproinsulin gene (hPPI) to produce insulin-secreting cells as surrogate β cells.

Differentiation potential of human mesenchymal stem cellsderived from adipose tissue and bone marrow to sinus node-likecells

Adult mesenchymal stem cells (MSCs) hold great promise for the repair of heart defects. Both bone marrow-derived mesenchymal stem cells (BMSCs) and adipose tissue-derivedstem cells (ASCs) are multipotent and may be induced by 5-azacytidine to differentiate into cardiomyocytes. However, the differentiation potential of human MSCs into sinus node-likecells has not been studied extensively.

Oral Stem Cells Used to Regenerate Bone and Colonize Myocardial Tissue in Animals

In recent research studies from Japan and Israel, scientists used stem cells from deciduous teeth, dental pulp, bone marrow and oral mucosa to regenerate mandibular bone in dogs and to colonize infarcted myocardial tissue in rats. The Japanese researchers reported mature bone formation in adult canine mandibles eight weeks after implanting stem cells that were extracted from the deciduous teeth and dental pulp of canine offspring (puppies).

Mesenchymal Stem Cells Restore Frataxin Expression and Increase Hydrogen Peroxide Scavenging Enzymes in Friedreich Ataxia Fibroblasts

Dramatic advances in recent decades in understanding the genetics of Friedreich ataxia (FRDA)—a GAA triplet expansion causing greatly reduced expression of the mitochondrial protein frataxin—have thus far yielded no therapeutic dividend, since there remain no effective treatments that prevent or even slow the inevitable progressive disability in affected individuals. Clinical interventions that restore frataxin expression are attractive therapeutic approaches, as, in theory, it may be possible to re-establish normal function in frataxin deficient cells if frataxin levels are increased above a specific threshold.

Bone Marrow Derived Mesenchymal Stem Cells Inhibit Inflammation and Preserve Vascular Endothelial Integrity in the Lungs after Hemorrhagic Shock

Hemorrhagic shock (HS) and trauma is currently the leading cause of death in young adults worldwide. Morbidity and mortality after HS and trauma is often the result of multi-organ failure such as acute lung injury (ALI) and acute respiratory distress syndrome (ARDS), conditions with few therapeutic options. Bone marrow derived mesenchymal stem cells (MSCs) are a multipotent stem cell population that has shown therapeutic promise in numerous pre-clinical and clinical models of disease.

Differential gene expression profiling of human bone marrow-derived mesenchymal stem cells during adipogenic development

Adipogenesis is the developmental process by which mesenchymal stem cells (MSC) differentiate into pre-adipocytes and adipocytes. The aim of the study was to analyze the developmental strategies of human bone marrow MSC developing into adipocytes over a defined time scale. Here we were particularly interested in differentially expressed transcription factors and biochemical pathways.

The relevance of mesenchymal stem cells in vivo for future orthopaedic strategies aimed at fracture repair

The concept of a stem cell first emerged from studies on haematopoiesis where it was demonstrated that a rare clonogenic highly proliferative bone marrow (BM) cell, the haematopoietic stem cell (HSC), could give rise to all of the blood lineage cells. Hot on the heels of this work was the discovery of a second highly clonogenic and proliferative BM stem cell, later dubbed the mesenchymal stem cell (MSC) that was capable of giving rise to bone and cartilage and other stromal lineages.

Paracrine Molecules of Mesenchymal Stem Cells for Hematopoietic Stem Cell Niche 

Hematopoietic stem cells (HSCs) are rare cells residing in the bone marrow (BM; 1 in 10⁴ to 1 in 10⁸ of BM nucleated cells), and they are progenitors that become progressively restricted to several or single lineages. These progenitors yield blood precursors devoted to unilineage differentiation and the production of mature blood cells, including red blood cells, megakaryocytes, myeloid cells (monocyte/macrophage and neutrophil), and lymphocytes [1, 2]. CD34 surface antigen (CD34⁺) is commonly used as a marker to identify and quantify the population of progenitor cells [3], according to which, sorting HSCs from BM, peripheral blood (PB), and umbilical cord (UC)/placenta blood is relatively simple and practical.Human HSCs are known to exhibit CD34⁺, Thy1⁺, CD38^lo/−, Ckit^−/lo, CD105⁺, and Lin⁻ phenotype. 

Join the ICMS and Help Define the Future of Stem Cell Medicine