Category Archives: Stem Cell Clinics

Advice on Finding Legitimate Stem Cell Clinics – CBS News

Scientists are making progress in testing stem cells to treat a variety of diseases, but they're warning about clinics that push unproven treatments.

There are clinics "selling snake oil" all over the world, warns Sean Morrison, a stem cell expert at the University of Michigan.

The International Society for Stem Cell Research says it's concerned about aggressive marketing of treatments by clinics that may not have safeguards to ensure safety or likely benefit.

In June, the society launched a website - http://www.closerlookatstemcells.org - for people interested in such clinics. It has already attracted more than 10,000 hits.

Adult Stem Cell Research Leaving Embryos Behind"60 Minutes": Growing Body Parts

The website offers background information on stem cell research and suggests questions to ask at a particular clinic, such as:

What is the scientific evidence that this new procedure could work for my disease or condition? Where is this published?

Is there any independent oversight or accreditation of the clinic where the treatment will be done and the facility where the cells are processed?

What are the risks of the procedure and the possible side effects, both immediate and long-term?

The website also invites readers to submit the names of clinics, which the society will then contact for specific information as it builds a public list of facilities.

The list will reveal whether these clinics provided evidence of appropriate oversight and patient protections.

At a U.S. government website - http://www.clinicaltrials.gov - patients and families can search for formal treatment studies all over the world that are aimed at particular diseases.

The website's database currently details more than 90,000 clinical trials sponsored by federal agencies (such as the National Institutes of Health) and private industry.

Top 10 Things to Know About Stem Cell TreatmentsAdapted from the International Society for Stem Cell Research:

1. There are different types of stem cells, each with their own purpose.

It is unlikely that a single cell type could be used to treat a multitude of unrelated diseases that involve different tissues or organs. Be wary of clinics that offer treatments with stem cells that originate from a part of the body that is different from the part being treated.

2. A single stem cell treatment will not work on a multitude of unrelated diseases or conditions.

A major warning sign that a clinic may not be credible is when treatments are offered for a wide variety of conditions but rely on a single cell type.

3. Currently, there are very few widely-accepted stem cell therapies.

The range of diseases where stem cell treatments have been shown to be beneficial in responsibly conducted clinical trials is still extremely restricted (including diseases and conditions of the blood and immune system; restoring the blood system after treatments for specific cancers; some bone, skin and corneal diseases or injuries).

4. Just because people say stem cells helped them doesn't mean they did.

Be wary of clinics that measure or advertise their results primarily through patient testimonials, which may by unrelated to the actual stem cell treatment, arising from the "placebo effect," accompanying treatments, and natural fluctuations of the disease or condition.

5. A large part of why it takes time to develop new therapies is that science itself is a long and difficult process.

If a treatment has not been carefully designed, well studied and gone through the necessary preclinical and clinical testing, it is unlikely to have the desired effect. Even more concerning is that it may prove to make the condition worse or have dangerous side effects.

6. To be used in treatments, stem cells will have to be instructed to behave in specific ways.

Bone marrow transplantation is typically successful because we are asking the cells to do exactly what they were designed to do: make more blood. For other conditions, we may want the cells to behave in ways that are different from how they would ordinarily work in the body. Be wary of claims that stem cells will somehow just know where to go and what to do to treat a specific condition.

7. Just because stem cells came from your body doesn't mean they are safe.

While you are unlikely to have an immune response to your own cells, the procedures used to acquire, grow and deliver them are potentially risky. As soon as the cells leave your body they may be subjected to a number of manipulations that could change the characteristics of the cells, or contamination with bacteria, viruses or other pathogens. The procedure to either remove or inject the cells also carries risk.

8. There is something to lose by trying an unproven treatment.

It is easy to understand why people might feel they have nothing to lose from trying something even if it is unproven. However, there are very real risks of developing complications, both immediate and long-term, while the chance of experiencing a benefit is likely very low. Participating in an unproven treatment may also make a person ineligible to participate in upcoming clinical trials.

9. An experimental treatment offered for sale is not the same as a clinical trial.

The fact that a procedure is experimental does not automatically mean that it is part of a research study or clinical trial, using tested pretrial data and independent oversight by a medical group or ethics committee. Beware of expensive treatments that have not passed successfully through clinical trials.

10. Stem cell science is constantly moving forward.

Although it is sometimes hard to see, stem cell science is moving forward. There have been great advances in treating diseases and conditions of the blood system using blood-forming stem cells, and these show us just how powerful stem cell therapies can be.

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Advice on Finding Legitimate Stem Cell Clinics - CBS News

10 Best Clinics for Stem Cell Therapy in Mexico [2020 Prices]

Stem Cell Therapy involves the use of stem cells to treat different diseases. These are non-differentiated cells of a multicellular organism. All the cells in the body are specialized for a specific function but they are the only cells without an assigned function. They can differentiate into any type of cell as and when required by the body and can proliferate rapidly to produce multiple copies of a specific type. Sources of stem cells are embryos and adult body tissues. In the adults, stem cells are present in bone marrow, brain, liver, skin, skeletal muscles, blood and blood vessels. While embryonic stem cells are derived from a blastocyst. Nowadays, Umbilical cord is being stored under suitable conditions to get stem cells from it if needed. This is useful as chances of transplant rejection are less because stem cells are derived from your own umbilical cord.

Bone Marrow Transplant is the most commonly used method to treat various types of cancers such as lymphoma, multiple myeloma, and leukemia, etc. through stem cells. It is also used to treat brain diseases, cardiovascular diseases and cell deficiencies such as diabetes mellitus. Recently, anti-aging stem cell treatments have gain fame. It is used to restore your youth and beauty.

The procedure of stem cell therapy starts with removing stem cells from your body or from the donors body. The cells are collected from different body parts depending upon the need. After collection, the cells are processed according to the purpose for which they are extracted. The processed stem cells are injected into the specific area of your body using ultrasound or X-ray guidance. Anesthetics are used and the procedure is done under sterile conditions. It is necessary to make sure that the cells are reaching the desired area so that the improvement is better and quicker. There are three types of stem cell transplant:

Each type of stem cell transplant involves different methods, procedures, and techniques with different side effects and risks. The one suitable for you depends upon your age, health, and physical conditions.

The length of stay in the hospital varies in accordance with the condition for which stem cell therapy is being done. It is usually a 3 to 4 hours procedure (in-patient) in which stem cells are introduced into the body using syringes or catheter. Different factors are considered to decide the length of your stay in the hospital. These factors are:

Your stay in the hospital is longer for an allogeneic transplant as compared to an autologous transplant and you're free to leave Mexico the very next day, although it's advised to stay at least a few days in case you have further questions for the medical staff. But of course, these can be asked over the phone/email or directed towards your local medical team back home.

Complete recovery time varies from 2 to 12 weeks when the patient begins to feel pain relief. However, you can return to your routine work a couple of days after going through the transplant. Recovery depends upon your physical condition before and after the transplant. Over a period of 6 to 12 months, further improvements are seen in the patients. During the process, antibiotics and other drugs are prescribed. These drugs prevent transplant rejection and graft-host diseases. Allogenic stem cell transplant takes longer to recover than an autologous transplant.

It is advised to keep in contact with your doctor and to visit him/her on a regular basis. Apart from this, the following points should be considered:

There is asignificant success rate seen in patients having gone through the transplant, however, it is not always successful due to various reasons, one being the transplant rejection. This is common in the allogeneic type of stem cell transplant.

Exosomes are being used as an alternative to stem cell therapy. They are lipid bilayer surrounded vesicles secreted by live cells. They contain mRNA, proteins, chaperons, and various signaling molecules. They work as a natural carrier system for the transport of these substances. They function as a messenger within the body carrying information from one cell to the other. Stem cell therapy can be enhanced using exosomes. They help the bodys natural healing ability to increase the pace of recovery. Sometimes, stem cell therapy and exosomes are given together for better results.

Stem cell therapy is mostly being used for the treatment of cancer patients. Before the therapy, cancer cells are present within the body. After going through the therapy, stem cells replace cancer cells with healthy cells. This treats cancer, giving the patient a healthy life.

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10 Best Clinics for Stem Cell Therapy in Mexico [2020 Prices]

Canine Stem Cell Therapy Market Recent Trends, In-depth Analysis, Size and Forecast To 2027 | VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus,…

Contrive Datum Insights newly published a report, titled as Canine Stem Cell Therapy, which uses the primary and secondary research techniques to examine the different segments. The different evolutions, & recent trends that are responsible for the growth of the market have also been included in this report. This global Canine Stem Cell Therapy market is very highly inflamed in the regions such as North America, Latin America, Asia, China, Japan, Europe, and India. Facts and figures about the economic growth of the global competitors has been included in the statistical report. The data in terms of innovations, consumers, industries, and brands shape the future of the existing and upcoming businesses.

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Some of the key players profiled in the Canine Stem Cell Therapy market include: VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus, Aratana Therapeutics

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For product type segment, this report listed main product type of Canine Stem Cell Therapy market in gloabal and china: Allogeneic Stem Cells, Autologous Stem cells

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Chapter 6 Global Canine Stem Cell Therapy Market Segment, Type, Application

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Health: Is this company onto an alternative to stem cell therapy? – Stockhead

Many regenerative medicine companies on the ASX specialise in stem-cell therapies but Exopharm (ASX:EX1) is pursuing exosomes instead.

Exosomes, also known as Extra-corporeal Vesicles, are microscopic cellular couriers. These shift proteins and genetic information between cells and this can promote regeneration and healing of damaged cells.

In other words, they can tell cells they are a healthier, younger version of themselves successfully.

The challenge is that there are plenty of products on the black market but clinical research has been limited. But the research that has been done has shown exosomes can be lower risk, have higher scalability and even a superior therapeutic capacity.

This morning Exopharm announced BioMAP testing results of both its exosome products Plexaris and Cevaris.

These were compared with 4,500 experimental and sold medicines across a penal of 12 human primary cell-based systems.

Both products were deemed safe and had notable biological activity in tissue remodelling, inflammation and immune-modulatory related activities.

The results also showed that both products were not cytotoxic and did not cause anti-proliferative effects.

CEO Dr Ian Dixon declared the results were very positive.

The testing showed that both Plexaris and Cevaris had different and distinct activities to comparison drugs, he said.

This confirms our belief that exosomes are a distinct and potentially new class of medicine, different from existing medicines.

Exopharm recently began a phase one human clinical trial in Plexaris in a wound healing context. The company also has a technology (LEAP) that purifies exosomes for clinical purposes a necessary step to separate them from other biological fluids like serum.

Exopharm listed in December 2018 and rallied for a few months before a retreat in the second half of last year. But it is still above its IPO price and climbed 11.5 per cent this morning.

READ MORE:IPO Watch: Exopharm wants to raise $7m to help you live longer

National Veterinary Care (ASX:NVL) is about to be acquired but that hasnt stopped it adding four more vet clinics to its portfolio. Upon settlement of the deals, expected next month, it will own 107 clinics.

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Health: Is this company onto an alternative to stem cell therapy? - Stockhead

Mystery of Leaky Gut Plumbed by UCSD Team, Which Created Mini-Guts – Times of San Diego

Share This Article:A mini-gut organoid generated in the lab from human stem cells. Photo via ucsdnews.ucsd.edu

A team of UC San Diego School of Medicine researchers created a miniature gut in a lab to simulate and pinpoint the causes of a mysterious malady known as leaky gut, the school announced Monday.

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The condition occurs frequently in older patients, those with cancer or chronic illnesses and those with stressful lifestyles.

Essentially, the lining of intestines becomes more permeable, allowing bacteria and microbes to pass through the gut and contribute to diseases driven by chronic inflammation, such as inflammatory bowel disease, dementia, atherosclerosis and liver fibrosis, among others.

UCSD officials said it is difficult for physicians to tell who has leaky gut, and there are no treatments for it.

By taking biopsies from patients, researchers were able to take stem cells to create 3D models of human intestines to study the ailment. The organoids, or mini-guts, tell the story of the condition including revealing biomarkers which doctors could eventually use to diagnose and treat the condition, school officials said.

Dr. Pradipta Ghosh, professor of cellular and molecular medicine at UCSD School of Medicine and Moores Cancer Center, was first author of the report published in Life Science Alliance. Dr. Soumita Das, associate professor of pathology at UCSD School of Medicine, was the senior author.

According to the researchers, they rolled open the mini-gut balls to expose the surface of the intestinal lining. They then sprinkled on several types of bacteria, which stressed the gut lining junctions and caused them to fall apart. Those junctions between gut cells break down with aging and in the presence of colorectal tumors.

Each model gut differed from patient to patient, which Ghosh said was helpful to the research but also imposed limits.

Lots of research is done in mice that are inbred so that they are genetically identical, all in the same cage, eating the same diet, in order to remove these variables from the studies, she said. But lab mice are far more standardized than the same human from day to day, or patients we see in the clinics. Here, our model is a better representation of humanity. On the other hand, it also means that each organoid is its own unique experiment. We have to test many organoids to be able to make any claim, which we did in our study.

The researchers found that diabetes drug metformin activates an enzyme which helps tighten the cell junctions back up a potentially effective treatment for the condition.

The next step will be to look at diseases driven by leaky gut and to test various ways to tighten up those cell junctions.

I think youd be hard pressed to find a disease in which systemic inflammation is not a driver, Das said. Thats why, even though there are so many things we still dont know, were excited about the broad potential this model and these findings open for developing personalized leaky gut therapeutics.

To further advance these studies and others like it, Ghosh and Das lead HUMANOID, a core facility based at UCSD School of Medicine where researchers can access a number of different human organoids, including healthy or Alzheimers disease mini-brains and healthy or inflammatory bowel disease mini-guts, from both male and female patients at a variety of ages.

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Mystery of Leaky Gut Plumbed by UCSD Team, Which Created Mini-Guts was last modified: February 10th, 2020 by Ken Stone

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Mystery of Leaky Gut Plumbed by UCSD Team, Which Created Mini-Guts - Times of San Diego

Stem cell clinics much-hyped treatments lack scientific support – Science News

Joanna had just turned 62when she noticed that she couldnt stand very long before her right leg wouldhurt. She thought it was from an old injury, when her dog had slammed into herthigh. When the ache moved to her wrist, she went to a doctor who said shemight be getting arthritis.

Thepain quickly intensified. It just happened so rapidly, and I couldnt figureout why, says Joanna, who lives in a Houston suburb. Her doctors chalked it upto wear and tear. Youre getting older, she remembers them telling her.This was in early 2018.

Then she got an e-mail with a link to a video about stem cells and the conditions they could cure, including arthritis. I started watching it and then I just turned it off for a while because I thought, Im afraid Im going to get my hopes up too high, says Joanna, who asked that her last name not be used to protect her medical privacy.

Shestarted seeing full-page ads for stem cell seminars in the newspaper. Sheattended one at a local hotel, and the presenter announced that thousands ofpatients had benefited from stem cell injections. It was natural, the womansaid. No one had ever been harmed. The idea that the treatment wasnt a drugreassured Joanna.

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Shemade an appointment for the next day. It sounded too good to be true, but Iwas desperate, she says. She received injections into her back, neck andshoulder of stem cells from donated umbilical cord blood followed by an IV ofthe product the next day. The cost was $30,000, siphoned from her husbandspension. She knew she was taking a risk, but she felt hopeful.

Twodays later, her face began to burn and itch. Then her feet. She had pain inplaces that had never hurt before, like the joints of her fingers. Her hairstarted falling out, and she descended into a deep depression. Im totallymiserable, she says, months later. Im just agonizing in pain. Now I dontsee any hope.

Stem cells sold at clinics are driving whats thought to be a $2 billion global industry. Facebook pages announce seminars. Local newspapers are wrapped in ads vowing relief without surgery. Stem cells are billed as treatments for everything from autism to multiple sclerosis to baldness. Most commonly, the ads focus on orthopedic issues, especially aching knees.

Animportant point gets left out of the cheery ads: Theres not enough science tojustify using stem cells for any of the advertised conditions, including jointpain. None of the treatments advertised have been approved by the U.S. Food andDrug Administration. (The only approved stem cell treatments are for certaincancers and blood disorders.) Very few of the orthopedic studies in humans havebeen scientifically rigorous, and none have shown stem cells regrowingcartilage.

Itsnot even clear whether treatments being touted as stem cells contain viablestem cells or whether the contents should be defined as stem cells at all. Asthe stem cell industry grows rapidly, many researchers who are studying stemcells for their potential to regenerate tissues worry that the boomingmarketplace, which conflates hype with reality, might ultimately damageresearch progress.

The scientific and medical community ishaving to play defense, says Shane Shapiro of the Mayo Clinic Jacksonville inFlorida, who has conducted one of the very few published trials that comparedstem cells with a placebo for people with osteoarthritis. Misinformation andmisunderstanding about how cells are used to treat disease is proliferating.

The explosion of advertising reflects a dramatic turnaround from the controversy over stem cells that occupied the public in the early 2000s. At the time, scientists had learned how to generate lines of cells from embryos that were left over from in vitro fertilization and donated for research. In theory, the embryonic cells had the potential to treat disease by becoming a slew of different tissues, but their use became entangled with the politics of abortion. Then in 2001, President George W. Bush banned federal funding for research on embryonic stem cell lines not already in labs. Embryonic stem cell research has ridden the political tides since then: Restrictions were eased under Barack Obamas presidency, then Donald Trumps administration added restrictions on fetal tissue use.

Scientists tried to persuade the public to support the research by focusing on the great promise. They argued that stem cells might one day cure diseases by naturally repairing lost or damaged tissue. Actor Michael J. Fox, the most famous Parkinsons patient of his generation, testified to Congress in 1999 that stem cells could one day cure degenerative brain diseases. Joanna remembers Foxs passion. Thats what kind of made us aware of what stem cells were at the time, she says.

Broadly speaking, stem cells are cells capable of renewing themselves and taking on the identity of the tissue around them (SN: 3/19/16, p. 22). The early controversy about using embryonic cells has largely quieted down. The stem cells being marketed today are not embryonic; they come from bone marrow, fat tissue or birth products such as umbilical cord blood or amniotic fluid, all advertised as being able to regenerate cartilage. Clinic websites usually feature earnest testimonials with no hint of any possible negative side effects.

For the first part of the 2000s, stem cell treatments were largely sought through medical tourism. U.S. patients would travel to other countries for experimental treatments to cure diseases such as multiple sclerosis or spinal cord injury.

BioethicistLeigh Turner of the University of Minnesota in Minneapolis noticed a shiftaround 2012. One of the businesses that was part of that marketplace, acompany in South Korea, ended up popping up in the United States, he says. Thecompany, operating under the name Celltex, offered to remove stem cells from apatients own fat tissue, grow the cells in a lab and then reinject them.

Whenthe FDA sent a warning letter to the company in September 2012 stating that itsproducts must be approved before use in patients, the company moved itstreatments to Mexico. Regulations there are less stringent, though the businessremains headquartered in Houston.

Today, many clinics have learned how to operate just inside the margins of federal regulations, or simply ignore them. Turner and Paul Knoepfler of the University of California, Davis mapped the rise in U.S. stem cell clinics that market unapproved therapies, reporting in 2016 in Cell Stem Cell. The first few clinics emerged about 10 years ago, Turner says. By 2014, 2015, companies are pouring into the marketplace at a very rapid rate.

Knoepfler estimates that today more than 1,000 clinics across the country offer stem cells, though there are probably more because many doctors and chiropractors have simply added stem cells as a sideline to their main services. For some, stem cells are lucrative enough to support a business on its own. One in 4 stem cell providers in the Southwest offers the treatment exclusively, researchers at Arizona State University reported in August in Stem Cell Reports.

Thebusiness is extremely profitable, and the treatments are rarely covered byinsurance. Patients pay cash sometimes draining their life savings, takingout loans or drawing down retirement funds like Joanna did.

Often,when you go to business websites, theres not this kind of sober, frank,judicious accounting of risks and benefits or the possibility that theremight be no benefit, that someone could be harmed, Turner says. The websitestend to frame risks and benefits in a very misleading kind of way.

Andbecause each year tens of thousands of U.S. patients by Knoepflers estimate are getting cells in clinics outside of clinical trials, its difficult to knowexactly what the risks of the direct-to-consumer marketplace are. No one iskeeping track.

In 2018, researchers writing in Stem Cells Translational Medicine resorted to searching Google and the scientific literature, where they found 35 reports of serious consequences. Some patients in Florida lost their sight after getting stem cell injections into their eyes. In December, the FDA warned of serious illnesses in Nebraska linked to treatments with exosomes, products taken from placentas that are offered by some stem cell clinics.

A recent survey of neurologists, presented in March 2019 in Dallas at a meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis, asked doctors how their patients had fared after receiving unapproved stem cell treatments. About 25 percent of the 204 neurologists who responded said patients had suffered serious consequences such as strokes and seizures. Three doctors reported that patients had died. Without study, its impossible to know why.

It makes sense that treatments for knee pain appear to dominate the industry the potential customer base is large and growing. More than 600,000 people in the United States had knee replacement operations in 2014, according to data released in 2018 by the American Academy of Orthopaedic Surgeons. That number is expected to rise as baby boomers age and obesity rates climb. As the body ages, shock-absorbing cartilage in the joints wears away, which can lead to painful bone-on-bone rubbing. Stem cells are advertised as an easy way to avoid surgery.

Sofar, though, its not clear thats true. Recently, Maarten Moen, a sports medicinephysician at Bergman Clinics in Naarden, Netherlands, and his colleaguesreviewed every clinical trial he could find that examined using stem cells forknee osteoarthritis. Stem cells are prohibited for use in Holland, says Moen,a member of the medical staff of the Dutch Olympic Committee. Thats why wewere conducting this: to see if we could convince people in our country topossibly start using this therapy. But only if we answer these two questions:Is it helpful? And also, is it safe?

The groups results appeared in 2017 in the British Journal of Sports Medicine. The team found only six human studies testing stem cells for knees, and none were large trials that included a placebo comparison. While the treatment appeared safe, effectiveness couldnt be determined. Every study had methodological problems. As a result, the authors didnt recommend stem cells for knee osteoarthritis. Moen has recently updated his review, but those results have not yet been published. He offers a preview: The evidence didnt get any stronger. He found only two clinical reports that had compared the treatment with a placebo.

Bothwere from Shapiro, of the Mayo Clinic. Its been nearly three years since wefirst published our early results, Shapiro says. With his trial as the firstpiece of the puzzle, he expected that, like anything else in science, wewould be followed by a bunch of other trials. So far, other published resultshave not been pouring in.

Shapiroand colleagues from the Mayo Clinic and Yale University School of Medicine hadtested 25 patients with mild knee osteoarthritis in both legs. The researcherstook about 50 milliliters of cells from each patients bone marrow,concentrated the cells in the laboratory and then injected them back into oneknee of each patient. The other knee got an injection of saline as a placebo.The patients did not know which knee got the experimental treatment.

Both the stem cell knee and the placebo knee improved by about an equal degree about 50 to 75 percent on a pain scale, the team reported in 2017 in the American Journal of Sports Medicine. We werent able to conclude that the stem cell product was any superior in pain relief to anything else, he says. Additionally, we did not see any cartilage regrowth. A 12-month follow-up published in October in Cartilage found similar results.

The fact that the saline alone helped patients feel better was not surprising. A meta-analysis published in 2017 in the American Journal of Sports Medicine examined whether simple saline injections helped knee pain. That review, by researchers at Rush University Medical Center in Chicago and the University of Toronto, found that saltwater alone provided relief on the level of some drugs. But why the knees that got the bone marrow cells in Shapiros study improved to an equal degree is still unclear, he says. So hes not yet ready to say the stem cells dont work.

WhatI think actually happened is that we injected a therapeutic substance in one oftheir knees, and we injected a nonharmful substance, which is the saline, inthe other knee, and the patients were able to get back to their life for aperiod of time that overall made them feel better, he says.

The Mayo study tested stem cells from the patients own bone marrow. But clinics also offer cells from the bodys fat tissue, extracted by liposuction. Doctors can use enzymes to strip away extraneous cells from the fat, leaving only the regenerative cells. But that therapy is also unproven. One study, conducted by researchers in Australia and published in February 2019 in Regenerative Medicine, involved 30 patients with knee osteoarthritis. Patients who received stem cells from fat reported a 69 percent improvement in their pain, compared with no change in a comparison group that did not receive the treatment. But that study offered no placebo injection for comparison.

A second study, by a South Korean team, had a placebo, but a small number of patients. Twelve patients who received stem cells from their own fat had a 55 percent improvement in pain (based on their responses to a questionnaire) compared with no substantial improvement among 12 patients who got a placebo shot, the researchers reported in March 2019 in Stem Cells Translational Medicine. Cartilage didnt regrow with stem cells, but it didnt shrink, which it did in the placebo group.

Butthe treatments in those studies differ from what is actually offered at stemcell clinics. In both of those studies, the researchers expanded orconcentrated the cells in the laboratory before injecting them into patients apractice that is allowed in the United States only in a scientific study. UnderFDA rules, U.S. stem cell centers are only allowed to move a patients owntissue from one place to another, with little manipulation of the cells,otherwise the treatment may be considered an unapproved drug.

Sports medicine physician Kenneth Mautner and colleagues at Emory University in Atlanta compared outcomes for 76 patients with arthritis who received a treatment that was closer to what doctors can do in their offices. Each patient received either cells taken from their own bone marrow or from fat tissue. In both cases, the cells were simply moved to another place within the patients own body. After six months, both groups showed pain reductions and neither treatment was better than the other, the researchers reported in the November 2019 Stem Cells Translational Medicine. There was about 70 to 75 percent improvement for those who actually did improve, Mautner says. About one-quarter of the patients did not get better. Patients with more advanced arthritis were less likely to benefit.

Buthis study had that common shortcoming: no placebo comparison. When yourepaying a lot of money, theres obviously a placebo effect, Mautner says. Itsnot just your mind convincing you that you feel better. The placebo effect canactually be chemicals and cytokines that then produce anti-inflammatory effectsin your joints.

Inaddition to bone marrow and fat tissue, a growing number of clinics areoffering products made from donated umbilical cord blood or other birthproducts, Knoepfler says. Those cells are easy to administer and dont requirethe expertise to extract cells from the body.

Butif there is little evidence for the effectiveness of stem cells from fat andbone marrow, Shapiro says, there is zero support for umbilical products inhuman studies. Im not even studying them yet, he says.

Hardly any evidencesupports the idea that treatments marketed as stem cells can regenerate worntissue, which is what many patients think they are buying. Theres very littleevidence that it will regrow your cartilage, says orthopedic surgeon JasonDragoo of the University of Colorado Denver.

Hisresearch team is conducting a study to see whether there are treatments thatmight increase cartilage thickness. One study pairs the cellular treatment withsurgery. The existing tissue may be more receptive to regrowth, he says, ifyou clear away the debris and all the other things, get it as cleaned up aspossible, then give the cells. Hes also conducting a study comparing theability of cells from fat to repair tiny tears in cartilage that is otherwisemostly healthy, a process he compares with filling potholes.

Buteven if cartilage wont regrow, he and others say, the procedure may stillreduce inflammation, which could quiet a painful knee. Theres also earlyevidence from animal studies that cells from bone marrow or fat might sendchemical signals that jump-start a persons own healing.

Biomaterials scientist Sowmya Viswanathan of the University of Toronto and colleagues reported a study of 12 patients receiving bone marrow cells in August in Stem Cells Translational Medicine. The study had no control group. We saw improvement in symptoms, in pain, in quality of life and in joint stiffness for all the patients. These are the things that the patients care about. The fact that it doesnt regenerate cartilage doesnt disprove its ability to still be a functional, useful cell therapy, she says. It might work, but maybe not in the way that patients expect.

Viswanathan worries thatthe current stem cell market is exploiting the work of scientists, piggybackingoff of the legitimate but early studies for immediate commercial gain, shesays.

Everythinggets called stem cells. Nomenclature is still very important because if youcant name it properly, then you dont even know that youre talking about twodifferent or three or four different things, she adds.

Many clinics call the cells in their products mesenchymal stem cells, a term taken from a 1991 paper by biologist Arnold Caplan of Case Western Reserve University in Cleveland. Yet in 2017 in Stem Cells Translational Medicine, Caplan advocated for a name change: Stem cell misconceptions have led some practitioners in the United States and worldwide to advertise the availability of stem cell treatments (i.e., MSCs can cure the blind, make the lame walk and make old tissue young again).

Viswanathan and other members of the International Society for Cellular Therapy published a position statement in October in Cytotherapy that cells commonly identified as mesenchymal stem cells should more precisely be called mesenchymal stromal cells in the scientific literature to reflect the lack of evidence that, when used as a medical treatment, those cells can renew themselves and form different tissues. (Stromal cells form the bodys connective tissue.) As long as everything is called stem cells, she says, clinics focused on profits will be able to exploit legitimate research for marketing purposes.

Andthere are so many questions left to answer. She worries about what happens whenpeople have bad reactions, like Joanna did. We dont fully understand repeatinjections. We dont know the dosing. If there is an adverse event, then what?she says. Then it sets back the kind of legitimate work thats being donebecause the difference isnt apparent to the funders and to the lay publicbecause everyones calling it exactly the same thing.

Continued here:
Stem cell clinics much-hyped treatments lack scientific support - Science News

Europe’s guardian of stem cells and hopes, real and unrealistic – Yahoo News

Poland has emerged as Europe's leader in stem cell storage, a billion-dollar global industry that is a key part of a therapy that can treat leukaemias but raises excessive hopes.

Submerged in liquid nitrogen vapour at a temperature of minus 175 degrees Celsius, hundreds of thousands of stem cells from all over Europe bide their time in large steel barrels on the outskirts of Warsaw.

Present in blood drawn from the umbilical cord of a newborn baby, stem cells can help cure serious blood-related illnesses like leukaemias and lymphomas, as well as genetic conditions and immune system deficits.

Polish umbilical cord blood bank PBKM/FamiCord became the industry's leader in Europe after Swiss firm Cryo-Save went bankrupt early last year.

It is also the fifth largest in the world, according to its management, after two companies in the United States, a Chinese firm and one based in Singapore.

Since the first cord blood transplant was performed in France in 1988, the sector has significantly progressed, fuelling hopes.

- Health insurance -

Mum-of-two Teresa Przeborowska has firsthand experience.

At five years old, her son Michal was diagnosed with lymphoblastic leukaemia and needed a bone marrow transplant, the entrepreneur from northern Poland said.

The most compatible donor was his younger sister, Magdalena.

When she was born, her parents had a bag of her cord blood stored at PBKM.

More than three years later, doctors injected his sister's stem cells into Michal's bloodstream.

It was not quite enough for Michal's needs but nicely supplemented harvested bone marrow.

As a result, Michal, who is nine, "is now flourishing, both intellectually and physically," his mum told AFP.

A cord blood transplant has become an alternative to a bone marrow transplant when there is no donor available, with a lower risk of complications.

Stem cells taken from umbilical cord blood are like those taken from bone marrow, capable of producing all blood cells: red cells, platelets and immune system cells.

Story continues

When used, stem cells are first concentrated, then injected into the patient. Once transfused, they produce new cells of every kind.

At the PBKM laboratory, "each container holds up to 10,000 blood bags... Safe and secure, they wait to be used in the future," its head, Krzysztof Machaj, said.

The bank holds around 440,000 samples, not including those from Cryo-Save, he said.

If the need arises, the "blood will be ready to use without the whole process of looking for a compatible donor and running blood tests," the biologist told AFP.

For families who have paid an initial nearly 600 euros ($675) and then an annual 120 euros to have the blood taken from their newborns' umbilical cords preserved for around 20 years, it is a kind of health insurance promising faster and more effective treatment if illness strikes.

But researchers also warn against unrealistic expectations.

- Beauty products -

Haematologist Wieslaw Jedrzejczak, a bone marrow pioneer in Poland, describes promoters of the treatment as "sellers of hope", who "make promises that are either impossible to realise in the near future or downright impossible to realise at all for biological reasons."

He compares them to makers of beauty products who "swear their cream will rejuvenate the client by 20 years."

Various research is being done on the possibility of using the stem cells to treat other diseases, notably nervous disorders. But the EuroStemCell scientist network warns that the research is not yet conclusive.

"There is a list of almost 80 diseases for which stem cells could prove beneficial," US haematologist Roger Mrowiec, who heads the clinical laboratory of the cord blood programme Vitalant in New Jersey, told AFP.

"But given the present state of medicine, they are effective only for around a dozen of them, like leukaemia or cerebral palsy," he said.

"It's not true, as it's written sometimes, that we can already use them to fight Parkinson's disease or Alzheimer's disease or diabetes."

EuroStemCell also cautions against private blood banks that "advertise services to parents suggesting they should pay to freeze their child's cord blood... in case it's needed later in life."

"Studies show it is highly unlikely that the cord blood will ever be used for their child," the network said.

It also pointed out that there could be a risk of the child's cells not being useable anyway without reintroducing the same illness.

Some countries, such as Belgium and France, are cautious and ban the storage of cord blood for private purposes. Most EU countries however permit it while imposing strict controls.

- Rapid growth -

In the early 2000s, Swiss company Cryo-Save enjoyed rapid growth.

Greeks, Hungarians, Italians, Spaniards and Swiss stored blood from their newborns with the company for 20 years on payment of 2,500 euros upfront.

When the firm was forced to close in early 2019, clients were left wondering where their stem cells would end up.

Under a kind of back-up agreement, the samples of some 250,000 European families were transferred for storage at PBKM.

The Polish firm, founded in 2002 with two million zlotys (around 450,000 euros, $525,000), has also grown quickly.

Present under the FamiCord brand in several countries, PBKM has some 35 percent of the European market, excluding Cryo-Save assets.

Over the last 15 months, outside investors have contributed 63 million euros to the firm, PBKM's chief executive Jakub Baran told AFP.

But the company has not escaped controversy: the Polityka weekly recently published a critical investigative report on several private clinics that offer what was described as expensive treatment involving stem cells held by PBKM.

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Europe's guardian of stem cells and hopes, real and unrealistic - Yahoo News

Why stem cells could be the medical innovation of the century – World Economic Forum

Right now, your bodys stem cells are working hard replacing your skin every two weeks, creating new red and white blood cells and completing thousands of other tasks essential to life. They are your own personalized fountain of youth.

Scientists generally agree that a stem cell should be able to do both of the following:

One theory of ageing suggests that between the ages of 30 and 50, our stem cells reach a turning point and start to decline in number and function. This results in the typical features associated with ageing.

There does not seem to be a single discoverer of stem cells. Accounts date back to the 1800s and even further, but the first successful medical procedure was a bone marrow transfusion in 1939. Advances in immunology led to donor matching, initially via siblings and close relatives. Unrelated donor matching flourished in the 1970s, alongside donor registries.

In the 1980s, scientists identified embryonic stem cells in mice, leading to the 1997 cloning of Dolly the Sheep. This created immense interest for human and medical applications and a backlash in the US as federal R&D funding was essentially halted in 2001.

In 2012, a Nobel Prize was awarded for the earlier discovery of induced pluripotent stem cells (iPS). Essentially, they return potency and self-renewal properties to mature non-stem cells, essentially making them act like stem cells again.

In the decade between 2010 and 2019, the first wave of stem cell start-ups emerged, alongside R&D programmes at many large pharmaceutical companies, leading to innovation and the first human clinical trials for iPS and other related therapies.

According to Q3 2019 data from the Alliance for Regenerative Medicine, there are 959 regenerative medicine companies worldwide sponsoring 1,052 active clinical trials; 525 of these companies are in North America, 233 in Europe and Israel, and 166 in Asia. In aggregate, $7.4 billion has been invested in regenerative medicine companies in 2019; $5.6 billion of which has been dedicated to gene and gene-modified cell therapy, $3.3 billion in cell therapy, and $114 million in tissue engineering.

Overview of the cancer stem cells market

Perhaps most excitingly, curative therapies are hitting the market and the results are astonishing: 60% of Acute Lymphoblastic Leukemia patients taking Novartis Kymirah showed a complete response (no traces of cancer) and were declared in full remission. Meanwhile, 75% of patients with Transfusion-Dependent -Thalassaemia treated with bluebird bios Zynteglo achieved independence from transfusions. Perhaps most astonishingly, 93% of spinal muscular atrophy patients treated with Novartis Zolgensma were alive without permanent ventilation 24 months after treatment. We should expect more medical breakthroughs in the coming years.

New science, new start-ups: several companies in the sector have gone public or been acquired. These exits led to the recycling of talent and capital into new companies. Because the science and commercial systems have also advanced, the companies in the next wave are pursuing bigger challenges, driving innovation, with even greater resources.

Patients are eager: the current market for stem cell therapies is growing at 36% per year, though it will rapidly expand when a breakthrough occurs toward the treatment of a non-communicable disease (such as cancer, diabetes, heart disease) or a lifestyle factor (for example, growing hair in the correct places, expanding cognitive abilities or increasing healthy lifespan).

New R&D models: funding is flowing into the sector from large companies, VC funds, and institutions such as the California Institute for Regenerative Medicine (CIRM) and New York State Stem Cell Science programme (NYSTEM). Some of the leading university R&D platforms include the Center for the Commercialization of Regenerative Medicine in Toronto, the Stanford Institute for Stem Cell Biology and Regenerative Medicine, the Oxford Stem Cell Institute, and most notably, the Harvard Stem Cell Institute (HSCI).

Founded in 2004, HSCI has established a phenomenal track record. It provided the first $200,000 in funding to Derrick Rossis lab, which inspired the largest biotech IPO to date. HSCI scientists were also co-founders or principals in the three most prominent gene-editing companies (CRISPR Tx, Intellia and Editas), the combined $1.55-billion True North/iPierian acquisitions and the recent $950-million acquisition of Semma Tx, Frequency Tx, Fate Tx, Epizyme Inc., and Magenta Tx.

For the casual investor, Evercore ISI is building a Regenerative Medicine Index, which may be the simplest way to build a portfolio. For institutions and those with deeper pockets, regenerative medicine funds are forming, including the Boston-centric Hexagon Regenerative Medicine Fund, which aims to create companies out of the Harvard Stem Cell Institute.

Caveat emptor. Though patients needs are immediate, those seeking treatments should think very carefully about the risks. There are many dubious clinics touting expensive stem cell treatments and some patients have experienced horrifying complications. Dr. Paul Knoepfler of UC-Davis has written a practical and scientifically accurate guide, a strongly recommended read if you or a family member are considering treatment or a clinical trial.

The leading causes of death in 1900 were mostly infectious/communicable diseases. While the prevalence of most causes has diminished, the largest increases include heart disease (+40%) and cancer (+300%). Granted, this is partly due to doubling life expectancy and a lack of death from other causes. However, given time and resources, scientists and physicians may cure these challenging diseases.

Total disease burden by disease or injury

Today, six of the seven leading causes of death are non-communicable diseases (heart disease, stroke, lung diseases, cancer, Alzheimers disease and diabetes). Based on the early promise mentioned above, regenerative medicine may be our best hope to solve the great non-communicable diseases of our time, and perhaps the single most transformative medical innovation in a century.

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Orthobiology Market Innovative Technologies, Current And Future Trends – PharmiWeb.com

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Orthobiology Market Innovative Technologies, Current And Future Trends - PharmiWeb.com

Where Are They Now? Top 3 Biotech Startups From NextGen Bio Class of 2018 – BioSpace

Every year, BioSpace analyzes the biotech industry, looking for the hot new biotech startups to watch. We then produce the NextGen Bio Class of, twenty companies ranked based on several categories, including Finance, Collaborations, Pipeline, and Innovation. The companies were typically launched no more than 18 months before the list was created.

We thought it would be insightful to look back at our previous lists to see where some of those companies are today. Heres a look at the top three companies from the Top 20 Life Science Startups to Watch in 2018.

#1. BlueRock Therapeutics. Founded in 2016, BlueRock was #1 on our list of companies to watch in 2018. With facilities in Ontario, Canada; Cambridge, Massachusetts; and New York, New York, BlueRock launched in December 2016 with a $225 million Series A financing led by Bayer AG and Versant Ventures. The company focuses on cell therapies to regenerate heart muscle in patients who have had a heart attack or chronic heart failure, as well as therapies for patients with Parkinsons disease.

In October 2017, BlueRock and Seattle-based Universal Cells entered into a collaboration and license deal to create induced pluripotent stem (iPS) cell lines that can be used in the manufacture of allogeneic cellular therapies. Shortly afterwards, the company established its corporate headquarters in Cambridge, and in April 2018, established a research-and-development hub in New York City, as well as formalizing a sponsored research collaboration with the Center for Stem Cell Biology at Memorial Sloan Kettering (MSK) Cancer Center. The collaboration focuses on translating Ketterings expertise in creating multiple types of authentic neural cells from stem cells to address diseases of the central and peripheral nervous system. BlueRock also received $1 million from the State of New York and Empire State Development under its economic development initiatives program.

In April 2019, BlueRock partnered with Editas Medicine (which was on BioSpaces NextGen Bio Class of 2015 list) to combine their genome editing and cell therapy technologies to focus on novel engineered cell medicines. Part of the deal was to collaborate on creating novel, allogeneic pluripotent cell lines using a combination of Editas CRISPR genome editing technology and BlueRocks iPSC platform.

And finally, in August 2019, Bayer AG acquired BlueRock for the remaining stake in the company for about $240 million in cash and an additional $360 million in pre-defined development milestones.

#2. Prelude Fertility. Prelude Fertility is a bit of an outlier from the typical BioSpace NextGen company, because it isnt quite a biopharma company. It is a life sciences company whose business model is aimed at in vitro fertilization and egg freezing. It was founded with a $200 million investment by entrepreneur Martin Varsavsky. The investment was in the largest in vitro fertilization clinic in the Southeast, Reproductive Biology Associates of Atlanta, and its affiliate, My Egg Bank, the largest frozen donor egg bank in the U.S.

Since then it has expanded in various parts of the country, including adding San Francisco-based Pacific Fertility Center (PFC) to its network in September 25, 2017; partnering with Houston Fertility Institute and acquiring Vivere Health; partnering with the Advanced Fertility Center of Chicago; and in October 2018, partnered with NYU Langone Health.

In March 2019, Prelude merged with Inception Fertility to establish the Prelude Network as the fastest-growing network of fertility clinics and largest provider of comprehensive fertility services in the U.S. Inception is acting as the parent company, with the Prelude Network, both having board representatives from the previous organizations.

#3. Relay Therapeutics. Ranking #3 on our list for 2018, Relay Therapeutics launched in September 2016 with a $57 million Series A financing led by Third Rock Ventures with participation form D.E. Shaw Research. On December 14, 2017, it closed on a Series B round worth $63 million, led by BVF Partners, with new investors GV (formerly Google Ventures), Casdin Capital, EcoR1 Capital and Section 32.

The company focuses on the relationship between protein motion and function. It merges computational power with structural biology, biophysics, chemistry and biology. In December 2018, the company completed a $400 million Series C financing. It was led by the SoftBank Vision fund and included additional new investors, Foresite Capital, Perceptive Advisors and Tavistock Group. Existing investors also participated.

The company announced at the time it planned to use the funds to accelerate the implementation of its long-term strategy, expanding its discovery efforts, advancing existing programs into the clinic and improving its platform.

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Where Are They Now? Top 3 Biotech Startups From NextGen Bio Class of 2018 - BioSpace