Archive for the ‘Stem Cell Clinic’ Category

FDA Reaffirms Its Commitment to the Approval of Stem Cell Therapies Amidst Enforcement Actions Against … – JD Supra (press release)

Stem Cell Clinic | Posted by admin
Sep 03 2017

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FDA Reaffirms Its Commitment to the Approval of Stem Cell Therapies Amidst Enforcement Actions Against ... - JD Supra (press release)

Around the world – Bend Bulletin

Stem Cell Clinic | Posted by admin
Aug 29 2017

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Travel ban in the courts In the latest arguments over President Donald Trumps travel ban, a three-judge panel of a federal appeals court in Seattle indicated Monday it would continue allowing grandparents and other relatives of U.S. residents to travel to the U.S. from six predominantly Muslim countries. But the judges were less forthcoming about their views on exceptions to a second part of the ban, suspending the nations refugee program. In July in a provisional ruling, the Supreme Court allowed exceptions to the ban for many relatives but not for most refugees. The Supreme Court will hear arguments in the case in October.

Stem cell clinic crackdown The Food and Drug Administration announced a crackdown on dangerous stem cell clinics Monday, while pledging to ease the path to approval for companies and doctors with legitimate treatments in the field. The agency reported actions against two large stem cell clinics and a biotech company, saying it was critical to shut down unscrupulous actors in regenerative medicine, which includes stem cell and gene therapies and immunotherapies. Stem cells can develop into many different types of cells, and are thought to have the potential to repair or replace damaged tissue. But the FDA has approved only a few stem-cell products.

Trump timed Arpaio pardon for storm ratings President Donald Trump offered a fiery defense Monday of his decision to pardon former Arizona Sheriff Joe Arpaio as Hurricane Harvey made landfall in Texas last week and claimed he timed it to attract maximum attention as television viewers were glued to storm coverage. Trump also suggested the Justice Department had political motives during the Obama administration for charging the former sheriff in a case concerning his illegal profiling of Hispanics. Actually, in the middle of a hurricane, even though it was a Friday evening, I assumed the ratings would be far higher than they were normally, Trump said.

European migrant influx Measures intended to stop migrants from trying to cross the Mediterranean were at the center of discussions in Paris among four European leaders who met with the leaders of three African countries Monday. The meeting, billed as a minisummit, brought together the leaders of France, Germany, Italy and Spain as well as Chad and Niger and one of Libyas leaders. Chad and Niger are transit countries for people fleeing war or poverty, while Libya is a departure point for crossing the Mediterranean and a center for traffickers who promise to get people to Europe.

Kenyas strict plastic bag ban Kenya will now punish with up to four years in jail anyone making, selling or importing plastic bags, putting in place one of the worlds toughest bans on the ubiquitous item that is blamed for clogging oceans and killing marine life. The rule, announced in March and put into effect Monday, also means garbage bags will be taken off supermarket shelves and visitors entering Kenya will be required to leave duty-free shopping bags at the airport. Kenya joins more than 40 other countries including China, the Netherlands and France that have introduced taxes on bags or limited their use.

German nurse suspect in 86 deaths A German nurse serving a life sentence for murdering two of his patients is believed to have killed at least 86 people entrusted to his care, officials said Monday, in what they described as an imagination-defying series of crimes. The nurse, identified as Niels Hoegel, was sentenced to life in February 2015, after a court found him guilty of administering overdoses of heart medication to some patients in an intensive care ward where he worked from 1999 to 2001. He was convicted of two counts of murder, two counts of attempted murder and causing bodily harm to patients and is serving his sentence. During his trial, the former nurse confessed to intentionally inducing cardiac crises in 90 of his patients, 30 of whom he said had died. That prompted officials to launch an investigation into the deaths of some 130 of Hoegels former patients. The results were presented Monday in Oldenburg. Authorities are waiting for the results of 41 toxicology reports, the results of which could drive the number of confirmed deaths even higher

Indian guru rape sentencing An Indian court sentenced a well-known guru to at least 10 years in prison for rape Monday, three days after followers angered by his conviction engaged in violent protests. Gurmeet Ram Rahim Singh was found guilty Friday of having raped two women more than a decade ago. Thousands of Singhs followers had gathered in the state where the verdict was announced. They responded by smashing cars, setting fire to buildings and attacking police officers, and the violence later spread to other cities in northern India. At least 38 people were killed, and more than 250 were injured.

Border dispute in Asia India and China agreed Monday to back away from their confrontation over a tiny slice of territory high in the Himalayas, easing tensions between the worlds two most populous countries. Both sides agreed to give some ground in order to end the standoff. In a short statement, the Indian government said it had reached an understanding with Beijing. China seemed willing to compromise but still claims the territory.

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Excerpt from:
Around the world - Bend Bulletin

Daily on Healthcare: Lack of bare counties doesn’t solve Obamacare’s problems – Washington Examiner

Stem Cell Clinic | Posted by admin
Aug 29 2017

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Lack of bare counties doesnt solve Obamacares problems: Supporters of Obamacare have been celebrating that as of last week, every county will have at least one insurer offering plans on the exchange in 2018. Though that is better than a catastrophic scenario in which people in large swaths of the country do not have any options to buy insurance on the individual market, to celebrate this is to substantially move the goalposts for Obamacare. Even though there will be no bare counties, nearly a quarter of the counties will have only one insurer and nearly half of the counties will have a choice of two. That is a far cry from the way the law was sold as providing a wide array of options just like Orbitz or Expedia, but for health insurance. My guiding principle is, and always has been, that consumers do better when there is choice and competition, former President Barack Obama said in making the case for his healthcare law before a joint session of Congress in September 2009.

Costs still rising for consumers: Those who do not qualify for subsidies under Obamacare are facing significantly higher costs for their policies. And those whose current insurer isn't providing coverage for 2018, whether subsidized or not, likely will have to change doctors and hospitals to make sure they aren't slammed with high out-of-pocket medical expenses. The cutoff for when people have to pay full price is at a gross income of $48,240 a year for an individual and $98,400 for a family of four. For Carol Ray, 62, who lives in Arizona and whose gross income is $70,000 a year, premiums that she pays this year doubled to $1,182.78 a month. The bronze-level plan carries a $6,500 deductible for an individual or $13,100 for her and her husband. "I can write the check for it, so I guess you could say it's affordable," Ray said. "What I vacillate on is whether it's reasonable ... I'm not of unlimited funding ... At some point, I have to be pretty careful about what I'm spending.

Welcome to Philip Kleins Daily on Healthcare, compiled by Washington Examiner Managing Editor Philip Klein (@philipaklein), Senior Healthcare Writer Kimberly Leonard (@LeonardKL) and Healthcare Reporter Robert King (@rking_19). Email dailyonhealthcare@washingtonexaminer.com for tips, suggestions, calendar items and anything else. If a friend sent this to you and youd like to sign up, click here. If signing up doesnt work, shoot us an email and well add you to our list.

Sen. Dean Heller between a rock and a hard place: The Nevada Republican is confronting attacks over his votes on legislation to repeal Obamacare by touting his vote for a bill that was never supposed to become law. Heller, who is up for re-election in 2018 and is considered one of the most vulnerable Republicans, angered conservatives when he flip-flopped by voting against a bill that he voted for in 2015 that would have immediately gutted Obamacare without a replacement. He also faces attacks from his Democratic challenger, who says he went back on a promise to not strip healthcare away from millions of people. That has left the senator to defend a bill that many Republicans didn't want to become law: the "skinny" repeal bill that eliminated only Obamacare's individual and employer mandates and some of its taxes. Some Nevada political observers were confused by Heller's decision to vote for the skinny bill after voting down straight repeal and the Senate bill to repeal and replace Obamacare. "If you were going to write a guidebook on how not to handle an issue, Dean Heller has got one for you," said Jon Ralston, longtime political reporter and editor of the Nevada Independent, on KNPR's State of Nevada last month. "He could be a best-selling author: Don't do this.'"

Tom Price declares national emergency after Harvey: The Health and Human Services secretary declared a public health emergency in Texas as Hurricane Harvey made landfall Friday night. "HHS is taking the necessary measures and has mobilized the resources to provide immediate assistance to those affected by Hurricane Harvey," Price said in a statement posted to HHS.gov. Price has given the Centers for Medicare and Medicaid Services, Medicare beneficiaries and their healthcare providers more flexibility in meeting emergency healthcare needs.

Texas asks insurers to give flexibility to Harvey victims: Texas insurance regulator is calling on insurers to waive any penalties for people who get healthcare outside of their network.

The states insurance commissioner said Saturday that the storm could force enrollees to evacuate their residences and location where they normally get healthcare. Insurers should waive any penalties for going out of network as a result of the disaster, the state said. Harvey brought torrential rain and floods that have forced tens of thousands of people in Texas to flee their homes.

FDA cracks down on stem cell clinic: The Food and Drug Administration warned a Florida stem cell clinic for peddling unauthorized stem cell products. The warning letter issued Monday to U.S. Stem Cell Clinic in Sunrise, Fla., is part of a larger crackdown on fraudulent stem cell clinics. The warning letter from FDA Commissioner Scott Gottlieb found that the clinic manufactured products in unsanitary conditions and marketed products that werent reviewed or approved by the agency.

RUNDOWN

Axios What could happen next on Obamacares taxes

Washington Post In Trump states, Sanders tries to push Democrats to the left on healthcare

Bloomberg The FDAs consumer protection warnings are falling under Trump

Forbes Employer plans join Obamacare in narrowing doctor networks for 2018

STAT News Peter Thiel runs offshore test of herpes vaccine, bypassing U.S. safety regulations

New York Times Trumps threats on health law hide an upside: Gains made by some insurers

LA Times The debate over single payer isnt going away in California. Heres why

Minneapolis Star Tribune Measles outbreak was costly, state health officials say

Miami Herald Woman eats out of dumpster so her husband can afford healthcare

MONDAY , Aug. 28

Aug. 28-31. Paralyzed Veterans of America Annual Summit. Details.

WEDNESDAY, Aug. 30

1 p.m. Rural Health Information Hub, CDC and National Cancer Institute hold webinar on rural cancer. Details.

THURSDAY, AUG. 31

7 p.m., Rockville, Md. Maryland Sen. Ben Cardin holds a town hall to discuss healthcare at Johns Hopkins Universitys Rockville, Md., campus. 9601 Medical Drive. events2@cardin.senate.gov

WEDNESDAY, SEPT. 6

10 a.m. 430 Dirksen. The Senate Health, Education, Labor and Pensions Committee will hold a hearing on stabilizing the Obamacare exchanges. State insurance commissioners will testify.help.senate.gov/hearings/stabilizing-premiums-and-helping-individuals-in-the-individual-insurance-market-for-2018-state-insurance-commissioners

THURSDAY, SEPT. 7

9 a.m. 430 Dirksen. The Senate Health, Education, Labor and Pensions Committee will hold a second hearing on stabilizing the Obamacare exchanges, with several governors testifying. help.senate.gov/hearings/stabilizing-premiums-and-helping-individuals-in-the-individual-insurance-market-for-2018-governors

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Daily on Healthcare: Lack of bare counties doesn't solve Obamacare's problems - Washington Examiner

How a UCSF study could change the lives of babies in the womb and maybe help California’s stem cell program in … – San Francisco Business Times

Stem Cell Clinic | Posted by admin
Aug 25 2017
How a UCSF study could change the lives of babies in the womb and maybe help California's stem cell program in ...
San Francisco Business Times
The world's first in-utero blood stem cell transplant, soon to be performed at the University of California, San Francisco, could point the way toward pre-birth cures for a range of blood diseases, such as sickle cell disease. It's also the sort of ...

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How a UCSF study could change the lives of babies in the womb and maybe help California's stem cell program in ... - San Francisco Business Times

Joint Preservation vs. Replacement: What’s Your Best Option? – Health Essentials from Cleveland Clinic (blog)

Stem Cell Clinic | Posted by admin
Aug 23 2017

If you have recurring or chronic joint pain, you may think joint replacement surgery is your only option for relief. However, you may want to explore several less invasive options first to helpmaintain mobility as you age.

Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services. Policy

Withmillions of baby boomers in the United States wanting to stay active into their 60s, 70s and beyond, much recent research has focused on joint health and replacement technology.

Experiencingjoint pain doesnt automatically mean that you should have a joint replacement. Joint replacement surgery is generally performed for late stages of degenerative arthritis (also called osteoarthritis), after other options have failed. Most causes for hip pain can be treated with far less invasive options.

So howdo you know your arthritis or other joint damage needs attention? In general, you should see a doctor if your joint pain limits your activities for more than three days without improvement, or you have recurring episodes of the same pain over several weeks or months.

Read on to find out where you fall on the continuum of joint care.

You can damage a joint suddenly. Orjoint damage may come on gradually, bothering you periodically at first and becoming more painful over time.

The causesofjoint pain may include:

Most joint causes for joint pain never require surgery. However, even in the case of osteoarthritis, surgery is not the first choice. Whatever the cause, youll want to preserve your joints for as long as you can.

This is particularly true if you are a younger, active person.

Joint replacement has gotten much safer and faster to recover from. You may leavethe hospital just a couple of days after surgery, but these are serious operations that are not to be undertaken lightly, says orthopedic surgeonAnthony Miniaci, MD.

Joint replacementparts last longer than they used to. But they are mechanical and subject to loosening, stiffness, complications and infection. These problems may lead to follow-up surgeries down the road.

Most people now live into their 80s. Many of the next generation will live to be older than 100, Dr. Miniaci says. If someone in their 50s is very active and has knee or hip joint replacement, they may need one or two more operations in their lifetime, so we try to avoid it until later if possible.

The goal of preservation is to prevent injury, reduce inflammation and preserve cartilage, Dr. Miniaci says. These factors figure in when your physician weighs your options:

Some joint preservation procedures are newer and considered experimental, Dr. Miniaci says. Physicians have used other preservation techniques for decades. Options, he says, include:

If youve unsuccessfully attempted conservative treatment or if damage to the cartilage or bone is beyond repair, remember that joint replacement is proven to be safe and highly effective in the right patient. This is still often is your best option.

This surgery can dramatically relieve your pain and improve your joints function. However, there are always potential risks and complications with surgery.

Talk with your doctor about the best options and long-term strategies for you. Preserving your joints and your activities and lifestyle is the basis for the partnership that is best for you.

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Joint Preservation vs. Replacement: What's Your Best Option? - Health Essentials from Cleveland Clinic (blog)

Stem Cell Study for Dogs – MyWabashValley

Stem Cell Clinic | Posted by admin
Aug 23 2017

Terre Haute, IN - Maggie Mae and her owner Robert Howrey come from Paris, Illinois for a check-up at the Wabash Valley Animal Hospital in Terre Haute. She doesn't act like it, but Maggie Mae is a senior citizen and she has problems with her joints.

"Arthritis is a common condition in older dogs and we like to help them out," said Dr. Andrew Pickering, veterinarian.

A California company called "Animal Cell Therapies" has enlisted veterinarians all across the country to participate in a study of using stem cells for dogs with arthritis. Some of the canines in the study receive an injection of stem cells, others get just a saline solution.

Local vet, Doctor Andrew Pickering doesn't know which injections Maggie Mae is getting, but she no longer limps, and he's encouraged by the results.

"We're hoping this particular type of treatment will cure the condition for a long period of time so we don't have to keep giving the dog medication all the time," said Pickering.

Howrey says it's almost like having a new dog. "It's been about six weeks, so now she's back doing normal activities, she runs, she chases squirrels "

The research will continue for several more months. And the local clinic is still looking for owners who would like to get their pets involved. Study participation is free for dogs that qualify. Plus, even the animals that receive the saline injections will be able to get the stem cell treatment once the study is complete.

Click here to connect with the study web page

Click here to connect with the Wabash Valley Animal Hospital

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Stem Cell Study for Dogs - MyWabashValley

Bio-inspired Materials Give Boost to Regenerative Medicine – Bioscience Technology

Stem Cell Clinic | Posted by admin
Aug 22 2017

What if one day, we could teach our bodies to self-heal like a lizards tail, and make severe injury or disease no more threatening than a paper cut?

Or heal tissues by coaxing cells to multiply, repair or replace damaged regions in loved ones whose lives have been ravaged by stroke, Alzheimers or Parkinsons disease?

Such is the vision, promise and excitement in the burgeoning field of regenerative medicine, now a major ASU initiative to boost 21st-century medical research discoveries.

ASU Biodesign Institute researcher Nick Stephanopoulos is one of several rising stars in regenerative medicine. In 2015, Stephanopoulos, along with Alex Green and Jeremy Mills, were recruited to the Biodesign Institutes Center for Molecular Design and Biomimetics (CMDB), directed by Hao Yan, a world-recognized leader in nanotechnology.

One of the things that that attracted me most to the ASU and the Biodesign CMDB was Haos vision to build a group of researchers that use biological molecules and design principles to make new materials that can mimic, and one day surpass, the most complex functions of biology, Stephanopoulos said.

I have always been fascinated by using biological building blocks like proteins, peptides and DNA to construct self-assembled structures, devices and materials, and the interdisciplinary and highly collaborative team in the CMDB is the ideal place to put this vision into practice.

Yans research center uses DNA and other basic building blocks to build their nanotechnology structures only at a scale 1,000 times smaller than the width of a human hair.

Theyve already used nanotechnology to build containers to specially deliver drugs to tissues, build robots to navigate a maze or nanowires for electronics.

To build a manufacturing industry at that tiny scale, their bricks and mortar use a colorful assortment of molecular Legos. Just combine the ingredients, and these building blocks can self-assemble in a seemingly infinite number of ways only limited by the laws of chemistry and physics and the creative imaginations of these budding nano-architects.

Learning from nature

The goal of the Center for Molecular Design and Biomimetics is to usenatures design rulesas an inspiration in advancing biomedical, energy and electronics innovation throughself-assembling moleculesto create intelligent materials for better component control and for synthesis intohigher-order systems, said Yan, who also holds the Milton Glick Chair in Chemistry and Biochemistry.

Prior to joining ASU, Stephanopoulos trained with experts in biological nanomaterials, obtaining his doctorate with the University of California Berkeleys Matthew Francis, and completed postdoctoral studies with Samuel Stupp at Northwestern University. At Northwestern, he was part of a team that developed a new category of quilt-like, self-assembling peptide and peptide-DNA biomaterials for regenerative medicine, with an emphasis in neural tissue engineering.

Weve learned from nature many of the rules behind materials that can self-assemble. Some of the most elegant complex and adaptable examples of self-assembly are found in biological systems, Stephanopoulos said.

Because they are built from the ground-up using molecules found in nature, these materials are also biocompatible and biodegradable, opening up brand-new vistas for regenerative medicine.

Stephanopoulos tool kit includes using proteins, peptides, lipids and nucleic acids like DNA that have a rich biological lexicon of self-assembly.

DNA possesses great potential for the construction of self-assembled biomaterials due to its highly programmable nature; any two strands of DNA can be coaxed to assemble to make nanoscale constructs and devices with exquisite precision and complexity, Stephanopoulos said.

Proof all in the design

During his time at Northwestern, Stephanopoulos worked on a number of projects and developed proof-of-concept technologies for spinal cord injury, bone regeneration and nanomaterials to guide stem cell differentiation.

Now, more recently, in a new studyin Nature Communications, Stephanopoulos and his colleague Ronit Freeman in the Stupp laboratory successfully demonstrated the ability to dynamically control the environment around stem cells, to guide their behavior in new and powerful ways.

In the new technology, materials are first chemically decorated with different strands of DNA, each with a unique code for a different signal to cells.

To activate signals within the cells, soluble molecules containing complementary DNA strands are coupled to short protein fragments, called peptides, and added to the material to create DNA double helices displaying the signal.

By adding a few drops of the DNA-peptide mixture, the material effectively gives a green light to stem cells to reproduce and generate more cells. In order to dynamically tune the signal presentation, the surface is exposed to a soluble single-stranded DNA molecule designed to grab the signal-containing strand of the duplex and form a new DNA double helix, displacing the old signal from the surface.

This new duplex can then be washed away, turning the signal off. To turn the signal back on, all that is needed is to now introduce a new copy of single-stranded DNA bearing a signal that will reattach to the materials surface.

One of the findings of this work is the possibility of using the synthetic material to signal neural stem cells to proliferate, then at a specific time selected by the scientist, trigger their differentiation into neurons for a while, before returning the stem cells to a proliferative state on demand.

One potential use of the new technology to manipulate cells could help cure a patient with neurodegenerative conditions like Parkinsons disease.

The patients own skin cells could be converted to stem cells using existing techniques. The new technology could help expand the newly converted stem cells back in the lab and then direct their growth into specific dopamine-producing neurons before transplantation back to the patient.

People would love to have cell therapies that utilize stem cells derived from their own bodies to regenerate tissue, Stupp said. In principle, this will eventually be possible, but one needs procedures that are effective at expanding and differentiating cells in order to do so. Our technology does that.

In the future, it might be possible to perform this process entirely within the body. The stem cells would be implanted in the clinic, encapsulated in the type of material described in the new work, and injected into a particular spot. Then the soluble peptide-DNA molecules would be given to the patient to bind to the material and manipulate the proliferation and differentiation of transplanted cells.

Scaling the barriers

One of the future challenges in this area will be to develop materials that can respond better to external stimuli and reconfigure their physical or chemical properties accordingly.

Biological systems are complex, and treating injury or disease will in many cases necessitate a material that can mimic the complex spatiotemporal dynamics of the tissues they are used to treat, Stephanopoulos said.

It is likely that hybrid systems that combine multiple chemical elements will be necessary; some components may provide structure, others biological signaling and yet others a switchable element to imbue dynamic ability to the material.

A second challenge, and opportunity, for regenerative medicine lies in creating nanostructures that can organize material across multiple length scales. Biological systems themselves are hierarchically organized: from molecules to cells to tissues, and up to entire organisms.

Consider that for all of us, life starts simple, with just a single cell. By the time we reach adulthood, every adult human body is its own universe of cells, with recent estimates of 37 trillion or so. The human brain alone has 100 billion cells or about the same number of cells as stars in the Milky Way galaxy.

But over the course of a life, or by disease, whole constellations of cells are lost due to the ravages of time or the genetic blueprints going awry.

Collaborative DNA

To overcome these obstacles, much more research funding and recruitment of additional talent to ASU will be needed to build the necessary regenerative medicine workforce.

Last year, Stephanopoulos research received a boost with funding from the U.S. Air Forces Young Investigator Research Program (YIP).

The Air Force Office of Scientific ResearchYIP award will facilitate Nicks research agenda in this direction, and is a significant recognition of his creativity and track record at the early stage of his careers, Yan said.

Theyll need this and more to meet the ultimate challenge in the development of self-assembled biomaterials and translation to clinical applications.

Buoyed by the funding, during the next research steps, Stephanopoulos wants to further expand horizons with collaborations from other ASU colleagues to take his research teams efforts one step closer to the clinic.

ASU and the Biodesign Institute also offer world-class researchers in engineering, physics and biology for collaborations, not to mention close ties with the Mayo Clinic or a number of Phoenix-area institutes so we can translate our materials to medically relevant applications, Stephanopoulos said.

There is growing recognition that regenerative medicine in the Valley could be a win-win for the area, in delivering new cures to patients and building, person by person, a brand-new medicinal manufacturing industry.

Stephanopoulos recent research was carried out at Stupps Northwesterns Simpson Querrey Institute for BioNanotechnology. The National Institute of Dental and Craniofacial Research of the National Institutes of Health (grant 5R01DE015920) provided funding for biological experiments, and the U.S. Department of Energy, Office of Science, Basic Energy Sciences provided funding for the development of the new materials (grants DE-FG01-00ER45810 and DE-SC0000989 supporting an Energy Frontiers Research Center on Bio-Inspired Energy Science (CBES)).

The paper is titled Instructing cells with programmable peptide DNA hybrids. Samuel I. Stupp is the senior author of the paper, and post-doctoral fellows Ronit Freeman and Nicholas Stephanopoulos are primary authors.

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Bio-inspired Materials Give Boost to Regenerative Medicine - Bioscience Technology

Fraud Alert! Unproven Stem Cell Use Prompts International Call to Action – American Council on Science and Health

Stem Cell Clinic | Posted by admin
Aug 20 2017

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

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

When greed trumps science, we all lose.

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

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

Heres the deal with stem cells

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

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

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

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

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

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

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

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

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

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

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

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

In conclusion

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

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

Friends come together for benefit concert for Joni Eickhoff – Grand Island Independent

Stem Cell Clinic | Posted by admin
Aug 16 2017

When Dianne Schneider found out her friend and fellow parishioner Joni Eickhoff was trying to raise money to pay for an unconventional medical treatment for her pulmonary cystic fibrosis, she knew what she had to do perform a concert.

Schneider, who is a longtime music minister at St. Marys Cathedral, didnt think she would ever say that. But a few years ago, Eickhoff encouraged Schneider to record a CD of her music with fellow musician Claudette Sekutera. The CD of contemporary Christian music was recorded in 2012 and half of the funds raised by the sale of the CD have gone to benefit St. Marys Cathedral.

She would always come up and say how beautiful the music was and she was the one who always told me I should record a CD, Schneider remembered. She just wanted so much for me to do a concert back then, but I didnt really want to. I dont know if it was that I didnt want to draw the attention to myself or that deep down I didnt think anyone would come.

When Schneider saw the flyer in church asking for donations for Eickhoffs GoFundMe account, she thought differently.

I kept thinking about it and thought that this is the time for a concert because now it has a purpose, she said.

The benefit concert is scheduled for 3 to 4:30 p.m. Sunday at St. Marys Cathedral. Besides Sekutera, Schneider will perform with Amy and Andy Schneider, Jeanne Allen and Sue Stueben. There is no charge to attend, but a freewill offering will be accepted. A group from Woodmens Insurance has offered to match the proceeds. Schneider will also be selling her CD Gratitude for $10, with half of those proceeds going to Eickhoff as well.

Eickhoff was more than just a little surprised by Schneiders offer.

You talk about tears that come down, Eickhoff said. Shes just one of a kind. Shes my guardian angel.

Pulmonary cystic fibrosis is an inherited disease that causes thickened mucus to block airways, making it difficult to breathe.

Diagnosed in 2015, Joni had all but exhausted conventional medical treatments when she and her husband, Ramon, learned about stem cell treatments at a pulmonary clinic in Dallas, Texas.

The cost was prohibitive, though, as the procedure was not covered by Medicare or insurance. The Eickhoff family set up a GoFundMe account to raise $11,000, which included the cost of transportation to and from the clinic. They posted a flyer at St. Marys Cathedral and shortly after that, Eickhoffs husband was approached by another parishioner who offered to cover the entire cost.

The Eickhoffs accepted the offer on the condition that they be able to pay back the gift. The donor agreed and Joni underwent the procedure on April 20 and has been steadily improving. Since the treatment, her husband said, she has gone from being able to take 56 steps without oxygen to 101 steps without oxygen.

Each time we do a walk test without oxygen, her recovery time has gone to five or six minutes, where before it was only a couple of minutes, he said.

It was very successful, Joni said. All I did was sit in a chair.

Eickhoff said drawing the blood at the clinic was a six-hour procedure over the course of two days, three hours each day. When she asked her doctor when she could expect to see results, the doctor told her three to six months.

Im just doing so good, she said, after just a little over three months. Of course, when I talk, it takes a lot of air.

Eickhoff and her husband have been so encouraged by her results, they want to spread the word about stem cell treatments. Ramon said there are five similar clinics in the United States and they advertise an 82 to 83 percent success rate.

If you can do the stem cell treatment, you can be off oxygen, Joni said. There are 150,000 people that are dying that dont have to.

Colleen Gallion is the associate editor of the West Nebraska Register.

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Friends come together for benefit concert for Joni Eickhoff - Grand Island Independent

‘Unexpected fountain of youth’ found in cardiac stem cells, researcher says – FOX31 Denver

Stem Cell Clinic | Posted by admin
Aug 16 2017

Cardiac stem cells derived from young hearts helped reverse the signs of aging when directly injected into the old hearts of elderly rats, astudypublished Monday in the European Heart Journal demonstrated.

The old rats appeared newly invigorated after receiving their injections. As hoped, the cardiac stem cells improved heart function yet also provided additional benefits. The rats fur fur, shaved for surgery, grew back more quickly than expected, and their chromosomal telomeres, which commonly shrink with age, lengthened.

The old rats receiving the cardiac stem cells also had increased stamina overall, exercising more than before the infusion.

Its extremely exciting, said Dr. Eduardo Marbn, primary investigator on the research and director of the Cedars-Sinai Heart Institute. Witnessing the systemic rejuvenating effects, he said, its kind of like an unexpected fountain of youth.

Weve been studying new forms of cell therapy for the heart for some 12 years now, Marbn said.

Some of this research has focused on cardiosphere-derived cells.

Theyre progenitor cells from the heart itself, Marbn said. Progenitor cells are generated from stem cells and share some, but not all, of the same properties. For instance, they can differentiate into more than one kind of cell like stem cells, but unlike stem cells, progenitor cells cannot divide and reproduce indefinitely.

From hisown previous research, Marbn discovered that cardiosphere-derived cells promote the healing of the heart after a condition known as heart failure with preserved ejection fraction, which affects more than 50% of all heart failure patients.

Since heart failure with preserved ejection fraction is similar to aging, Marbn decided to experiment on old rats, ones that suffered from a type of heart problem thats very typical of what we find in older human beings: The hearts stiff, and it doesnt relax right, and it causes fluid to back up some, Marbn explained.

He and his team injected cardiosphere-derived cells from newborn rats into the hearts of 22-month-old rats thats elderly for a rat. Similar old rats received a placebo injection of saline solution. Then, Marbn and his team compared both groups to young rats that were 4 months old. After a month, they compared the rats again.

Even though the cells were injected into the heart, their effects were noticeable throughout the body, Marbn said

The animals could exercise further than they could before by about 20%, and one of the most striking things, especially for me (because Im kind of losing my hair) the animals regrew their fur a lot better after theyd gotten cells compared with the placebo rats, Marbn said.

The rats that received cardiosphere-derived cells also experienced improved heart function and showed longer heart cell telomeres.

The working hypothesis is that the cells secrete exosomes, tiny vesicles that contain a lot of nucleic acids, things like RNA, that can change patterns of the way the tissue responds to injury and the way genes are expressed in the tissue, Marbn said.

It is the exosomes that act on the heart and make it better as well as mediating long-distance effects on exercise capacity and hair regrowth, he explained.

Looking to the future, Marbn said hes begun to explore delivering the cardiac stem cells intravenously in a simple infusion instead of injecting them directly into the heart, which would be a complex procedure for a human patient and seeing whether the same beneficial effects occur.

Dr. Gary Gerstenblith, a professor of medicine in the cardiology division of Johns Hopkins Medicine, said the new study is very comprehensive.

Striking benefits are demonstrated not only from a cardiac perspective but across multiple organ systems, said Gerstenblith, who did not contribute to the new research. The results suggest that stem cell therapies should be studied as an additional therapeutic option in the treatment of cardiac and other diseases common in the elderly.

Todd Herron, director of the University of Michigan Frankel Cardiovascular Centers Cardiovascular Regeneration Core Laboratory, said Marbn, with his previous work with cardiac stem cells, has led the field in this area.

The novelty of this bit of work is, they started to look at more precise molecular mechanisms to explain the phenomenon theyve seen in the past, said Herron, who played no role in the new research.

One strength of the approach here is that the researchers have taken cells from the organ that they want to rejuvenate, so that makes it likely that the cells stay there in that tissue, Herron said.

He believes that more extensive study, beginning with larger animals and including long-term followup, is needed before this technique could be used in humans.

We need to make sure theres no harm being done, Herron said, adding that extending the lifetime and improving quality of life amounts to a tradeoff between the potential risk and the potential good that can be done.

Capicor, the company that grows these special cells, is focused solely on therapies for muscular dystrophy and heart failure with ongoing clinical trials involving human patients, Marbn said.

Capicor hasnt announced any plans to do studies in aging, but the possibility exists.

After all, the cells have been proven completely safe in over 100 human patients, so it would be possible to fast-track them into the clinic, Marbn explained: I cant tell you that there are any plans to do that, but it could easily be done from a safety viewpoint.

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'Unexpected fountain of youth' found in cardiac stem cells, researcher says - FOX31 Denver