StemCell Therapy

An international team of medical experts recently published a global call to action in Science Translational Medicine in an effort to curb the unethical, unsubstantiated use of stem-cell based therapies driving medical tourism. Such ill-advised stem cell treatments have led to pediatric deaths in Germany, blindness in the United States, the closure of Italys Stamina Foundation to name a few as well as a variety of untoward effects given their lack of rigorous testing for safety and efficacy.

With high price tags, so-called stem-cell clinics are designing therapies without evidence that serve to do harm, be ineffective, prey on the most vulnerablepotentially curtailing their ultimate treatment choices, and threaten the legitimate work being done that holds great promise for devastating disease.

When greed trumps science, we all lose.

In The Worst 'Healthcare': 'Stem Cell' Clinics Wrought With Red Flags, Insincerity And Blindness, I detail the distressing accounts of three patients who endured irreparable damage to their vision after seeking treatment at the same unnamed stem cell clinic in Broward, Florida. Reported in the New England Journal of Medicine (NEJM), the harrowing experiences of the women aged 72-88 years old resulted in blindness to near blindness from untested stem cell therapies being injected into their eyes while being fleeced $5000 for the procedures. Promised revolutionary therapy, they were left with catastrophic reminders of the unfortunate and unnecessary ordeal.

Theirs is a cautionary taleof the hazards of poor and irresponsible practice at a private stem cell clinic, unfixable medical interventions with no scientific evidence to back claims, sales over substance, marketing hype lacking in meaning and actions taken by seemingly complicit personnel who may have misrepresented their credentials that took advantage of those most in need. See here for a more detailed road map of how to read between the lines of such marketing hype and to understand the timeline of this particular bad outcome.

Heres the deal with stem cells

Stem cells are currently in use for a rather limited scope of disorders. Ones where the data is well-established and been subject to proper design, rigorous testing and clinical trials. They are also being actively studied, in general. The notion that they can cure every type of medical condition is not one based in our present reality or the near term future. The media tends to overstate where we are in stem cell-based therapeutics.

The safety and efficacy of stem cell use when derived from bone marrow or your peripheral blood is well-established, but stem cells are now being increasingly derived from alternate sources like adipose (aka fatty) tissue and put in use for orthopedic to neurological disorders.

Many in the medical community are enthused about their promise and rightfully so as some advancements are already underway. In my recent article Did Gene Therapy Cure Sickle Cell Disease?, I discuss the hopeful work in autologous stem cell transplantation obtained from bone marrow for this and other hemoglobinopathies. This is further explored in this television appearance:Dr. Jamie Wells On Al Jazeera TV Discussing Sickle Cell Anemia.

Facilities offering false hope often based on the most minimal of clinical evidence are popping up all over the country and world without well-controlled clinical trials or having met any regulatory standards. In the cases of autologous use especiallysince they are your own cells, advocates affirm they are safe. These private stem cell clinics are typically patient-funded at nonacademic centers, are not based on preclinical research or sound design and lack investigational new drug application with the FDAbecause, again, they are your own cells despite the fact what the facility mixes them with are unknown agents that have not been tested to confirm safety.(1)

In a perspective written by the U.S. Food and Drug Administration in the NEJM, the FDA maintains: Outside the setting of hematopoietic reconstitution and a few other well-established indications, the assertion that stem cells are intrinsically able to sense the environment into which they are introduced and addresswhatever functions require replacement or repairwhether injured knee cartilage or a neurologic deficitis not based on scientific evidence. The piece goes on to inform about misadventures of their use and the worrisome lack of evidence in particular in circumstances where therapies proved harmful or ineffective when properly studied.

Hence, why this recent global call to action by worldwide leaders in the field

Buoyed by efforts of the scientific community to impact changes in stem cell facilities in Germany and Italy among others, an international consortium of medical experts outline in their latest publication local to transnational considerations that could limit unchecked marketing claims and unfounded science. Appreciating the current climate of expediting lengthy approval processes, the politics of right to try legislation and direct-to-consumer advertising, the authors contend with respect to sham stem cell therapies under-regulation has led to substantial, reverberating harm.

Due to general regulatory resistance, the panel of fifteen urges a more coordinated approach nationally and internationallythat emphasizes engagement, harmonization and enforcement. Highlighting prior success, the group encourages mobilization of international scientific organizations to create global standards and the utilization of traditional and social media type engagement to expand reach to the public as well as positively influence national policies.

With the main goals of eliminating harmful therapies and preserving a patients ability to seek effective treatment, they identify further the risk of not doing anything will worsen the big problems of destabilizing health markets and delegitimizing biomedical efforts that could genuinely benefit society.

Among their requests for proactive efforts is for groups with broad constituencies like the World Health Organization (WHO) to dispense guidelines in conjunction with national authorities for the responsible use of human cells and tissues which they maintain they already dofor medical devices and medicines. They call for cross-border partnerships for compliance.

Of particular note, the article includes a wonderful chart clarifying where inroads can be made locally, regionally and internationally to prevent the all too frequent co-opting of scientific legitimacy. It can be very difficult for patients to suss out what is fact from fiction when powerful advertising runs amok. Words like revolutionary and clinical trials and expert are consistently thrown around to confuse and can be a challenge for many to unpack accurately.

The authors provide in this graphic tangible ways to cut through the nonsense. By outing deceptive tactics used throughout the commercialization of these products and spreading these protective messages, patients can become empowered and the culture of fleecing might shift. Here, they point out a number of ways scientific integrity gets diminished:the use of renting space in academic facilities as a way to appear legitimate by association, suggestby having a patent application this means the product is proven or tested as opposed to just a sign of an initiation of applying, citing preclinical and other findings to rationalize clinical use without efficacy testing etc. (3) I would argue this list is an excellent tool that could be applied well beyond the stem cell industry. Interventions starting withthis listcould certainly support more honesty.

In conclusion

Though rarely a lover of regulation, in general, given the likelihood of overdoing it, creating more problemsand the tendency for many policies to be one-size-fits-all and misguided, in this realm the price people are paying as well as society could be too great to allow the wild west ways of the stem cell industry to continue as is. The authors in this work provide some meaningful measures to compel a more honest arena.

Source(s):

Read the original:
Fraud Alert! Unproven Stem Cell Use Prompts International Call to Action - American Council on Science and Health

In 2014, during a speech in Manchester, Amanda Grappone Osmer made a startling admission.

I know why you hate me, she began, when it came her time to speak at TEDx Amoskeag Millyard. You all have memories of someone like me that takes you back to a time and place that you wish you didnt have to think about.

Your palms start to sweat. Your stomach is in a knot. Like me, your heart races. You just have an overall feeling of dread.

Mentally, you start to make a tally when you see me coming of all the ways you might get ripped off.

She describes further this experience with her at its center.

When you see me, you load up for bear. Because you know you need to, just to get through our conversation, she says.

You hate me because I am a car salesman. A fourth-generation car salesman.

And with a deep breath, she adds, I understand.

Osmers speech spoke to a stereotypical experience someone might have purchasing a car, an experience that she likened to being under the ether and one that her companys philosophy seeks to counter. Her personal mission and that of Grappone Automotive Group in Bow, for which she is CEO, moves well past the showroom to all aspects of the business, employee relationships and the manner in which she leads an engaged community life.

The business mission: Dedication to building lifelong relationships with our team members, guests and community by serving with integrity, kindness and respect.

And ingrained among her personal objectives is being a little bit better than the day before.

Osmer, the keynote speaker for The Keene Sentinels Extraordinary Women Awards on Aug. 24, graduated from the University of New Hampshire with a degree in humanities. In her teens, she worked at her familys dealership, which was started by her great-grandparents in Concord in 1924 as a Gulf service station. It is now five dealerships. But, despite her early work at the dealership, Osmer didnt envision a future for herself in the cars.

In 2001, after school and marriage, she moved to the West Coast, to the North Bay region of San Francisco. Her marriage ended after a short time, leaving her uncertain what to do next. She applied for all sorts of jobs with no luck, she says. Needing something and knowing something about cars, she found herself selling for Lexus of Marin.

I had never sold anything in my life, she says from her second-floor office at Grappones Toyota franchise, not far from the end of Interstate 89. Her notion of sales, she says, was all wrong, and she learned, You have to be nice to people and honest, and you will earn their business.

Three years later, she was back at her family dealership, in charge of fixed operations service, paint and collision. She described this as the hardest job of my life.

It was difficult to find technicians who met company standards, and there were myriad other workforce challenges, not the least of which is that few women run collision and service centers.

I knew nothing about that world, she recalls. It was constant stress.

But it was in this role that she discovered new ways of doing things that would change her and the company she would come to run. She found a mentor in Jeffrey Liker, the author of The Toyota Way, a best-seller at more than 650,000 copies and translated into 27 languages.

Liker, with whom Osmer corresponds, is professor of industrial and operations engineering at the University of Michigan and has written extensively about how Toyotas manufacturing processes employed principles to reduce waste, boost efficiency and create collaborative workforces to solve problems. He has also profiled other companies using these strategies and measurements, first pioneered by W. Edwards Deming in post-World War II Japan.

I fell in love with lean manufacturing, says Osmer, referring to the umbrella term under which these principles exist.

She opens Likers book frequently; her copy is dog-eared, heavily highlighted and fingerprinted and never far from reach. There are, in the lean world, seven categories of waste transport, inventory, motion, waiting, overproduction, over-processing and defects.

Osmer considers it one of her lifes highlights being invited to speak at the headquarters of Dupont in Delaware at a gathering of collision center specialists a conference at which Liker was speaking, too.

Shes asked if Grappone is an efficient operation.

Its a goal, she says candidly, referring to a never-ending focus on continuous improvement.

From the service operation, Osmer was promoted to COO and director of sales. The sales process was going through a similar evolution, she says.

We had peeled away from the current (traditional) way of doing things, she says, referring to the industry standard of commission-based selling. We had to figure out what is our way I really started to notice that we didnt have anyone recognizing the human experience.

The company hired a director of corporate potential a key decision and embarked on strategic planning that led to an unusual, if not dramatically different approach to business. Its primary commitment, she says, is to Grappones 340 employees. They come first in the mission statement by design. Second, the company seeks lifelong relationships with customers and believes this is best achievable if the sales and service experience is not one of negotiation. This, she says, creates integrity and expectations of consistent treatment. Theres a set price for everything, including financing terms. Everyone pays the same, removing the ether to which she referred in her TEDx speech.

Her sales team does not operate on commissions.

It didnt make sense to race to the bottom on pricing, she says.

Having Toyota as a flagship franchise was helpful; expectations of franchises are reasonable, she says, allowing room for Grappones way.

Always trying to be less wasteful as a company, Osmer said an eighth measure of waste also became a Grappone focus the waste of human creativity. Maybe more than any of the other principles, Osmer emphasizes a workplace that allows innovation to occur. As she describes ways this has been manifested, Ron Malachi, the companys inventory pricing specialist, walks by her office.

He ducks in when asked and rattles off several recent problems a team of folks has solved, including storing extra car inventory at a nearby indoor sports facility.

They get some income, and we get a place (to keep the cars), he says.

Osmer is one of five children born to Robert and Beverly Grappone. Her younger brother, Greg, was her only sibling to be part of the business, eventually becoming the groups chief information officer.

Greg, who had health challenges early in his life, developed cutaneous T-cell lymphoma in his 30s. He found he needed a blood stem cell transplant when the disease turned aggressive.

Osmer was a match for the transplant. Treatment involved eradicating Gregs immune system and injecting new stem cells through a transfusion of Osmers blood. The cancer was killed, but a gruesome side effect graft versus host disease took hold. Osmer described the horrific condition that transpired as one that literally hardened his tissues.

Greg died in 2015, leaving behind a wife and a two-year-old daughter.

In his name, Osmer works on a project that would develop a six-mile abandoned rail line into a new bike and walking path that connects to the Northern Rail trail and would link Concord to Lebanon. It is but one page in her deep portfolio of community work.

She says this involvement in social causes is informed by her familys work.

We were always taught its not about us, she says. Dad just didnt get hung up on material things. I dont get upset when I dont have more things. Its better to express me through how much I help people.

She sees herself as dedicated to serving a lot of people, and it starts with the employees, as the mission suggests.

People need to feel safe; psychological safety, physical safety and having flexibility, she says, describing how the company culture is modeled.

In such an environment, creativity is unleashed, efficiencies are found and people are retained. That environment includes an immaculate, welcoming Toyota dealership building that features a grand piano on its second floor a gift to Osmer from her grandfather.

So, its not a surprise that her team of six directors has more than 140 years of collective service to Grappone.

Away from the dealership, Osmers list of community-service positions is extensive and includes: board member, New Hampshire Public Broadcasting System; corporator, Canterbury Shaker Village; board member, The Endowment for Health; member, Partners for Community Wellness; member, New Hampshire Lemon Law Board; advisory member, Spark New Hampshire; advisory member, Stay Work Play New Hampshire; and advisory member, New Hampshire Charitable Foundations New Hampshire Tomorrow Initiative.

Recently, she became involved in President Donald Birx move to reorganize Plymouth State University into seven educational clusters, beginning this fall. They are: arts and technology; education, democracy and social change; exploration and discovery; health and human enrichment; innovation and entrepreneurship; justice and security; and tourism, environment and sustainable development.

I try to go where I can be most useful, she says, adding she prefers, in many cases, serving one term on a board rather than more to allow broader service.

Osmer lives with her husband, Tom, and three children (two girls and a boy) in a log home in Canterbury. The community, known for its Shaker history, suits her in many ways, from the caring she can expect from the Canterbury Library staff if she drops her son off some afternoon, to the wooded setting that allows her to indulge in trail running, to the neighborly warmth of the Canterbury Fair, recently held.

And, its just the right setting to play her banjo, her instrument of choice.

Osmers is a life being well lived and one seemingly grounded in the words she used to finish her TEDx speech.

So, this is not just about car sales. Its not just about a fourth-generation family business in Bow Junction, New Hampshire, she says. Ask yourselves. Do integrity, kindness and respect form the foundation of all of your relationships, with the people you love the most, with the people you work with, with the people you meet every day? Do they?

If they dont, dont worry about it, she says. Just know that you are under the ether with all of the rest of us. And its time to wake up.

See the rest here:
Amanda Grappone Osmer breaks down car sales stereotypes with focus on kindness, integrity - The Keene Sentinel

Michael Joyce is a multimedia producer at HealthNewsReview.org and tweets as @mlmjoyce

Ten years ago this probably wouldnt even have been a topic of conversation.

If it had, it likely would have been about medical tourism. There wouldve been outrage directed at third world countries who allow unregulated and unproven stem cell therapies to be offered to desperate patients.

Well, that concern is now closer to home.

There are now hundreds of such clinics across the U.S. The number of clinics is growing, more people are being hurt, state and federal oversight is shockingly inadequate, and the question has become urgent: What can we do about it?

Thats precisely why we produced a recent podcast and sought out the perspectives of these people:

Its also why were hosting a Tweet chat about stem cells that will bring together journalists, stem cell researchers, ethicists, and hopefully many patients and family members.

The chat will be held on Wednesday, August 9 from 2 to 3 p.m. EDT under the hashtag #stemcellhype.

Questions well be discussing during the chat include:

Stem cell therapies when properly researched and applied hold great promise. That makes it all the more critical to openly discuss stem cell interventions that are not evidence-based, not regulated, promoted in misleading ways, and have the potential to cause harm.

Please join the conversation!

Only 7 percent of orthopedic surgeons in the United States are women. Dr. Julie Switzer

Paul Knoepfler PhD is "disturbed and concerned." Here's why. Knoepfler is a stem cell researcher

Stem cell clinics are booming. And hurting people. How can patients protect themselves in a

See the rest here:
Stem cell hype: Join the conversation - HealthNewsReview.org

Stem cell science involves many technical terms. This glossary covers many of the common terms you will encounter in reading about stem cells.

Adult stem cellsA commonly used term for tissue-specific stem cells, cells that can give rise to the specialized cells in specific tissues. Includes all stem cells other than pluripotent stem cells such as embryonic and induced pluripotent stem cells.

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AutologousCells or tissues from the same individual; an autologous bone marrow transplant involves one individual as both donor and recipient.

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Basic researchResearch designed to increase knowledge and understanding (as opposed to research designed with the primary goal to solve a problem).

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BlastocystA transient, hollow ball of 150 to 200 cells formed in early embryonic development that contains the inner cell mass, from which the embryo develops, and an outer layer of cell called the trophoblast, which forms the placenta.

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Bone marrow stromal cellsA general term for non-blood cells in the bone marrow, such as fibroblasts, adipocytes (fat cells) and bone- and cartilage-forming cells that provide support for blood cells. Contained within this population of cells are multipotent bone marrow stromal stem cells that can self-renew and give rise to bone, cartilage, adipocytes and fibroblasts.

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CardiomyocytesThe functional muscle cells of the heart that allow it to beat continuously and rhythmically.

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Clinical translationThe process of using scientific knowledge to design, develop and apply new ways to diagnose, stop or fix what goes wrong in a particular disease or injury; the process by which basic scientific research becomes medicine.

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Clinical trialTests on human subjects designed to evaluate the safety and/or effectiveness of new medical treatments.

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Cord bloodThe blood in the umbilical cord and placenta after child birth. Cord blood contains hematopoietic stem cells, also known as cord blood stem cells, which can regenerate the blood and immune system and can be used to treat some blood disorders such as leukemia or anemia. Cord blood can be stored long-term in blood banks for either public or private use. Also called umbilical cord blood.

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CytoplasmFluid inside a cell, but outside the nucleus.

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DifferentiationThe process by which cells become increasingly specialized to carry out specific functions in tissues and organs.

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Drug discoveryThe systematic process of discovering new drugs.

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Drug screeningThe process of testing large numbers of potential drug candidates for activity, function and/or toxicity in defined assays.

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EmbryoGenerally used to describe the stage of development between fertilization and the fetal stage; the embryonic stage ends 7-8 weeks after fertilization in humans.

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Embryonic stem cells (ESCs)Undifferentiated cells derived from the inner cell mass of the blastocyst; these cells have the potential to give rise to all cell types in the fully formed organism and undergo self-renewal.

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FibroblastA common connective or support cell found within most tissues of the body.

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GlucoseA simple sugar that cells use for energy.

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HematopoieticBlood-forming; hematopoietic stem cells give rise to all the cell types in the blood.

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ImmunomodulatoryThe ability to modify the immune system or an immune response.

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Induced pluripotent stem cells (iPSCs)Embryonic-like stem cells that are derived from reprogrammed, adult cells, such as skin cells. Like ESCs, iPS cells are pluripotent and can self-renew.

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In vitroLatin for in glass. In biomedical research this refers to experiments that are done outside the body in an artificial environment, such as the study of isolated cells in controlled laboratory conditions (also known as cell culture).

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In vivoLatin for within the living. In biomedical research this refers to experiments that are done in a living organism. Experiments in model systems such as mice or fruit flies are an example of in vivo research.

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Islets of LangerhansClusters in the pancreas where insulin-producing beta cells live.

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MaculaA small spot at the back of the retina, densely packed with the rods and cones that receive light, which is responsible for high-resolution central vision.

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Mesenchymal stem cells (MSCs)A term used to describe cells isolated from the connective tissue that surrounds other tissues and organs. MSCs were first isolated from the bone marrow and shown to be capable of making bone, cartilage and fat cells. MSCs are now grown from other tissues, such as fat and cord blood. Not all MSCs are the same and their characteristics depend on where in the body they come from and how they are isolated and grown. May also be called mesenchymal stromal cells.

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Multipotent stem cellsStem cells that can give rise to several different types of specialized cells in specific tissues; for example, blood stem cells can produce the different types of cells that make up the blood, but not the cells of other organs such as the liver or the brain.

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NeuronAn electrically excitable cell that processes and transmits information through electrical and chemical signals in the central and peripheral nervous systems.

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Pancreatic beta cellsCells responsible for making and releasing insulin, the hormone responsible for regulating blood sugar levels. Type I diabetes occurs when these cells are attacked and destroyed by the body's immune system.

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PhotoreceptorsRod or cone cells in the retina that receive light and send signals to the optic nerve, which passes along these signals to the brain.

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PlaceboA pill, injection or other treatment that has no therapeutic benefit; often used as a control in clinical trials to see whether new treatments work better than no treatment.

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Placebo effectPerceived or actual improvement in symptoms that cannot be attributed to the placebo itself and therefore must be the result of the patient's (or other interested person's) belief in the treatment's effectiveness.

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Pluripotent stem cellsStem cells that can become all the cell types that are found in an embryo, fetus or adult, such as embryonic stem cells or induced pluripotent (iPS) cells.

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Preclinical researchLaboratory research on cells, tissues and/or animals for the purpose of discovering new drugs or therapies.

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Precursor cellsAn intermediate cell type between stem cells and differentiated cells. Precursor cells have the potential to give rise to a limited number or type of specialized cells. Also called progenitor cells.

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Progenitor cellsAn intermediate cell type between stem cells and differentiated cells. Progenitor cells have the potential to give rise to a limited number or type of specialized cells and have a reduced capacity for self-renewal. Also called precursor cells.

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Regenerative MedicineAn interdisciplinary branch of medicine with the goal of replacing, regenerating or repairing damaged tissue to restore normal function. Regenerative treatments can include cellular therapy, gene therapy and tissue engineering approaches.

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ReprogrammingIn the context of stem cell biology, this refers to the conversion of differentiated cells, such as fibroblasts, into embryonic-like iPS cells by artificially altering the expression of key genes.

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Retinal pigment epitheliumA single-cell layer behind the rods and cones in the retina that provide support functions for the rods and cones.

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RNARibonucleic acid; it "reads" DNA and acts as a messenger for carrying out genetic instructions.

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Scientific methodA systematic process designed to understand a specific observation through the collection of measurable, empirical evidence; emphasis on measurable and repeatable experiments and results that test a specific hypothesis.

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Self-renewalA special type of cell division in stem cells by which they make copies of themselves.

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Somatic stem cellsScientific term for tissue-specific or adult stem cells.

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Stem cellsCells that have both the capacity to self-renew (make more stem cells by cell division) and to differentiate into mature, specialized cells.

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Stem cell tourismThe travel to another state, region or country specifically for the purpose of undergoing a stem cell treatment available at that location. This phrase is also used to refer to the pursuit of untested and unregulated stem cell treatments.

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TeratomaA benign tumor that usually consists of several types of tissue cells that are foreign to the tissue in which the tumor is located.

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TissueA group of cells with a similar function or embryological origin. Tissues organize further to become organs.

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Tissue-specific stem cellsStem cells that can give rise to the specialized cells in specific tissues; blood stem cells, for example, can produce the different types of cells that make up the blood, but not the cells of other organs such as the liver or the brain. Includes all stem cells other than pluripotent stem cells such as embryonic and induced pluripotent cells. Also called adult or somatic stem cells.

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TotipotentThe ability to give rise to all the cells of the body and cells that arent part of the body but support embryonic development, such as the placenta and umbilical cord.

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Translational researchResearch that focuses on how to use knowledge gleaned from basic research to develop new drugs, treatments or therapies.

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ZygoteThe single cell formed when a sperm cell fuses with an egg cell.

The rest is here:
Stem Cell Glossary

In the pantheon of weird human tumors, a teratoma has to take the cake. Typically arising from relatively unspecialized cells, these tumors are a Frankensteins monster amalgamationof tissues that can include hair, teeth and bone. They can be the butt of jokes by weary cancer biology graduate students (and even some extremely adventurous knitting projects), but in reality they are no laughing matter. In particular, they are a very real concern for scientists and physicians working to bring stem cell therapies to the clinic. In some cases, injecting stem cells into an animal or human can form, you guessed it, a teratoma.

Recently several scientificand newspaper reports have detailed the formation of tumors inso-called stem cell tourists who have traveled out of the country to receive putative stem cell therapies unapproved for use in the United States. (To learn more about this phenomena, and what experts think of it, check out my 2011article in Stanford Medicine magazine.) More recently, we reportedthat three women who participated in an unproven, experimental therapy in Florida touted as a clinical trial were blinded when stem cells from fat were injected into their eyes.

Now cardiologists Joseph Wu, MD, PhD, Patricia Nguyen, MD, and medical student Andrew Lee, PhD, have found that, at least in mice, its possible to halt or reverse the growth of human teratoma cells arising from the injection of pluripotent stem cells with radiation. This is a surprise because naturally occurring teratomas are relatively resistant to the treatment.

Theyve recently published their results in Stem Cells. I spoke to the trio to learn more about what theirresearch might mean to future human stem cell therapies.

As Nguyen explained:

As clinicians, our goal is to inject differentiated cells obtained from stem cells torepair damage, however it is very difficult to ensure a cell product that is 100 percent pure. So at very high donor cell numbers there may be residual undifferentiated cells, and thus a risk of teratoma formation. We found that, although naturally occurring teratomas are resistant to radiation treatment, those formed in laboratory mice from undifferentiated stem cells shrunk dramatically after radiation exposure. We also didnt see any significant damage to surrounding tissue.

Lee continued:

When we isolated cells from the irradiated tumors and reinjected them into mice, we found that it took far more cells three orders of magnitude greater to cause teratomas in the new animals, even though they are in the same microenvironment as they were in the original animals. This is the first time that this treatment, known as external beam radiation therapy, which is the standard-of-care for many solid tumors in humans, has been shown to be effective against tumors formed by pluripotent stem cells.

The researchers believe that the pluripotent-stem-cell-derived tumors are more sensitive to radiation than naturally occurring teratomas because they have a higher proportion of undifferentiated, rapidly dividing cells.Zapping these types of tumors with radiation could possibly be an effective way to combat those that occur in anatomically sensitive areas such as the eye, brain or spine, the researchers believe. It might circumvent the previously suggested strategy of including a genetic kill switch in the transplanted cells to be activated if tumor formation is observed. Although this approach has promise, it may be more difficult to obtain Food and Drug Administration approval for the use of these types of genetically modified cells in humans.

Wu summarized:

Weve been working with induced pluripotent stem cells for over ten years now. The primary questions have always been: A) What type of immune response might await these cells after transplantation? and B) Are these cells going to form tumors? Last year we published a report showing a combination of MRI technology and serum biomarkers offers the highest sensitivity for detecting very small stem-cell-derived teratomas in mice. Now, were learning it might be possible to slow or eradicate the growth of these tumors with the use of external beam radiation. This could be an important treatment strategy for victims of stem-cell tourism, and may reassure physicians and regulatory agencies working to bring stem cell-based therapies into the clinic.

Previously: A stem cell kill switch may make therapies safer, say Stanford researchers, A good coach and the right environment keeps stem cells in check, say Stanford researchers andOne of the most promising minds of his generation: Joseph Wu takes stem cells to heartImage by Pixabay

Go here to see the original:
Tumors caused by pluripotent stem cells can be tackled with radiation, say Stanford researchers - Scope (blog)

14 June, 2017

The ISSCR is pleased to announce Hans Clevers, Hubrecht Institute, the Netherlands, as the incoming president of the ISSCR and its board of directors. Clevers assumes the post immediately following the 15th ISSCR Annual Meeting in Boston, 14-17 June, 2017.

08 May, 2017

The ISSCR wrote to members of the Texas House of Representatives, U.S., to oppose House Bill 661, House Bill 810, and House Bill 3236, which would allow investigational agents to be sold to patients without first providing rigorous evidence of safety and efficacy. The ISSCR believes the legislation would put patients at serious risk of harm from unproven treatments.

25 April, 2017

Progress in stem cell research and its translation to the clinic will be the focus of the International Society for Stem Cell Research (ISSCR) annual meeting 14-17 June at the Boston Convention and Exhibition Center, Boston, Mass. More than 4,000 stem cell scientists, bioethicists, clinicians, and industry professionals from over 50 countries will share and discuss the latest discoveries and technologies within the field, and how they are advancing regenerative medicine.

17 March, 2017

The FY2018 Discretionary Budget Plan put forward by the U.S. Administration includes dramatic cuts in funding for science and research programs that would threaten biomedical research and its translation into new therapies for millions of people worldwide.

Link:
International Society for Stem Cell Research

Countries should unite to tackle unscrupulous advertising of unproven therapies involving stem cells, experts say.

An international group of leading experts has called for tighter regulation of so-called stem cell tourism. This involves patients travelling to other countries, where medical regulations are less strict, for treatment with potentially unsafe therapies.

Hundreds of medical centres around the world are offering therapies that involve transplantation of so-called stem cells -- which they claim have the ability to repair damaged tissues. Clinics are marketing the treatment for a range of conditions, including multiple sclerosis and Parkinson's disease.

Often these therapies are advertised directly to patients with the promise of a cure. But experts say there is often no evidence to show that the treatments will help anyone, or will not cause harm.

Researchers say the practice risks undermining the development of rigorously tested, validated therapies and puts lives at risk.

Writing in the journal Science Translational Medicine, the group has called for coordinated global action to tackle the problem.

They say tighter regulations on advertising stem cell therapies are needed, so that unsupported claims about potential clinical benefits do not go unchallenged.

Global regulatory authorities should agree international standards for the manufacture and testing of cell and tissue-based therapies, they add.

The group -- which includes experts from the University of Edinburgh -- also calls for the World Health Organization to help guide responsible clinical use of cells and tissues, as it does for medicines and medicinal devices.

Their appeal follows the deaths of two children at a clinic in Germany in 2010, which exploited a legal loophole to offer untested treatments. The clinic has since been closed.

Dr. Sarah Chan, a Chancellor's Fellow at the University of Edinburgh, said: "Many patients feel that potential cures are being held back by red tape and lengthy approval processes. Although this can be frustrating, these procedures are there to protect patients from undergoing needless treatments that could put their lives at risk.

"Stem cell therapies hold a lot of promise but we need rigorous clinical trials and regulatory processes to determine whether a proposed treatment is safe, effective and better than existing treatments."

Some types of stem cell transplantation - mainly blood and skin stem cells -- have been approved to treat certain types of cancer and to grow skin grafts for patients with severe burns. These treatments have been rigorously tested in clinical trials.

SOURCE: University of Edinburgh

Originally posted here:
Medical Tourism in Spotlight as Experts Call for Tighter Regulation - Bioscience Technology

An Edmonton professor is calling for tighter regulation of stem cell therapies, as clinics peddling expensive, unproven and dangerous treatments crop up in Edmonton and across North America.

"This is a big problem, said University of Alberta health-law professor Timothy Caulfield. Were not talking about a handful of clinics, were talking about hundreds and hundreds of clinics all over the world, including in North America.

His research has found many clinics offering the unproven therapies are charging tens of thousands of dollars per treatment, and are not advertising them as experimental.

Clinics are professing to cure conditions like Multiple Sclerosis, ALS, cancer and autism.

They represent them as if they are effective, as if they are relatively routine, and as if they are relatively risk free. And thats just not the case in the vast majority of situations, Caulfield said.

He said some advertised stem cell therapies have led to serious health problems and deaths.

Caulfield and 14 colleagues from around the world call for global regulations in a new paper in Science Translational Medicine.

Unproven stem cell therapies used to only be available through stem cell tourism for North Americans who were willing to travel abroad. But recently, theyve been popping up across North America.

Caulfield said there is one such clinic in Edmonton but did not give its name.

In many jurisdictions, he said, the clinics operate under a legal loophole.

If the treatments are considered medical practices under the domain of professional standards, rather than drugs regulated by organizations like Health Canada or the FDA, they are harder to regulate.

I call it scienceploitation. The idea is that these clinics are using the language of stem cells, an exciting and legitimate field of science, in order to sell products, Caulfield said.

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'Scienceploitation': Prof calls for crackdown on unproven stem cell ... - MetroNews Canada

By Reuters By Reuters July 8

Stem cell tourism in which patients travel to developing countries for unproven and potentially risky therapies should be more tightly regulated, according to a group of international health experts.

With hundreds of medical centers around the world claiming to be able to repair tissue damaged by conditions such as multiple sclerosis and Parkinsons disease, tackling unscrupulous advertising of such procedures is crucial.

These therapies are advertised directly to patients with the promise of a cure, but there is often little or no evidence to show they will help or that they will not cause harm, the 15 experts wrote in the journal Science Translational Medicine.

Some types of stem cell transplant mainly using blood and skin stem cells have been approved by regulators after full clinical trials found they could treat certain types of cancer and grow skin grafts for burn patients.

But many other potential therapies are only in the earliest stages of development and have not been approved by regulators.

Stem cell therapies hold a lot of promise, but we need rigorous clinical trials and regulatory processes to determine whether a proposed treatment is safe, effective and better than existing treatments, said one of the 15, Sarah Chan of Britains University of Edinburgh.

The experts called for global action, led by the World Health Organization, to introduce controls on advertising and to agree on international standards for the manufacture and testing of cell- and tissue-based therapies.

The globalization of health markets and the specific tensions surrounding stem cell research and its applications have made this a difficult challenge, they wrote. However, the stakes are too high not to take a united stance.

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'Stem-cell tourism' needs tighter controls, say medical experts - Washington Post

The World Health Minute: India's superbug problem, link found between household products and antibiotic resistance The News Minute Stem-cell tourism involving patients who travel to developing countries for treatment with unproven and potentially risky therapies should be more tightly regulated, international health experts said. With hundreds of medical centers around the world ...

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The World Health Minute: India's superbug problem, link found between household products and antibiotic resistance - The News Minute

There have been worldwide concerns surrounding stem cell therapies, where many patients are seeking unproven treatments in order to further their ongoing treatments in other countries, increasing the figures surrounding medical tourism. Sought in bone marrow and the umbilical cord, stem cells are utilised in the treatment of immune diseases, degenerative diseases and blood cancers, such as leukaemia, as well as ongoing autoimmune conditions.

However, with a growing rise of patients seeking treatments which have yet to be clinically proven, approximately 15 worldwide experts have announced a need to introduce international regulations to ban the practice for medical teams to offer treatments which are yet to be proven successful in areas such as the treatment of blood cancers, such as leukaemia.

Within the US journal Science Translational Medicine, it states: Approaches for international regulation not only need to develop consistent rules over the commercialisation of medical practices and products but also need to give them teeth by developing cross-border partnerships for compliance. However, this is made further complicated by countries not having a clear directive surrounding current regulations, besides the treatments, which are placed on different clinical frameworks.

Related Stories

The number of patient deaths in seeking unproven therapies has been on the rise in Australia and Russia, to which the health industry seeks to put a block on such ability for vulnerable patients to undertake, or become involved in unproved treatments, increasing their risks of infection and fatalities.

In the journal, it states: The term 'stem cell' has been used broadly in promises of youth, rejuvenation and good health, as well as in the branding of cosmetics, dietary supplements, and sports products. Such hyperbole carries with it not only an increased risk of exploitation of vulnerable patients and their families desperate for a cure, but also of significant damage to the health of those subjected to these unproven interventions.

Australia adopts some of the highest number of companies advertising medical treatments, without any evidence that such treatments are safe, let alone produce positive results, The Guardian reports. The Therapeutic Goods Administration is therefore seeking to fully close the regulatory loophole which enables the growth of autologous treatments, and the businesses which cater to this practice.

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The rise of medical tourism is impacting stem cell treatments ... - Healthcare Global

About Dr. Geeta Shroff and her technology

Dr. Geeta Shroff is an infertility expert located in Delhi, India, and the first individual in the world to develop an infinite number of pure human embryonic stem cell lines from using just one donated embryo. The single donated embryo originated from an IVF donor, which negates the debate over destroying numerous embryos for therapy.

Her partnering physician and anesthesiologist is Dr. Ashish Verma. The two have been working together since before the discovery of this technology in 1999. They have recently filed a patent with the World Intellectual Property Organization, covering over 126 countries including India and the United States.

Every day we hear of treatments around the world using stem cells (fetal, umbilical cord, adult, nasal, rats, etc.). Dr. Geeta Shroff has developed the only purely human embryonic stem cell lines that do not show any immune reaction in the body. Embryonic stem cells do not have any antigenic proteins on their surface and therefore do not require immunosuppressant drugs to combat rejection.

Importantly, despite the theoretical risks of human embryonic stem cells, no side effects have been reported from her therapy. Dr. Geeta Shroff practices under the guise of the Indian Health Council, which allows her to conduct clinical trials on incurable or terminal patients. She operates out of two hospitals in Delhi, India, which have ISO certifications (International Organization for Standardization) and BCI certifications (awarded by a British independent agency). Her lab is in compliance with Good Manufacturing Practice and Good Labratory Practice.

Scientific explanation of this technology

The following text was extracted from an article by Dr. Laurance Johnston Ph.D. "Embryonic Stem Cell Therapy" was published on the Healing Therapies website.

Basically, after an egg is fertilized, an embryo is formed, which then splits into a two cells. In Stem Cell Now (2006), author Christopher Scott compares the process to dividing a soap bubble with a knife, creating two smaller bubbles within the confines of the original. Cut again, and it becomes four bubbles or a four-cell embryo. This division goes on, successively creating 8, 16, 32, 64, 128-cell embryo, the total volume changing little.

Between four and six days, the cells rearrange into two layers: an outer layer that will develop into placental and amniotic tissue and a few dozen cells called the inner-cell mass (ICM) which turns into everything else. Now labeled a blastocyst, the embryo is about 0.1-mm across or the size of the period at the end of this sentence.

As the cells continue to develop, they increasingly lose their omnipotent nature. After about two weeks, the ICM starts to organize into three specific layers that become our various tissues: 1) ectodermal layer (developing into nerve, skin, etc), 2) mesodermal (turning into blood, muscle, bone, etc), and 3) endodermal (differentiating into the gut, liver, pancreas, bladder, etc.).

To obtain ESCs, the ICM cells are isolated before they start turning into these layers, and grown in culture. The culturing technology has only recently emerged and requires sophisticated methodology and skill. For example, scientists have had to grow the cells on a layer of animal cells to provide nutrients and the signals needed to keep the cells from further differentiating.

In this regard, Shroffs breakthrough is that she has grown ESCs without using any animal products, including these feeder cells. By keeping the cells purely human in nature, she makes them more amenable to transplantation. The cells from her mother culture are further adapted or primed to create daughter cultures targeting specific disorders. Hence, a more specialized cell line will be used to treat individuals with SCI, stroke, diabetes, etc.

According to Dr. Shroff, the transplanted cells will home into the tissue where they are needed, to begin regeneration. Thus, even when introduced by more remote intravenous or intramuscular routes, the cells' physiological affinity for the target tissue will cause them to migrate where they are needed.

The Potential

It can be said that the complete effect of human embryonic stem cells transplanted into a patient closely resembles the time frame of the human embryos development. This includes nine months of gestation, and then the growth of a newborn baby after delivery up until five years of age where the nervous system reaches its full potential. Although often response in patients is seen immediately after transplantation, the embryonic stem cells continue their developmental process as per their pre-programmed time frame.

This human embryonic stem cell treatment has been used in a number of conditions in clinical trials on patients from all over the world at Dr. Geeta Shroffs clinics. All have shown improvement of some kind. Some of these conditions include Diabetes, spinal cord injury, Parkinsons, Multiple Sclerosis, ALS, Chronic Lyme Disease, cerebral palsy, autism, etc. Patients with complete spinal injuries as old as 16 years are seeing dramatic results such as regaining bowel and bladder control and function in their legs; Diabetics are weaning off their insulin or have been able to withdraw from medication completely; and neurodegenerative disease patients with brain lesions are seeing reversals.

*Some of this information has been used with permission from Amanda Boxtel's blog, Awakenings.

To read more....

Here's a Global Post Article on Dr. Shroff and Amy's treatment.

For related information, please read Stem Cell Cheat Sheet.

For an interview with Dr. Ashish from the clinic, read Stem Cell Curiosity: Answers From India.

Amy answers frequently asked questions about her India treatment.

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Dr. Geeta Shroff's Stem Cell Technology | Healthcare Hacks

The increasing trend of smoking and air pollution has affected human health badly; more and more people are succumbing to diseases of airways and lungs. Air pollution and smoking are commonly present in every country especially in industrialized centers. Significant numbers of people complaining of chronic cough, breathlessness and repeated chest infections are diagnosed having airway or lung disease. When we go behind the causes of such complaints, bronchial asthma and chronic obstructive pulmonary disease come on the top. COPD is especially dangerous because it gradually causes lung damage and results in respiratory failure and heat failure.

Chronic Obstructive Pulmonary Disease is actually a disease of lung as well as airways. It is caused by chronic irritation of airways (by smoking, dust, air pollution) that sets an inflammatory response resulting in narrowing of airways and damage to the lungs. The suffers complain of cough with sputum, shortness of breath, wheezing and in advance stages body swelling due to heart failure. It is a terrifying fact that around 200 million people worldwide are suffering from chronic obstructive pulmonary disease or COPD and approximately 3 million deaths annually are attributed to this deadly disease. With so much disease burden worldwide, COPD stands among the major health problems. The question arises is there some curative treatment for COPD or not?

Previously available treatments for COPD have their only limitations and complications; they dont have curative potential rather they only improve the situation for some times. Conventional medical therapy is not effective at restoring lung function while on the other hand heart lung transplantation (an option for patients which advanced COPD and respiratory failure/heart failure) is not available to each patient due to higher cost, higher mortality and limited number of donors. This necessitates an innovative treatment of COPD; a treatment which is both curative and safely available to every patient. Such a treatment for COPD is stem cell therapy.

Stem cell therapy stands high on the list as a definite and curative treatment with potential availability for almost every person. It has passed through stages of animal experimentation and clinical trials on humans to be declared a safe treatment for chronic obstructive pulmonary disorder (COPD), emphysema, chronic bronchitis, pulmonary fibrosis and interstitial lung disease. Many countries of the world have tested stem cell therapy for cure or remission of COPD patients.

Stem cells, as we know, have the potential to differentiate into different types of cells including cells present in the lungs. When we inject stem cells in a patient with COPD and administer some specific type of factors that help cell differentiation and growth, they reach at the site of damaged cells and replace them. Stem cells take the function of damaged cells and help in healing the injury and setting off the fire of destruction. Lung function is improved gradually after stem cell transplantation and patient gets his complaints allayed in matter of months. Stem cell therapy has several advantages over heart/lung transplant and these include:

Mexico Stem Cell Therapy is among the top rated places in the world for stem cell transplantation. Our hospitals especially are registered for this purpose and comply with the guidelines of safety and standard. Latest technology and experienced stem cell physicians make the therapy happen in a very pleasant and successful environment. Patients around the world enjoy these facilities and a high standard of care.

We offer stem cell therapy for a number of diseases including lung-related diseases, such as COPD, pulmonary fibrosis, chronic bronchitis, emphysema and interstitial lung disease.

The best regenerative medicine option will be based on your medical history and health condition. Remember, the sooner you get treatment the better the results.

If you would like to find out more about treatment options, contact our patient coordinators today at (855) 768-7247. We work with you and your pulmonologist to improve your condition.

Updated Dec 29, 2015

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Stem Cell Therapy for COPD | Mexico Stem Cell Therapy

The phrase stem-cell tourism often conjures images of back-alley clinics in distant lands, destinations such as Mexico and China, to which, increasingly, desperate patients are travelling to undergo risky and unproven treatments.

But according to new research, another country is being overlooked in the debate over stem-cell tourism: the United States.

In a study published Thursday by the journal Cell Stem Cell, researchers analyzed the Internet to find that there are 351 businesses in the United States, collectively operating at least 570 stem-cell clinics.

The clinics advertise treatments that involve injecting primitive, undeveloped cells into patients bodies. They also claim to treat a laundry list of problems, from autism and Alzheimers disease to sexual dysfunction, even though clinical trials have not proven that stem-cell treatments are safe or effective for any of these.

But, if the size of the marketplace is any indication, American stem-cell clinics are doing booming business, even attracting patients from Canada, and charging thousands or tens of thousands for their services.

Experts agree that the science is at a tipping point, but it moves slowly and stem-cell therapies arent ready yet for prime time, according to Timothy Caulfield, a University of Alberta professor and Canada research chair in health policy and law.

Caulfield warns that the list of diseases with proven stem-cell treatments is still incredibly short.

Regulators in Canada and the U.S. have, for the most part, approved things such as skin grafts or bone marrow transplants for blood cancers such as leukemia.

These clinics are really leveraging the excitement around the field, Caulfield said. People think there are all these efficacious stem-cell therapies that are available now, and thats really not the case.

In the study, researchers found that stem cell clinics in the U.S. are clustering in certain cities, such as Beverly Hills and New York, and states such as California and Florida

Most advertise autologous stem cells, cells mined from the patients body, typically fat tissue. An estimated one in five clinics claim to use stem cells sourced from amniotic material, placental tissue or umbilical cords. And at least two clinics advertised using bovine amniotic cells.

But because these clinics are not regulated, patients have no way of knowing what they are being injected with, said study co-author Leigh Turner, a bioethicist with the University of Minnesota.

Maybe patients are paying $15,000 for whats effectively a blood transfusion.

He noted that many businesses also advertise the same stem-cell procedure for treating a wide range of highly complex disorders, something that should serve as a warning sign.

Turner believes his study highlights an urgent need for federal regulators to crack down on stem-cell clinics, closing regulatory loopholes that have allowed them to thrive.

Its difficult to see how these could possibly be compliant with federal regulations, Turner said. What we have is rampant marketing of unproven, unapproved stem-cell interventions, all of it happening in the U.S., all of it happening beneath the nose of the FDA.

A main concern, of course, is that these treatments come with unknown risks.

Study co-author Paul Knoepfler points out scientists still dont understand the harms that could arise from stem-cell injections, both short and long term.

Maybe theres a moderate risk, but it doesnt manifest until 10 to 20 years later, he said.

Some of these risks, such as blood clots, have been documented by the scientific literature.

There have been high profile disasters: patients in Florida and Europe who have died after stem-cell treatments, or a California woman who developed bone fragments in her eyelids after undergoing a stem-cell facelift.

One woman who participated in a clinical trial in Portugal developed a growth in her spine, a growth that had nasal tissue and bits of bone in it.

The New York Times recently reported the horrifying story of a stroke victim who spent $300,000 on stem-cell injections, only to develop a huge mass in his spinal column, which has left him paralyzed from the neck down.

His doctors have no idea how to stop the mass from growing.

You can get the wrong type of tissue growing in the wrong place, said Knoepfler, a professor with the University of California, Davis.

And, if a stem-cell transplant goes wrong, thats a living thing, you know?

There might not be a way to undo that.

Stem-cell tourism is largely driven by patients who describe seemingly miraculous cures. These people can be celebrities such as Gordie Howe, who lend their star power to the stem-cell industry, or ordinary patients such as Tina Kapel, a 49-year-old woman from Stouffville, Ont., who has Parkinsons disease.

Kapel said she has refused the drugs recommended by doctors because she distrusts pharmaceutical companies and doesnt like the side effects. Instead, she has turned to a Paleo diet, acupuncture and naturopathy.

Last year, she stumbled on stem-cell treatments after Googling terms such as reversing Parkinsons and natural cures. At the urging of her naturopath, she flew to California for a stem-cell procedure.

The procedure cost $14,995 U.S., which she paid using lines of credit and loans from friends and family. She is unable to work because of her Parkinsons and finds herself in a horrible position financially, but says she would do it all over again.

Im better than I was before the transplant, she says, adding she hopes to get another treatment, and is now trying to raise money online for more injections. When you live in a Parkinsons body, the reality is Im willing to take the chance.

Knoepfler and Turner hear from patients all the time. But they said that, without good clinical trials for treatments, its impossible to know whats really going on with them. Is there something else the patient is doing that might account for the improvements? Could they be experiencing a placebo effect, an undeniably powerful force, especially when patients are desperate and have invested tens of thousands of dollars?

Or perhaps the treatments do work. The only way to know for certain is through research, not relying on anecdotes, Caulfield said.

For now, stem-cell clinics and their claims should be treated with extreme caution, he said.

If it was that easy to translate this stuff into treatments, that would be happening; the best scientists in the world are working on it, Caulfield said.

We all want it to work . . . if only it was that easy.

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U.S. overlooked in debate over stem-cell tourism ...

En Espaol

International stem cell clinics advertise curesfor a price. Understand the concerns over stem cell tourism and what CIRM is doing to bring real cures to patients who need them.

International (and even domestic) clinics have begun advertising unproven therapies at great cost to the patient and at great profit to the clinicthis is whats referred to as stem cell tourism. But a closer look will often reveal no information about what type of stem cells are being offered. These sites also rely heavily on video testimonials from people soon after the stem cell injections, but little information about how those people fared long-term.

At the 2010, meeting of the International Society for Stem Cell Research in San Francisco, CIRM co-hosted a panel in which the worlds top experts discussed the steps leading to a stem cell therapy, and concerns about stem cell tourism.

At that panel, the ISSCR previewed their new web site designed to help patients and their families assess international clinics advertising stem cell cures.

CIRM is also one of 13 organizations who issued a joint advisory on stem cell tourism, which addresses questions about how to identify regulated stem cell clinical trials. You can read that advisory here.

Find out More: A Dose of Reality on Alternative Stem Cell Treatments (video) ISSCR: A closer look at stem cell treatments The Power of Stem Cells

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Stem Cell Tourism | California's Stem Cell Agency

Every day we get a call from someone seeking help. Some are battling a life-threatening or life-changing disease. Others call on behalf of a friend or loved one. All are looking for the same thing; a treatment, better still a cure, to ease their suffering.

Almost every day we have to tell them the same thing; that the science is advancing but its not there yet. You can almost feel the disappointment, the sense of despair, on the other end of the line.

If its hard for us to share that news, imagine how much harder it is for them to hear it. Usually by the time they call us they have exhausted all the conventional therapies. In some cases they are not just running out of options, they are also running out of time.

Chasing hope

Sometimes people mention that they went to the website of a clinic that was offering treatments for their condition, claiming they had successfully treated people with that disease or disorder. This week I had three people mention the same clinic, here in the US, that was offering them treatments for multiple sclerosis, traumatic brain injury and chronic obstructive pulmonary disease (COPD). Three very different problems, but the same approach was used for each one.

Its easy to see why people would be persuaded that clinics like this could help them. Their websites are slick and well produced. They promise to take excellent care of patients, often helping take care of travel plans and accommodation.

Theres just one problem. They never offer any scientific evidence on their website that the treatments they offer work. They have testimonials, quotes from happy, satisfied patients, but no clinical studies, no results from FDA-approved clinical trials. In fact, if you explore their sites youll usually find an FAQ section that says something to the effect of they are not offering stem cell therapy as a cure for any condition, disease, or injury. No statements or implied treatments on this website have been evaluated or approved by the FDA. This website contains no medical advice.

What a damning but revealing phrase that is.

Now, it may be that the therapies they are offering wont physically endanger patients though without a clinical trial its impossible to know that but they can harm in other ways. Financially it can make a huge dent in someones wallet with many treatments costing $10,000 or more. And there is also the emotional impact of giving someone false hope, knowing that there was little, if any, chance the treatment would work.

Shining a light in shady areas

U.C. Davis stem cell researcher, CIRM grantee, and avid blogger Paul Knoepfler, highlighted this in a recent post for his blog The Niche when he wrote:

Paul Knoepfler

Patients are increasingly being used as guinea pigs in the stem cell for-profit clinic world via what I call stem cell shot-in-the-dark procedures. The clinics have no logical basis for claiming that these treatments work and are safe.

As the number of stem cell clinics continues to grow in the US and morephysicians add on unproven stem cell injections into their practices as a la carte options, far more patients are being subjected to risky, even reckless physician conduct.

As if to prove how real the problem is, within hours of posting that blog Paul posted another one, this time highlighting how the FDA had sent a Warning Letter to the Irvine Stem Cell Treatment Center saying it had serious concerns about the way it operates and the treatments it offers.

Paul has written about these practices many times in the past, sometimes incurring the wrath of the clinic owners (and very pointed letters from their lawyers). Its to his credit that he refuses to be intimidated and keeps highlighting the potential risks that unapproved therapies pose to patients.

Making progress

As stem cell science advances we are now able to tell some patients that yes, there are promising therapies, based on good scientific research, that are being tested in clinical trials.

There are not as many as we would like and none have yet been approved by the FDA for wider use. But those will come in time.

For now we have to continue to work hard to raise awareness about the need for solid scientific evidence before more people risk undergoing an unproven stem cell therapy.

And we have to continue taking calls from people desperate for help, and tell them they have to be patient, just a little longer.

***

If you are considering a stem cell treatment, the International Society for Stem Cell Research had a terrific online resource, A Closer Look at Stem Cells. In particular, check out the Nine Things to Know about Stem Cell Treatments page.

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Guest Author Geoff Lomax is CIRMs Senior Officer for Medical and Ethical Standards.

In the spirit of Stem Cell Awareness Day, Cell Stem Cell has compiled a Public Interest collection of articles covering ethical, legal, and social implications of stem cell research and made it freely available. The collection may be found here.

The collection covers issues ranging from research involving human embryos to the use of stem cell therapies in patients. For those of you interested in a good primer on the history of stem cell controversies, Herbert Gottweis provides a detailed review of the federal policy debate in the United States. This debate has resulted in inconsistent policy and disrupted research. Gottweis uses this history to support his message that a comprehensive, and proactive policy approach in this field beyond the quick legal fix is needed for patients to ultimately benefit from the science.

What I found most interesting about this collection was the focus on stem cell treatments and tourism. A majority of the articles address the use of stem cells in patients. This focus is an indicator of how far the field has progressed. Stem cells clinical trials are now a reality and this results in two separated but related considerations. First, is how to make sure prospective patients are well informed should they participate in a clinical trial. Second, how to avoid stem cell snake oil where someone is pitching an unproven procedure. These issues are related by their solution that involves empowerment and education of patients and their support networks.

For example, in Stem Cell Tourism and Public Education: The Missing Elements, Master writes:

It is important for the scientific, medical, ethics, and policy communities to continue to promote accurate patient and public information on stem cell research and tourism and to ensure that it is effectively disseminated to patients by working alongside patient advocacy groups.

Masters team found that groups committed to the advancement of good science, including patient advocates and researchers, often lacked basic information about clinical trials and other options for patients. This lack of information may contribute to patients being wooed by those pitching unproven procedures. Thus, the research community should continue to work with patients and advocacy organizations to identity options for treatment.

Another aspect of patient empowerment is what Insoo Huyn refers to as therapeutic hope in his piece: Therapeutic Hope, Spiritual Distress, and the Problem of Stem Cell Tourism. Huyn suggests that a supportive system for delivering cell therapies should includes nurturing hope. He writes, patients might understand when an interventions chances of success are extremely remote at best, but may still want to give it a shot as long as a beneficial outcome cannot be ruled out as categorically impossible. Huyn recognizes that well developed early-stage clinical trials are not expected to provide a benefit to patients (they are designed to evaluate safety), but the nature of the therapeutic (often cells) means there may be some real effect.

A third piece by the ISSCR Ethics Taskforce titled Patients Beware: Commercialized Stem Cell Treatments on the Web presents a guide to evaluating therapies. They present five principles that patients, researchers and advocates can rally around to identify credible interventions. The taskforce states:

The guiding principles for the development of the recommended process were that (1) the standards for identifying and reviewing clinics and suppliers should be objective and clear; (2) the inquiry and review process should be publicly transparent and relatively straight- forward for any clinic or practitioner to comply with; (3) conflicts of interest, if any, of the declarant ought to be disclosed to the ISSCR; (4) there should be no actual or apparent conflicts of interest of staff or others involved in the inquiry or review process for any particular matter; and (5) any findings that a clinic fails to meet standards should be communicated in a specific factual way, rather than with broad conclusions of fraudulent practices.

While the Cell Stem Cell Public Interest series covers a range of issues related to stem cells and society, the emphasis on treatments and patients is a reminder of how far the field has come. There is broad consensus that patients, researchers and advocates have roles to play in advancing safe and effective cell therapies.

Geoff Lomax

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Here are some stem cell stories that caught our eye this past week. Some are groundbreaking science, others are of personal interest to us, and still others are just fun.

The zebrafish (Danio rerio) owes its name to a repeating pattern of blue stripes alternating with golden stripes. [Credit: MPI f. Developmental Biology/ P. Malhawar]

How the Zebrafish Got its Stripes. Scientists in Germany have identified the different pigment cells that emerge during embryonic development and that determine the signature-striped pattern on the skins of zebrafishone of sciences most commonly studied model organisms. These results, published this week in the journal Science, will help researchers understand how patterns, from stripes to spots to everything in between, develop.

In the study, scientists at the Max Planck Institute for Developmental Biology mapped how three distinct pigment cells, called black cells, reflective silvery cells, and yellow cells emerge during development and arrange themselves into the characteristic stripes. While researchers knew these three cell types were involved in stripe formation, what they discovered here was that these cells form when the zebrafish is a mere embryo.

We were surprised to observe such cell behaviors, as these were totally unexpected from what we knew about color pattern formation, says Prateek Mahalwar, first author of the study, in a news release.

What most surprised the research team, according to the news release, was that the three cell types each travel across the embryo to form the skin from a different direction. According to Dr. Christiane Nsslein-Volhard, the studys senior author:

These findings inform our way of thinking about color pattern formation in other fish, but also in animals which are not accessible to direct observation during development such as peacocks, tigers and zebras.

Sound Waves Dispense Individual Stem Cells. It happens all the time in the lab: scientists need to isolate and study a single stem cell. The trick is, how best to do it. Many methods have been developed to achieve this goal, but now scientists at the Regenerative Medicine Institute (REMEDI) at NUI Galway and Irish start-up Poly-Pico Technologies Ltd. have pioneered the idea of using sound waves to isolate living stem cells, in this case from bone marrow, with what they call the Poly-Pico micro-drop dispensing device.

Poly-Pico Technologies Ltd., a start-up that was spun out from the University of Limerick in Ireland, has developed a device that uses sound energy to accurately dispense protein, antibodies and DNA at very low volumes. In this study, REMEDI scientists harnessed this same technology to dispense stem cells.

These results, while preliminary, could help improve our understanding of stem cell biology, as well as a number of additional applications. As Poly-Pico CEO Alan Crean commented in a news release:

We are delighted to see this new technology opportunity emerge at the interface between biology and engineering. There are other exciting applications of Poly-Picos unique technology in, for example, drug screening and DNA amplification. Our objective here is to make our technology available to companies, and researchers, and add value to what they are doing. This is one example of such a success.

The Dangers of Stem Cell Toursim. Finally, a story from ABC News Australia, in which they recount a womans terrifying encounter with an unproven stem cell technique.

In this story, Annie Levington, who has suffered from multiple scleoris (MS) since 2007, tells of her journey from Melbourne to Germany. She describes a frightening experience in which she paid $15,000 to have a stem cell transplant. But when she returned home to Australia, she saw no improvement in her MSa neuroinflammatory disease that causes nerve cells to whither.

They said I would feel the effects within the next three weeks to a year. And nothing I had noticed nothing whatsoever. [My neurologist] sent me to a hematologist who checked my bloods and concluded there was no evidence whatsoever that I received a stem cell transplant.

Sadly, Levingtons story is not unusual, though it is not as dreadful as other instances, in which patients have traveled thousands of miles to have treatments that not only dont cure they conditionthey actually cause deadly harm.

The reason that these unproven techniques are even being administered is based on a medical loophole that allows doctors to treat patients, both in Australia and overseas, with their own stem cellseven if that treatment is unsafe or unproven.

And while there have been some extreme cases of death or severe injury because of these treatments, experts warn that the most likely outcome of these untested treatments is similar to Levingtonsyour health wont improve, but your bank account will have dwindled.

Want to learn more about the dangers of stem cell tourism? Check out our Stem Cell Tourism Fact Sheet.

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One of the big concerns among scientists including many at the International Society for Stem Cell Research (ISSCR) conference in Vancouver, Canada is that patient expectations about stem cells are often greater than researchers are able to deliver today. That can result in patients in search of a cure heading to overseas clinics that offer unproven therapies.

Megan Munsie head of the Education, Ethics, Law and Community Awareness Unit at the University of Melbourne in Australia wanted to find out what happens when patients hopes for new treatments come into conflict with scientific views on medical evidence. So she started with a small survey of 16 Australians, patients and patient-caretakers, who had travelled outside Australia for stem cell treatments for a variety of diseases including MS and cerebral palsy.

She says there were a number of interesting findings:

Perhaps the most surprising finding was that all of them talked about the benefits they gained from going abroad for the treatment, that it gave them a sense of hope even if there was no evidence of medical benefit.

What happens when patients hopes for new treatments come into conflict with scientific views on medical evidence?

This led to a bigger study where Munsie surveyed patients and patient advocates but also stem cell scientists and physicians. Not surprisingly the researchers had a very different view of the subject than the patients.

Researchers/doctors said they felt that patients dont understand science and dont appreciate the subtleties of clinical trials

What was interesting, however, is that many doctors said they didnt try to persuade their patients not to go, instead they chose to respect their autonomy but did at least try to give them the facts so that they could make a decision based on knowledge not ignorance.

When asked why they didnt tell patients not to go, they said they respected the patients need for hope and didnt want to take that away from them because they had nothing they could offer to replace it.

Munsie says recently some doctors have started offering these kinds of unproven therapies in Australia. She talked to four of them asking how they could justify it. All four said there is a huge unmet medical need and it was better to offer these therapies in Australia than have patients travel to other countries for them. They also said that they felt competent to provide treatment because they had undergone some kind of training or had a license to use equipment needed for the therapy.

Ironically while they all considered themselves legitimate providers of a needed medical therapy albeit an unproven one and only interested in the science, they regarded others doing the same as cowboys and only interested in the money.

When asked if they would support more regulation of the kinds of therapies they were already offering they said yes, saying that the other doctors who claimed they were self-regulating is like giving the keys to the asylum to the lunatics.

Munsie says its clear that its not just patients who could benefit from some guidance on expectations about stem cell therapies.

She says we need to do a better job of managing patient expectations without robbing them of a sense of hope, perhaps by offering them information that is more tailored to their particular needs.

We also need to manage what she called the unbridled enthusiasm of providers who are offering speculative treatments as medical practice. That might take regulatory change by the government.

She says its difficult to strike a balance between hope and scientific evidence, in maintaining a patients sense of optimism while acknowledging the reality of the science and the risks posed by unproven treatments.

Kevin McCormack

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One of the big concerns among scientists including many at the International Society for Stem Cell Research (ISSCR) conference in Vancouver, Canada is that patient expectations about stem cells are often greater than researchers are able to deliver today. That can result in patients in search of a cure heading to overseas clinics that offer unproven therapies.

Megan Munsie head of the Education, Ethics, Law and Community Awareness Unit at the University of Melbourne in Australia wanted to find out what happens when patients hopes for new treatments come into conflict with scientific views on medical evidence. So she started with a small survey of 16 Australians, patients and patient-caretakers, who had travelled outside Australia for stem cell treatments for a variety of diseases including MS and cerebral palsy.

She says there were a number of interesting findings:

Perhaps the most surprising finding was that all of them talked about the benefits they gained from going abroad for the treatment, that it gave them a sense of hope even if there was no evidence of medical benefit.

What happens when patients hopes for new treatments come into conflict with scientific views on medical evidence?

This led to a bigger study where Munsie surveyed patients and patient advocates but also stem cell scientists and physicians. Not surprisingly the researchers had a very different view of the subject than the patients.

Researchers/doctors said they felt that patients dont understand science and dont appreciate the subtleties of clinical trials

What was interesting, however, is that many doctors said they didnt try to persuade their patients not to go, instead they chose to respect their autonomy but did at least try to give them the facts so that they could make a decision based on knowledge not ignorance.

When asked why they didnt tell patients not to go, they said they respected the patients need for hope and didnt want to take that away from them because they had nothing they could offer to replace it.

Munsie says recently some doctors have started offering these kinds of unproven therapies in Australia. She talked to four of them asking how they could justify it. All four said there is a huge unmet medical need and it was better to offer these therapies in Australia than have patients travel to other countries for them. They also said that they felt competent to provide treatment because they had undergone some kind of training or had a license to use equipment needed for the therapy.

Ironically while they all considered themselves legitimate providers of a needed medical therapy albeit an unproven one and only interested in the science, they regarded others doing the same as cowboys and only interested in the money.

When asked if they would support more regulation of the kinds of therapies they were already offering they said yes, saying that the other doctors who claimed they were self-regulating is like giving the keys to the asylum to the lunatics.

Munsie says its clear that its not just patients who could benefit from some guidance on expectations about stem cell therapies.

She says we need to do a better job of managing patient expectations without robbing them of a sense of hope, perhaps by offering them information that is more tailored to their particular needs.

We also need to manage what she called the unbridled enthusiasm of providers who are offering speculative treatments as medical practice. That might take regulatory change by the government.

She says its difficult to strike a balance between hope and scientific evidence, in maintaining a patients sense of optimism while acknowledging the reality of the science and the risks posed by unproven treatments.

Kevin McCormack

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Patients falling prey to stem cell tourism may pay tens of thousands of dollars for procedures that carry no promise of success or carry grievous risks of failure, says law and bioethics Professor Alta Charo.

Photo illustration: iStock

Desperate patients are easy prey for unscrupulous clinics offering untested and risky stem cell treatments, says UWMadison law and bioethics Professor Alta Charo, who is studying stem cell tourism.

Stem cells are cells that can form many types of cells in the body, and that makes them inherently promising and dangerous. Stem cell tourism refers to people traveling, both within the U.S. and abroad, in pursuit of advertised stem cell therapies to purportedly treat a variety of medical conditions.

Alta Charo

The evidence for therapeutic use of stem cells is very limited, except for bone marrow stem cells, but patients all over the world are convinced stem cells will cure their disease, says Charo. While there are some very promising results in the early clinical trials for stem cell therapies using embryonic and other kinds of stem cells, the treatments being advertised by these clinics are dubious, mostly ineffective, and sometimes positively harmful.

Patients are being hoodwinked, but there are dilemmas about tackling (the treatments) at regulatory or political levels.

The outrage over failures in stem cell tourism is limited, Charo says. Patients may pay tens of thousands of dollars for procedures that may carry no promise of success or carry grievous risks of failure. Most people have no reason to pay attention, and those who are paying attention are sick, so they are focused on trying anything, Charo says. If it does not work, they are already in a bad position with plenty to think about.

During a search for stem cell therapies on the web, Charo found products that supposedly enhance the natural formation of stem cells in the skin alongside approved and unapproved treatments in the United States, and stem cell clinics outside the United States, like a stem cell treatment for spinal conditions that might be innocuous, but is probably useless.

While there are some very promising results the treatments being advertised by these clinics are dubious, mostly ineffective, and sometimes positively harmful.

Alta Charo

Some American operators are trying to slip through Food and Drug Administration regulation, says Charo, who served as senior policy advisor in the Office of the Commissioner of the FDA between 2009 and 2011. The FDA regulates medical devices, tissue transplants and drugs, but not organ transplants or the way medicine is practiced.

To sell a product that can heal without claiming it is a drug, some clinics remove stem cells from a patient, grow them with minimal manipulation, and then reinsert the resulting cells back to the same patient. There has been a long-running battle over whether that is a tissue transplant akin to organ transplantation and thus the practice of medicine, or a tissue transplant that is acting like drug, Charo says. If the latter, then what you do is subject to FDA (regulation), so you have to prove that your product is safe and effective, which almost always requires expensive clinical trials.

In early February, an appeals court upheld the FDAs ability to regulate manipulated stem cells as drugs, Charo notes. But the victory may be hollow: Each case takes a tremendous amount of effort to bring suit, prove the facts and win the appeal, and many other clinics may open up in the meantime.

In some countries, pretty much anything goes, Charo says. Almost half of stem cell treatments occur in China, but Mexico and Russia also have growing sectors. Some clinics advertise brain injury treatment for patients who are in no condition to travel, she says. Patients, and especially parents of children with injury or disease, are often desperate. One child went to Russia and raw bone marrow was injected into the brain. Its horrifying.

One child went to Russia and raw bone marrow was injected into the brain. Its horrifying.

Alta Charo

One view of stem cell tourism comes from studies by Paul Knoepfler of the University of California, who found that most clinical trials occur in Europe and especially the United States, where regulation is strictest, but the so-called therapeutic clinic locations are mostly in China, Mexico and Costa Rica, Charo says. She also cites research by Timothy Caulfield of the University of Alberta and Allen Petersen at Monash University in Australia, who are studying the motivations and effect of stem cell tourism.

Its unclear how much harm these unregulated treatments are causing to medical tourists because in the absence of comprehensive regulation, there is no comprehensive follow-up data. We already have had two reported deaths of children, and there are probably more people injured than anybody would imagine. Its time we started complaining a little more loudly, Charo says.

Limits on advertising could slow medical tourism to unscrupulous clinics, but that tactic is legally troublesome, Charo says. The International Society for Stem Cell Research tried to list effective and ineffective clinics, but it got letters charging it with business defamation. Even if they could have won they did not have money for the litigation, so they took down the posting. It was tremendously frustrating.

It is time to lose the hype without losing the hope.

Alta Charo

Consumers, she says, could raise these issues with the Federal Trade Commission, which is charged with regulating false or misleading advertising, but gets few complaints on the issue. Scientists can work with fellow scientists, with patient-advocacy organizations and regulatory authorities such as the FDA.

At this point, Charo notes, stem cells have become a magic word. Often new areas of science get that reputation; in 19th century medical devices, everything with electricity or magnetism was magic. Today its stem cells and nanotechnology. It is time to lose the hype without losing the hope.

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Home Blogs Stem Cell Treatment Mexico Stem Cell Therapy in Mexico for Chronic Heart Failure

Stem cell therapy in Mexico for chronic heart failure can help reduce the risk of heart attack at an affordable price. Though heart stem cell treatment in Mexico is yet to find many takers, patients will be glad to know that the Latin American country is home to numerous state-of-the art hospitals offering stem cell therapy.

Medical tourism in Mexicois a growing industry and one can undergo quality, yet affordable treatments in the country.

The study showed that patients with low-functioning hearts could improve their condition with the help of ACP stem cell therapy, which is also available in Mexico.

Management of congestive heart failure in Mexico is a good alternative to undergoing treatment in the developed countries of the world. Some of the reasons why patients choose stem cell therapy for chronic heart failure in Mexico are as follows:

Stem cell therapy in Mexico for chronic heart failure can be a low cost solution to leading a healthier life. And if you are an American or a Canadian, all you need to do is a bit of traveling for getting treated at a state-of-the-art facility.

Submit the free quote request form on the right for more information.

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Stem Cell Therapy in Mexico for Chronic Heart Failure ...