Are Stem Cell Companies Abusing ClinicalTrials.gov? – PLoS Blogs (blog)

Im often asked about the safety of treatments that purport to inject stem cells into painful body parts. The reputation of stem cells seems to exceed the reach, with companies touting treatments that arent FDA approved or even being tested.

Back in March, an alarming article in the New England Journal of Medicinedescribed three women blinded by stem cell treatments two of the patients reported seeing a reference on the company website to registration at the National Institutes of Healths well-respected ClinicalTrials.gov, and assuming it applied to their treatment. It didnt.

In what is perhaps a modern version of hawking snake oil, companies can indeed register certain clinical trials without breaking any rules but desperate patients might not know that.

There is no doubt that some patients have misinterpreted a studys listing on ClinicalTrials.gov as a stamp of legitimacy, federal review, and compliance. In this way, treatments with no safety or efficacy data, no prior clinical study, and no ongoing clinical trials under FDA review, appear to have federal approval. Such a misunderstanding can lead to disastrous outcomes for patients, said Thomas Albini, MD, of the Bascom Palmer Eye Institute of the University of Miami, who treated the blinded women.

When I wrote about the disaster here at DNA Scienceand atMedscape Medical News, my Medscape editor asked me to take a closer look at criteria for listing investigations at ClinicalTrials.gov. It proved an interesting exercise, but I declined to write an article, fearing lawsuits if I named companies.

ClinicalTrials.gov is where research groups, in academia and pharma/biotech, describe protocols to evaluate the safety and efficacy of new drugs, biologics, and devices, which FDA regulates, typically in randomized, controlled trials. But for an observational study that just follows what happens after a treatment, no such thumbs-up is required; no investigational new drug (IND) designation or investigational device exemption (IDE) need be filed. And that creates a loophole that companies are happily jumping through and luring patients in pain, who may know little about clinical trial design, and perhaps trust too much the companies and the doctors offering these services.

Its easy to see how people are fooled. One company claims that By providing access to registered clinical studies through the NIH, we are providing patients with the ability to choose a stem cell treatment center with the highest standard of care. If the treatment is experimental, how can there even be a standard of care?

MOST STUDIES LEGIT

I love ClinicalTrials.gov its packed with information about all manner of conditions, with contacts and references. I started my investigation by searching for studies that sounded bogus.

I began with a treatment that epitomizes pseudoscience: magnets. But I was fooled. Other than legit uses in medical devices, my magnet search called up as an acronym of sorts for theMothers and Girls Dancing Together Trial, a well-designed study on preventing childhood obesity, with a decent sample size and controls.

I also thought the randomised crossover trial of the acute effects of a deep-fried Mars bar or porridge on the cerebral vasculature was fake, but it turned out to be a medical students project, well done, and published in the Scottish Medical Journal.

But trial NCT02833532, sponsored by a Korean pharmaceutical company, was likely a joke, with the stated purpose of temporary penile enhancement and one of the investigators first name being Dong. Participants must answer the question How do you rate your penile size? Very small/small/normal/big/very big to enroll. Those accepted get to try something made of hyaluronic acid, which is found, coincidentally, in cocks combs.

Searching ClinicalTrials.gov for stem cells returns more than 4,000 entries, so I gave up. Fortunately, Leigh Turner, PhD, associate professor at the Center for Bioethics at the University of Minnesota, wasnt afraid of lawyers and took a more measured, scholarly approach. He recently published the intriguing findings in Regenerative Medicine, where you can find nice tables naming the stem cell companies that use and possibly abuse ClinicalTrials.gov.

AN ACADEMIC INVESTIGATION

Dr. Turner searched ClinicalTrials.gov for stem cells along with patient-sponsored, patient-funded, and self-funded because expecting patients to pay is a red flag. Only a very few real clinical trials charge patients, and those that do must have FDA approval to do so.

He found 7 such pay-as-you-go clinical trials, each enrolling more than 100 people, at the government website, and another 11 in a database of companies that provide direct-to-consumer stem-cell-based treatments. The DTC label indicates that the treatments arent part of a real experimental protocol. One of themhad signed up more than 3,000 gullible people.

The companies that charge patients yet proclaim a ClinicalTrials.gov listing are having their proverbial cake and eating it too borrowing the governmental veneer of a sanctioned clinical trial, while collecting fees. And many health care consumers arent even aware theyre being bamboozled.

Another red flag in a stem cell pitch is an everything-but-the-kitchen-sink list of targets. Stem Cell Network, for example, claims to be able to treat, using stem cells grown from a patients fat, some 28 conditions, including the vague knee problems, and also muscular dystrophy, ankle problems, neuropathy, asthma, and alopecia areata. Also be wary of stem cells derived from one body part like butt fat being injected into another body part such as eyeballs.

Wed like people to protect themselves by going to a reliable website, like ClinicalTrials.gov, to distinguish legitimate from bogus claims of stem cell clinics. But the findings of this paper challenge that advice because this valuable resource, which is designed to promote transparency and to help people find clinical trials, lists unlicensed and unproven stem cell interventions that companies turn into personal marketing platforms. So if you have ALS, MS, Parkinsons disease, a ClinicalTrials.gov listing looks like any other study on the NIH website. Many people think a listing is credible, Dr. Turner told me.

There is an urgent need for careful screening of clinical studies before they are registered with ClinicalTrials.gov, Dr. Turners paper concludes. But in the current climate of a nuclear threat, a health care system in disarray, and possible cuts to the CDC, FDA, and NIH, ramping up scrutiny at ClinicalTrials.gov is unlikely to have priority, if the President even has a clue what it is.

Its not possible to slash, burn, defund, and deregulate at every turn and think that federal agencies are going to improve how they function. But no administration is forever, no budget is forever, deregulatory moments dont last forever, and perhaps problems that are ignored or neglected now will be addressed in the future, with collateral damage along the way while nothing is done, warns Dr. Turner, who lives in Canada. I wonder if he has a spare room.

Those seeking stem cell treatments should check out the International Society for Stem Cell Research (ISSCR) Patient Handbook on Stem Cell Therapiesand stemcells.nih.gov. Alas, much of the media is still somewhat unfamiliar with the biology of stem cells, that they are not cells that can turn into any cell typebut that they self-renew and jettison a new stem cell at every division. Thats what makes them stem cells, not the ability to spawn specialized cells.

So I tell people who ask me if they should have stem cells shot into their aching knees or backs to do so only if they wouldnt object to an abnormal growth cancer forming there.

When it comes to stem cell therapies, its caveat emptor buyer beware!

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Are Stem Cell Companies Abusing ClinicalTrials.gov? - PLoS Blogs (blog)

Okyanos Center for Regenerative Medicine to Hold Stem Cell Symposium in Freeport – Benzinga

First Annual Meeting Will Host Healthcare Administrators and Practitioners to Highlight Stem Cell Research Advances and Applications Through Expert Panel Discussions

Freeport, Grand Bahama (PRWEB) August 09, 2017

Okyanos Center for Regenerative Medicine has announced its First Annual Regenerative Medicine Symposium will take place at the Pelican Bay Hotel in Freeport, Grand Bahama on September 27, 2017. This daytime event is free to attend, however space is limited and pre-registration is required.

With oversight from the Ministry of Health's National Stem Cell Ethics Committee (NSCEC) and regulations laid out in the Stem Cell Research and Therapy Act passed in 2013, The Bahamas remains a leader in the global regenerative medicine community. Okyanos Center for Regenerative Medicine was the first cell therapy facility to meet the required standards and began treating patients in 2014.

Healthcare practitioners and administrators are encouraged to participate in the upcoming symposium which will feature specialist presentations, expert panel discussions and live Q&A sessions. The symposium will conclude in time for guests to attend the Okyanos-sponsored Grand Bahama Medical and Dental Association (GBMDA) welcome cocktail reception which will take place at 6:00pm on September 27th at the Pelican Bay.

"It is great to have this year's Grand Bahama Medical and Dental Association conference coordinated with the regenerative medicine symposium," said Dr. Vincent Burton who serves as Okyanos President and Chief Anesthesiologist as well as Vice President of the GBMDA. "The partnership we have forged should ensure an abundance of learning and networking opportunities for attendees."

Director of Research and Development Marc Penn, MD, PhD, FACC, will moderate the informative sessions and address the symposium to share an overview of Okyanos' planned research foci and strategic direction. "Through this annual meeting and others like it, we hope to encourage ongoing discussions which are critical to the development of the regenerative medicine industry both locally and internationally," said Dr. Penn.

To learn more and to register for Okyanos' First Annual Regenerative Medicine Symposium, please visit the Okyanos website.

ABOUT OKYANOS CENTER FOR REGENERATIVE MEDICINE (OH KEY AH NOS): Combining state-of-the art technologies delivered in a cell therapy center of excellence, Okyanos Center for Regenerative Medicine is a leading adult stem cell therapy provider located in Freeport, Grand Bahama. Okyanos was founded in 2011 and is licensed and accredited by the Bahamas' National Stem Cell Ethics Committee (NSCEC) under the Bahamas Stem Cell Therapy and Research Act to provide cell therapy to patients with chronic medical needs that, per scientific research, clinical trials and application, can be safely and potentially efficaciously treated with patients' own adipose-derived stem and regenerative cells. The literary name Okyanos, the Greek god of the river Okeanos, symbolizes restoration of blood flow. Learn more at http://www.okyanos.com.

For the original version on PRWeb visit: http://www.prweb.com/releases/2017/08/prweb14585069.htm

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Okyanos Center for Regenerative Medicine to Hold Stem Cell Symposium in Freeport - Benzinga

About Us – Stem Cell Medicine :: STEM CELL MEDICINE LTD.

COMPANY OVERVIEW Stem Cell Medicine's mission is to develop and commercialize cellular therapies in combination with pharmaceutical products to be used for tissue repair and for the treatment of inflammatory, immunological and neurological disorders.

The Company develops products from a number of tissue sources, such as adipose tissue stem cells for ischemic indications and from T cells for solid tumor-directed immunotherapies.

The Companys business plan calls for the engagement in collaboration with other companies, research institutions and medical centers. The aim of these collaborations is to shorten the industry's standard length of development cycles and expand the Companys technology and know-how in R&D, business development, marketing and management. Seeking partneships with companies that have products in development stages and early clinical development.

Stem Cell Medicine's facilities include state-of-the-art R&D laboratories and modern GMP manufacturing production rooms that, together with well-equipped analytical laboratories, provide an optimal environment for the development of products from inception to the clinic.

Additionally, the Company offers CMO services for products, including solid-form pharmaceuticals and injectibles,for use in clinical trials.

MISSION Stem Cell Medicine strives to facilitate the leap from existing stem cell R&D practices and technology and first-product development to pharmaceutical solutions by consolidating the existing stem cell know-how and expertise in Israel, Europe, USA and Asia (China). Stem Cell Medicine benefits from its privileged access to world class medical facilities, top research and the large pool of stem cell companies at various stages of development. THE FOUNDER Ehud Maroms career has circled around building companies that have a strong technical backbone in the fields of chemistry and life-sciences. Mr. Marom believes that in the future, stem cell product launches will continue to yield attractive returns. This outlook is based on a combination of the current known advancements in R&D, todays business and political/regulatory environment both in the U.S. and Israel, as well as the actual product launch successes we have seen to date. Mr. Marom had the privilege of playing a pivotal role in the early days of Gamida Cell, one of the leading Israeli biotech companies and a global leader in stem cell technologies and products. Mr. Marom led the development of the companys flagship product from pre-clinical to Phase III trials.

MANAGEMENT TEAM

Ehud Marom - Chairman & CEO Mr. Marom received his BSc in Chemical Engineering from the Technion Israel Institute of Technology with distinction. He brings vast experience in management, operations, business and strategic planning in the pharmaceutical industry, where he has held various senior positions over the years. Past positions include VP of Operations at Teva Pharmaceuticals' API and Innovative divisions, where he was credited for his contribution to the market success of Teva; COO of Peptor Ltd; CEO of the Jerusalem-based biotechnology company, Gamida Cell, a leader in hematopoietic (blood) stem cell therapeutics; President and CEO of Makhteshim Chemical Works Ltd., followed by position of Senior VP of Supply Chain at Makhteshim-Agan Group. In addition to his role as Chairman & CEO at Stem Cell Medicine, Mr. Marom also acts as Chairman & CEO of Mapi Pharma and Chairman of Pharma Two B.Dr. Frida Grynspan , VP R&D and Site ManagerDr. Grynspan has extensive experience in the areas of cellular therapeutics and protein chemistry. She served as VP R&D at CollPlant, Pluristem and Gamida Cell. Dr. Grynspan holds a PhD in Chemistry from the University of Illinois at Chicago and a post-doctoral degree from Harvard Medical School. Irit Zalayet - CFOMs. Zalayet CPA serves as Stem Cell Medicines CFO as of 2012. Prior to this Ms. Zalayet served as deputy CEO of Kesselman & Kesselman Trust Co. (1971) Ltd. and as a CPA at PwC Israel. Irit completed her Bachelors in Economics and Accounting and her M.A. in Law; both degrees are from The Bar-Ilan University. Ms. Zalayet also serves as the CFO of a related group party Pharma Two B. Ruth Reiss - Quality Assurance ManagerMs. Reiss joined Stem Cell Medicine in 2013. Prior to joining the company, she served as QA manager at Hy-Laboratories Ltd. She successfully led the company in its first FDA QP inspection in addition to GMP accreditation by the Israeli Ministry of Health. Ruth received her BSc in Agriculture from the Hebrew University in Jerusalem and a Business Management degree from the Open University of Israel.

Aviva Zyskind - Business Development Senior Associate Ms. Zyskind joined Stem Cell Medicine in 2014. Previously, she worked at KPMG in Israel where she founded the China Practice and worked as a member of the M&A team; and as International Project Coordinator at the Hisense R&D Center in China. She received her BA in Economics and Mandarin Chinese from Brandeis University and has lived and worked in China for three years.Dr. Yael Hayon - R&D Project ManagerDr. Hayon received her PhD in Neurobiology from Hebrew University Hadassah Medical Center and specializes in developing models of human disease and blood products within the fields of Stem Cells and Regenerative Medicine. Through the course of her work, she has registered a patent for clinical applications and presented her research in conferences around the world. Her findings have been published in five different journals. Prior to joining Stem Cell Medicine in 2014, Dr. Hayon has held a number of positions, including director of Cerebrovascular Research and Development at the Neurology and Hematology Departments and Deputy Director and Medical Advisor at the Blood Bank, Hadassah Medical Center.

Dr. Dotan Uzi - R&D Project Manager Dr. Uzi received his PhD in Medical Research from the Hebrew University Hadassah Medical Center and specializes in cellular metabolism and toxicity, gene therapy and human disease models as platforms for stem cell therapy. Prior to joining Stem Cell Medicine, he served as VP and Head of Research and Development at Clearance Ltd, and as Human Disease Model Consultant at BiolineRx. Dr. Uzi has published his work in leading journals and as a main author in a leading hepatology textbook. He has also received the Israel Association for the Study of the Liver's Award for Excellence twice.

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About Us - Stem Cell Medicine :: STEM CELL MEDICINE LTD.

Engineered Skin Cells Control Type 2 Diabetes in Mice: Study – Sioux City Journal

THURSDAY, Aug. 3, 2017 (HealthDay News) -- Scientists have created genetically altered skin cells that may control type 2 diabetes in lab mice. And they believe the general concept could someday be used to treat various diseases.

Using a combination of stem cells and "gene editing," the researchers created patches of skin cells that were able to release a hormone called GLP1 in a controlled manner.

The hormone, which is normally produced in the digestive tract, spurs the production of insulin -- the body's key regulator of blood sugar levels.

The scientists found that transplanting the engineered skin patches onto diabetic lab mice helped regulate their blood sugar levels over four months.

Xiaoyang Wu, a stem cell biologist at the University of Chicago, led the "proof of concept" study. He said it raises the possibility that "therapeutic skin grafts" could be used to treat a range of diseases -- from hemophilia to drug dependence.

Wu's team focused on type 2 diabetes in these initial experiments because it's a common condition.

However, a researcher not involved in the study doubted the usefulness of the approach for diabetes specifically.

People with type 2 diabetes already manage the disease with diet, exercise and medications -- including ones that target GLP1, said Juan Dominguez-Bendala.

Using high-tech gene therapy to get the same result seems unlikely, said Dominguez-Bendala, an associate professor at the University of Miami's Diabetes Research Institute.

"I don't see something like this coming to the clinic for diabetes," he said.

But Dominguez-Bendala also pointed to what's "cool" about the experiments.

Wu's team used a recently developed technology called CRISPR (pronounced "crisper") to create the skin patches. The technique, heralded as a major breakthrough in genetic engineering, allows scientists to make precision "edits" in DNA -- such as clipping a particular defect or inserting a gene at a specific location.

Before CRISPR, scientists could not control where an inserted gene would be integrated into the genome. It might end up in a "bad" location, Dominguez-Bendala explained, where it could, for example, "awaken" a tumor-promoting gene.

Wu and colleauges used CRISPR to make specific edits in GLP1, including one that allowed the gene to be turned "on" or "off" as needed, by using the antibiotic doxycycline.

The modified gene was inserted into mouse stem cells, which were then cultured into skin grafts in the lab. Finally, those grafts were transplanted onto lab mice.

The researchers found that when the mice were fed food with tiny amounts of doxycycline, the transplanted skin released GLP1 into the bloodstream. In turn, the animals' insulin levels rose and their blood sugar dipped.

The engineered skin also seemed to protect the mice from the ravages of a high-fat diet. When the mice were fed a fat-laden diet, along with doxycycline, they gained less weight versus normal mice given the same diet. They also showed less resistance to the effects of insulin, and lower blood sugar levels.

According to Wu, the study lays the groundwork for more research into using skin cells as a way to deliver "therapeutic proteins."

For instance, he said, skin cells could be engineered to provide an essential protein that is missing because of a genetic defect. As an example, he cited hemophilia -- a genetic disorder in which people lack a protein that allows the blood to clot properly.

Skin cells could be an ideal way to deliver such therapies, Wu said.

For one, the safety of skin grafts in humans is well-established, he pointed out. Since the 1970s, doctors have known how to harvest skin stem cells from burn victims, then use those cells to create lab-grown skin tissue.

Because the skin is generated from a patient's own stem cells, that minimizes the issue of an immune system attack on the tissue.

Dominguez-Bendala agreed that using skin cells has advantages. For one, he noted, the skin graft can be easily removed if something goes awry.

But a lot of work remains before therapeutic skin grafts could become a reality for any human disease. And research in animals doesn't always pan out in humans.

A next step, Wu said, is to see whether the skin grafts maintain their effects in lab mice over a longer period. The researchers will also monitor the animals for any immune system reactions against the GLP1 protein itself.

The findings were published online Aug. 3 in Cell Stem Cell.

The U.S. National Institutes of Health has a primer on gene therapy.

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Engineered Skin Cells Control Type 2 Diabetes in Mice: Study - Sioux City Journal

Qkine synchronises licensing deal – Global University Venturing

Qkine, a UK-based stem cell technology developer spun out from University of Cambridge, signed a key licensing agreement with the institutions tech transfer office Cambridge Enterprise on Tuesday.

The deal relates to Activin A production technology. Activin A, and related proteins, is one of the crucial elements in mimicking the environment in the human body and helps turn stem cells into specific cell types.

The technology was developed by co-founder Marko Hyvnen from the Department of Biochemistry.

Qkine was incorporated in November 2016 before securing a Pathfinder investment from Cambridge Enterprise the following month to facilitate setting up the business. It then began operations as an embedded company at the Department of Biochemistry in April.

Qkine aims to manufacture bioactive proteins that have applications in regenerative medicine and stem cell research. There is a need for this technology in a wide range of clinical areas, from disease modelling and drug screening to precision medicine.

MarkoHyvnen said: I have been providing growth factors to the Cambridge stem cell community for almost a decade.

Demand is growing from labs outside Cambridge and forming Qkine will allow us to focus on producing the highest quality cytokines for these scientists and establish a unique UK-based supplier of one of the enabling technologies for regenerative medicine, one of the priority areas for British manufacturing recently identified by the government.

Iain Thomas, head of life sciences at Cambridge Enterprise, said: Qkine is a great example of how opportunities are incubated in the university until the commercial time is right.

We are delighted that Qkine is taking this technology into the stem cell and regenerative medicine markets both of which are important and rapidly growing.

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Qkine synchronises licensing deal - Global University Venturing

Honor for pioneering equine stem cell researcher – Horsetalk

An equine cartilage disk, of about 4mm in diameter, is being used in trials in Canada, thanks to stem cell researcher Dr Thomas Koch.

An equine stem cell researcher is among theinaugural recipients of new University of Guelph internal awards recognizing research excellence and innovation.

Dr Thomas Koch, from Ontario Veterinary Colleges Department of Biomedical Sciences, has received a Research Excellence Award.

The awards recognize both researchers who are embarking on stellar careers and those whose research successes already set them apart from their colleagues in their disciplines globally, said University of Guelphvice-president (research) Malcolm Campbell.

Koch, who was recently recognized with a 2016 Early Researcher Award from the Ontario Ministry of Research and Innovation, focuses his research on stem cell biology, tissue engineering-based therapies and regenerative medicine. In particular he is studying the potential of stem cells to repair damage to joints and cartilage. His work on equine stem cells for cartilage repair includes finding better ways to treat horses, as well as using the horse as a model for testing new therapies for humans. Koch is also a founding member and current vice-chair of the North American Veterinary Regenerative Medicine Association.

In 2012, Koch isolated mesenchymal stromal cells (MSCs) for potential cartilage repair using a simple, non-invasive procedure.

He was recognised along with DrShayan Sharif, a professor of poultry immunology at the OVCs Department of Pathobiology, who received a Research Leadership Chair.

Drs Sharif and Koch are among our best: they were nominated by their peers, not only because of their outstanding scholarly accomplishments, but also because they are exemplary citizens of the University of Guelph, said OVC Dean Jeff Wichtel.

The Chair and the Award are well-deserved acknowledgements of their continued commitment to research excellence in their respective disciplines, and highlight once again OVCs strengths in translational medicine, food animal production, food safety and security.

Created by the U of Gs Office of Research and the Office of the Provost, the awards will be made annually.

Research Excellence awards are a one-time, $5000 award. Early career faculty who are one to two years post-tenure are eligible. Research Leadership Chairs are for well-established faculty who have demonstrated research excellence. The $15,000 awards are for three years, with a possible extension to five years.

Award winners will present their work to U of G and the wider Guelph community through special research events. Each of U of Gs seven colleges will be eligible for one Research Excellence Award recipient and up to two Research Leadership Chairs. Recipients are nominated and selected by their respective colleges. Awards are based on scholarly output, research-related knowledge mobilization, research-derived innovation and training of highly qualified personnel.

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Honor for pioneering equine stem cell researcher - Horsetalk

Speculator makes case for candidates to end years of hurt for stem cell investors – The Pharma Letter (registration)

Most early stage stem cell investors have lost their shirts, admits a market commentator as it puts forward

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Speculator makes case for candidates to end years of hurt for stem cell investors - The Pharma Letter (registration)

Dozens of US clinics sell unproven stem cell therapies for heart failure – Reuters

(Reuters Health) - Stem cell therapy isnt approved to treat heart failure in the U.S., but dozens of clinics nationwide advertise the treatments anyway, often charging thousands of dollars for procedures that may not be safe or effective, a new study suggests.

Researchers found 61 centers offering stem cell therapies for heart failure as of last year in the U.S. alone, including five that claimed to have performed more than 100 procedures. Only nine centers required copies of patients medical records and just one facility said it had a board certified cardiologist on staff.

We simply do not know anything about the quality of the treatment delivered at these centers, said senior study author Dr. Paul Hauptman director of heart failure at Saint Louis University Hospital.

These centers are not regulated in any way, Hauptman said by email.

Almost 6 million Americans have heart failure, and its one of the most common reasons older adults go to the hospital, according to the American Heart Association.

It happens when the heart muscle is too weak to effectively pump enough blood through the body. Symptoms can include fatigue, weight gain from fluid retention, shortness of breath and coughing or wheezing. Medications can help strengthen the heart and minimize fluid buildup in the body.

While some experimental stem cell therapies for heart failure are currently being tested in late-stage human trials, none have won approval from the U.S. Food and Drug Administration.

In theory, after a transplant, stem cells could permanently become part of the diseased heart and either help grow new healthy heart tissue or tell existing cells to work better, said Paul Knoepfler, a cell biology researcher at the University of California Davis School of Medicine in Sacramento who wasnt involved in the study.

Its also possible stem cells could temporarily visit the heart and stimulate a positive response in cells already there, he said.

Even though theres no conclusive proof yet that any stem cell treatments are safe and effective for heart failure, centers contacted for the study charge an average of $7,694 for each treatment using patients own stem cells and $6,038 for each procedure with donor stem cells.

In one instance, though, a clinic staff member said, If you have a million dollars to spend we will set you up with weekly infusions.

Hauptmans team had used a standard script when contacting each center, asking about the stem cell treatment itself, medical exams before and afterward and pricing.

Among the other responses they received from clinic staff were remarks such as, If you know anyone that can start an IV, a neighbor that is a nurse for example, we can send you the stem cells and that person can administer them to you and We hope you don't believe your doctor when they tell you there is nothing they can do, you were smart to call us.

None of the sites in the study discussed what methods they used to isolate or identify stem cells, though most claimed to use patients cells and 24 said they got cells from fat tissue.

Most centers claimed to deliver cells intravenously, researchers report in JAMA Internal Medicine.

This approach has been associated with complications such as stroke, in which infused cells block blood vessels in the brain, said Douglas Sipp, a researcher at RIKEN Center for Developmental Biology in Kobe, Japan, who wasnt involved in the study.

The biggest risk is that patients will waste their money, time and hopes on an unnecessary and useless invasive procedure, Sipp said by email.

If any stem cell treatment did ultimately prove safe and effective enough to win FDA approval, it would likely offer a significant improvement over the limited treatment options currently available, said Leigh Turner, a researcher at the University of Minnesota Center for Bioethics who wasnt involved in the study.

But its impossible to say what patients would get at unregulated clinics offering unapproved stem cell therapies, Turner said by email. In at least two cases unrelated to the current study, patients died after getting stem cell procedures at a clinic in Florida, and in another case at a different Florida clinic, a woman went blind, Turner noted.

Clinics marketing stem cell treatments to patients suffering from heart failure might be administering anything from slurries of mixed cells, some of which might be stem cells, to nothing more than cellular debris, Turner said. Often one can only speculate.

SOURCE: bit.ly/2uQve40 JAMA Internal Medicine, online July 24, 2017.

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Dozens of US clinics sell unproven stem cell therapies for heart failure - Reuters

The Big Deal About Stem Cell Therapies and Regenerative Medicine – PR Newswire UK (press release)

However, when looking at this great promise in terms of return on investment, let us be completely honest, most early stage stem cell investors have lost their shirts. We are now more than twenty years removed from the earliest commercial stem cell companies that were founded in the late 1980's, went public in the late 1990's and who were once seen as an exciting investment opportunity, but ended up being a huge disappointment.

So, should investors still be interested in regenerative medicine? After all, stem cells have largely produced failures and unregulated stem cell clinics marketing unproven therapies are taking over. The answer is a resounding yes, but the dot-com like era of regenerative medicine, which led investors to pour money into anything and anyone marketing a cell therapy is over. Investors will need to look at companies solving issues with stem cells or those taking a completely new approach.

One company that is looking to address many of the issues with stem cell therapies, as well as developing another approach to regenerative medicine is Endonovo Therapeutics, Inc. (OTCQB: ENDV). On the stem cell front, ENDV is using its Time Varying Electromagnetic Fields (TVEMF) technology, originally developed at the National Aeronautics and Space Administration (NASA) to expand and activate stem cells to produce more biologically potent cell therapies. However, more importantly, ENDV is developing a non-invasive medical device that would render many of the cell therapies currently under development obsolete. These devices, called Electroceuticals, harness the electrical signals that our cells and nerves use to control the immune and regenerative response to treat inflammatory and degenerative diseases. ENDV is developing this exciting technology for treating and preventing heart failure following a heart attack, to treat chronic kidney disease, peripheral artery disease and non-alcoholic steatohepatitis (NASH).

Another small biotech company like ENDV working on electric treatments for diseases is Pulse Biosciences (NASDAQ: PLSE), whose Nano-Pulse Stimulation (NPS) technology uses nano second electric pulses to illicit an immune response for the treatment of cancer. PLSE recently announced the treatment of its first patient in a study to evaluate the safety and efficacy of its novel NPS technology for seborrheic keratosis (SK) lesions. SK is one of the most common types of skin lesions, affecting more than 80 million patients in the United States. Additionally, PLSE announced that it will host its quarterly investor conference call on July 27, 2017, at 1:30 p.m. PDT / 4:30 p.m. EDT. The company will provide an update on the clinical advancement of the PulseTx[TM] System, including progress of the clinical study evaluating NPS for the treatment of seborrheic keratosis (SK), as well as the status of the 510(k) submission from earlier this year.

Another company seeking to address past pitfalls of stem cell therapies is Pluristem Therapeutics, Inc. (NASDAQ: PSTI) is a developer of placenta-based cell therapy product candidates for the treatment of multiple ischemic, inflammatory and hematologic conditions. Pluristem's products include PLX-PAD and PLX R18. The Company's PLX cells are adherent stromal cells (ASCs) that are expanded using a three dimensional (3D) process. The system utilizes a synthetic scaffold to create an artificial 3D environment where placental-derived stromal cells can grow. This process allows the cells to be expanded rapidly while remaining healthy and potent cells that can secrete therapeutic biomolecules. The Company's PLX products are administered using a standard needle and syringe. PSTI recently announced that Austria's regulatory health agency, the Austrian Agency for Health and Food Safety (AGES), had cleared Pluristem to begin enrollment in Austria for its pivotal Phase III trial of PLX-PAD cells to treat critical limb ischemia.

In other stem cell news:

Cytori Therapeutics, Inc. (NASDAQ: CYTX) recently announced that its STAR study assessing its Habeo Cell Therapy for the treatment of Scleroderma had failed to meet its primary endpoint at week 24 nor any of its secondary endpoints at week 24 or week 48. On the other hand, CYTX stated that there were 'clinically meaningful' improvements in both the primary and secondary endpoints of both hand function and scleroderma-associated functional disability compared to placebo in a subgroup of patients with diffuse cutaneous scleroderma, a more severe form of the disease. The company has stated that it will continue it analysis of the data before determining its next steps.

Capricor Therapeutics, Inc. (NASDAQ: CAPR) a biotechnology company developing biological therapies for Duchenne muscular dystrophy and other rare diseases, following news that Janssen Biotech, Inc. had decided not to exercise its option to exclusively license Capricor's lead candidate CAP-1002 for the development and commercialization in the field of cardiology, announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to CAP-1002, Capricor's development candidate for the treatment of Duchenne muscular dystrophy, a debilitating genetic disorder characterized by progressive weakness and chronic inflammation of skeletal, heart, and respiratory muscles. The Rare Pediatric Disease Designation, as well as the Orphan Drug Designation previously granted to CAP-1002 by the FDA, covers the broad treatment of DMD. Upon receiving market approval for CAP-1002 by the FDA, Capricor would be eligible to receive a Priority Review Voucher.

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The Big Deal About Stem Cell Therapies and Regenerative Medicine - PR Newswire UK (press release)

Regenexx Announces Successful Merger with Harbor View Medical – OrthoSpineNews

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BROOMFIELD, Colo.(BUSINESS WIRE)Regenexx, a Colorado-based stem-cell-treatment network and pioneer in the invention of interventional orthopedics, today announced that it successfully merged withHarbor View Medical, a leader in orthopedic stem cell therapy and part of the Regenexx network, which became effective in May 2017. As part of the transition, Jason Hellickson has assumed the CEO role. This merger positions Regenexx to further expand its National Network to better serve patients and our corporate partners.

Regenexx Corporate will be headquartered in Des Moines, IA, while Regenexxs Affiliate Program and Research and Development will be lead out of the companys Broomfield, CO location. Dr. Christopher Centeno, founder of orthopedic stem cell treatments and leader of interventional orthopedics in the United States and pioneer of the Regenexx patented procedures, will continue his role as Chief Medical Officer and remain in clinic operations in Broomfield, and continues the advancements of regenerative medicine through the largest research and data collection effort in orthopedic regenerative medicine.

As the most advanced non-surgical orthopedic care available in the United States, Im excited to continue our mission to producing the best possible patient outcomes through interventional orthopedics, said Jason Hellickson, CEO, Regenexx. In addition to individual personalized care, we will continue to provide both employers and their employees with cost savings results and successful interventions to orthopedic surgery.

Since joining the Regenexx Network in late 2014, Hellickson has reengineered clinic operations which increased capacity by more than 300 percent while offering a streamlined approach beneficial to both patients and clinic staff. He is the innovator and leader of theRegenexx Corporate Programthat enables large employers access to the Regenexx procedures. Since adding Regenexx procedures to their self-funded health and workers compensation plans, corporate partners have saved as much as 83 percent in their orthopedic surgical expenses, totaling in the many millions of dollars. In his new role, Hellickson will continue to architect the Regenexx national clinical operations to create more streamlined approaches to patient care and expand Regenexx clinics nationwide.

We look forward to continuing the build-out of Regenexx clinics, streamlining affiliate networks of more than 50 clinics nationwide, and adding additional clinics in major metropolitan areas including Chicago, Atlanta, Dallas, Philadelphia, and Charlotte under Jasons helm, said Christopher Centeno, MD. Were excited about the experience and enthusiasm that Jason brings to Regenexx.

Regenexx is the world leader in interventional orthopedics using orthobiologics and has been issued many patents for its evidence-based stem cell and blood platelet treatments used for back pain, joint pain, arthritis and acute orthopedic injuries. The benefits of interventional orthopedics are so revolutionary that seventy percent of orthopedic issues currently treated with surgery could instead be handled using regenerative methods. Mesenchymal stem cells are multipotent, adult stem cells that are therapeutic agents in the repair and regeneration of muscle, tissue, cartilage and bone. Regenexx procedures use a patients own bone marrow-derived stem cells, or blood platelets, through a blood draw, to customize needle-based, precisely-guided procedures to treat common orthopedic conditions. Its procedures have been proven to have the same or better outcomes compared to their surgical alternative.

For more information on the Regenexx Corporate Program call: 888-547-6667. For general information on Regenexx, please visitwww.Regenexxcorporate.com. For a map of current Regenexx clinics and providers clickhere.

About Regenexx and the Regenexx Physician Network The Regenexx Procedures are the nations most advanced non-surgical stem cell and blood platelet treatments for common joint injuries and degenerative joint conditions, such as osteoarthritis and avascular necrosis. These stem cell procedures utilize a patients own stem cells or blood platelets to help heal damaged tissues, tendons, ligaments, cartilage, spinal disc, or bone.

For more information on Regenexx, please visit:http://www.regenexx.com

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Regenexx Announces Successful Merger with Harbor View Medical - OrthoSpineNews