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Xeno-free Cell Culture Medium for Regenerative Medicine Research – Technology Networks

Stem cells and genome editing offer exciting opportunities within regenerative medicine. However, any clinical application of stem cells requires strict regulation to ensure that the cells are not exposed to animal derived products.

StemFit Basic02 is a xeno-free, defined medium for human pluripotent stem cell (hiPSC) culture that offers an effective solution for regenerative medicine research. This medium has been proven to effectively maintain Induced Pluripotent Stem (iPS) and Embryonic Stem (ES) cells under feeder-free conditions, during the reprogramming, expansion and differentiation phases of stem cell culture.

Specially formulated to enhance single cell expansion in the cloning step of stem cell genome editing, StemFit Basic02 offers superior and stable growth performance, high colony forming efficiency and robust scalable cell expansion. This ensures high karyotype stability over long periods and hence reproducible culture conditions.

StemFit cell culture media has been independently evaluated by CGT Catapult, an independent centre of excellence helping advance the UK cell and gene therapy industry. In these tests, StemFit not only delivered higher cell proliferation, but also showed characteristics such as homogeneity of gene expression compared with iPS cells cultured with 4 other media without any chromosomal abnormalities.

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Xeno-free Cell Culture Medium for Regenerative Medicine Research - Technology Networks

Does Immune System Hold Clues to Preterm Births? – Montana Standard

FRIDAY, Sept. 1, 2017 (HealthDay News) -- By learning more about the immune system changes that occur during pregnancy, scientists hope they can someday predict if babies will be born prematurely.

"Pregnancy is a unique immunological state. We found that the timing of immune system changes follows a precise and predictable pattern in normal pregnancy," said study senior author Dr. Brice Gaudilliere. He's an assistant professor of anesthesiology, perioperative and pain medicine at Stanford University School of Medicine in California.

If scientists can identify immune-system changes predicting premature birth, they say they might eventually develop a blood test to detect it.

"Ultimately, we want to be able to ask, 'Does your immune clock of pregnancy run too slow or too fast?'" Gaudilliere said in a university news release.

Nearly 10 percent of U.S. infants are born three or more weeks early. Currently, doctors have no reliable way to predict which babies will be born prematurely.

For the study, the researchers collected blood samples from 18 women who had full-term pregnancies. The women gave one sample during each trimester and another six weeks after childbirth. The researchers used samples from another group of 10 women who also had full-term pregnancies to verify the findings.

Using a technique called mass cytometry, the researchers simultaneously measured up to 50 properties of each immune cell in the blood samples. The investigators counted the types of immune cells, determined which signaling pathways were most active in each cell, and assessed how the cells reacted when exposed to compounds that mimic bacterial or viral infection.

The research team then used advanced statistical modeling to document the immune system changes occurring throughout pregnancy. (These adjustments keep the mother's body from rejecting the unborn baby.)

"This algorithm is telling us how specific immune cell types are experiencing pregnancy," Gaudilliere said.

The study confirmed that natural killer cells and certain white blood cells have enhanced action during pregnancy. The researchers also found that a signaling pathway among helper T-cells increases on a precise schedule.

"It's really exciting that an immunological clock of pregnancy exists," said study lead author Nima Aghaeepour, an instructor in anesthesiology, perioperative and pain medicine.

"Now that we have a reference for normal development of the immune system throughout pregnancy, we can use that as a baseline for future studies to understand when someone's immune system is not adapting to pregnancy the way we would expect," Aghaeepour added.

The study results were published Sept. 1 in Science Immunology.

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Does Immune System Hold Clues to Preterm Births? - Montana Standard

New ‘hit-and-run’ gene editing tool temporarily rewrites genetics to treat cancer and HIV – GeekWire

Nanoparticles (orange) deliver temporary gene therapy to immune cells (blue) to give them disease-fighting tools. (Fred Hutch Illustration / Kimberly Carney)

CAR T immunotherapies are all the rage in the medical community, reprogramming a patients immune system to fight cancer. For some patients, theyve produced near-miraculous recoveries, and they could be a huge breakthrough in cancer treatment.

The business community is taking note as well: Kite Pharma, a biotech company developing these therapies, announced a deal to be acquired for $11.9 billion on Monday, sending stock prices of Seattle immunotherapy developer Juno Therapeuticsskyrocketing.

But there are still giant pitfalls to using the therapies on a large scale because they are incredibly complex and expensive to produce. Researchers from Seattles Fred Hutchinson Cancer Research Center are taking the problem head-on with new hit-and-run gene editing technology.

In a study published Wednesday in the journal Nature Communications, researchers led by Dr.Matthias Stephan reported they have developed a nanoparticle delivery system that can temporarily alter cells so they are able to fight cancer and other diseases.

The best part? The treatment is a powder that just needs to be mixed with water to activate and even better, it could be an essential breakthrough in making cutting-edge medical technology affordable for patients.

Stephan told GeekWire in a previous piece on the technology that his goal is to make immunotherapy so easy to access that it replaces chemotherapy as the front-line treatment for cancer.

What I envision is like the Walgreens flu shot scenario, or you go to your doctor and you get hepatitis B shot, he said at the time. You go there every Friday, and thats it.

We realized in order to outcompete chemotherapy, we have to design something that is at least as affordable and can be manufactured at large scale by one biotech company and shipped out to local infusion centers, Stephan said. At the moment, CAR T cell therapies must be made individually for each patient in specialized labs.

Heres how the new tech works: The nanoparticles designed by Stephan and his team act like shipping containers for bundles of mRNA, the molecules that tell cells how to build disease-fighting proteins. The nanoparticles also have molecules attached to the outside to help them find the right kind of cells, like a shipping label on a package.

When the mRNA is delivered to the cell, it prompts the cell to grow disease-fighting features, like the chimeric antigen receptor in CAR T cells that help them identify and kill cancer.Researchers said the technology could potentially be used to develop treatments for HIV, diabetes and other immune-related diseases.

In the short run, the tech could help researchers discover new treatments and therapies in the lab. It could one day be used in hospitals and clinics around the world, but will first need to undergo extensive clinical trials to ensure the tech is effective and safe to use in humans.

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New 'hit-and-run' gene editing tool temporarily rewrites genetics to treat cancer and HIV - GeekWire

How one California county is fighting high-priced surgeries – Los Angeles Times

Retiree Leslie Robinson-Stone and her husband enjoyed a weeklong, all-expenses-paid trip to a luxury resort all thanks to the county she worked for.

The couple also received more than a thousand dollars in spending money and a personal concierge, who attended to their every need. For Santa Barbara County, it was money well spent: Sending Robinson-Stone 250 miles away for knee replacement surgery near San Diego saved the government $30,000.

The only difference between our two hospitals is one is expensive and the other is exorbitant, said Andreas Pyper, assistant director of human resources for Santa Barbara County, referring to the local options.

After years of hospital industry consolidation, frustration with sky-high hospital bills and a lack of local competition is common to many employers and consumers across the country. Fed up with wildly different price tags for routine operations, some private employers are steering patients they insure to top-performing providers who offer bargain prices. Santa Barbara County, with about 4,000 employees, is among a handful of public entities to join them.

The county has saved nearly 50% on four surgery cases since starting its out-of-town program last year, officials said. The program is voluntary for covered employees.

At a Scripps Health hospital in the San Diego area, the county paid $61,600 for a spinal fusion surgery that would have cost more than twice as much locally. It avoided two other operations altogether after patients went outside the area for second opinions.

Typically, employers are seeking deals through bundled payments in which one fixed price covers tests, physician fees and hospital charges. And if complications arise, providers are on the hook financially. Medicare began experimenting with this method during the Obama administration.

Santa Barbara County is among about 400 employers on the West Coast working with Carrum Health, a South San Francisco, Calif., start-up that negotiates bundled prices and chooses surgeons based on data on complications and readmissions.

Not all surgeons are equal. We dont want to give Scripps a blank check. That defeats the whole purpose, said Sachin Jain, Carrums chief executive.

Santa Barbara officials try to persuade workers and their family members to participate in its program by waiving co-pays and deductibles. The county pays about $2,700 in travel costs and still comes out way ahead.

If that doesnt speak to the inefficiencies in our healthcare system, I dont know what does, Pyper said. Its almost like buying a Toyota Corolla for $50,000 and then going to San Diego to buy the same Corolla for $16,000. How long would the more expensive Toyota dealership last?

Even as more employers and insurers embrace bundled payments, the Trump administration is applying the brakes.

In August, Medicare officials proposed canceling mandatory bundled payments for certain surgeries and scaling back the program for knee and hip replacements. Health and Human Services Secretary Tom Price, when he was still a member of Congress, accused Medicare of overstepping federal authority and interfering in the doctor-patient relationship. Hospital trade groups have voiced similar objections.

That leaves some health-policy experts dismayed.

These bundled payments put pressure on medical providers and the savings are astonishing, said Bob Kocher, a former health official in the Obama administration and now a partner in the venture capital firm Venrock.

Santa Barbara County officials said they had no choice after seeing their medical costs soar by 15% in each of the last two years. Like many local governments, it has an older workforce prone to chronic illness, blocked arteries and bum knees.

But health costs run higher than the state average in this scenic coastal county of about 450,000 people, according to data from Oakland-based Integrated Healthcare Assn. By one measure, the average health insurance premium in the individual market runs $660 a month in Santa Barbara, 27% higher than in Los Angeles.

Heidi de Marco / Kaiser Health News

Maya Barraza is Santa Barbara Countys manager for employee benefits.

Maya Barraza is Santa Barbara Countys manager for employee benefits. (Heidi de Marco / Kaiser Health News)

Still, Maya Barraza, the countys manager for employee benefits and rewards, knew the program would be a hard sell to workers. You dont want to be away from your family and whats familiar, she said.

Cottage Health, the countys largest health system, says it wants to keep patients in town for treatment and follow-up care.

Established in 1891, its grown from a single hospital to more than 500 beds across three hospitals, and annual revenue hit $746 million last year.

Valet attendants greet visitors at two entrances outside the groups white, Spanish-style hospital in the city of Santa Barbara. In the main lobby, the names of wealthy donors are splashed across one wall, including billionaire investor and Donald Trump confidant Thomas Barrack.

We are continually looking at reducing costs and improving quality, said Cottage Health spokeswoman Maria Zate. Cottage Health has some of the top surgeons in California.

Sixty miles north in Santa Maria, the states largest hospital chain, Dignity Health, offers another option: Marian Regional Medical Center.

Both Cottage and Dignity hospitals in Santa Barbara County have quality scores of fair to excellent for joint replacements, spinal procedures and coronary bypass surgeries, according to three years of Medicare data analyzed by research firm Mpirica Health.

Dignity Health didnt respond to requests for comment.

Carrum tries to help employers like Santa Barbara County find more affordable options. It has struck bundled price deals for various procedures with Scripps hospitals in the San Diego area, Stanford Health Care in the Bay Area and Swedish Medical Center in Seattle, part of the Providence Health chain.

Some companies have gone so far as to send patients overseas for cheaper care, but most employers favor a more regional approach, experts say. Workers still rely on local physicians for follow-up care.

For some hospitals, there are advantages in offering deep discounts: They get patients they otherwise would never see and are paid in full right after the patient is discharged, avoiding the onerous billing and collections process.

They also have the financial capacity to offer such sharply reduced prices.

Michael Bark, assistant vice president of payer relations at Scripps Health, said most hospitals significantly mark up their commercial rates for orthopedic procedures and cardiac surgeries to compensate for lower government reimbursements.

There are immense profit margins built into those cases, Bark said.

Robinson-Stone, a former county sheriffs deputy and a computer support specialist, was initially wary of traveling for her surgery. But the 62-year-old had ongoing pain that kept her from biking, walking her dogs and tending to her fruit trees. Medication and cortisone shots didnt work, and she had no ties to local surgeons. So she signed up online and was given a choice of six orthopedic surgeons at Scripps Green Hospital in La Jolla.

In June 2016, she and her husband, Frank Stone, checked in at the Estancia La Jolla Hotel and Spa.

Robinson-Stone met the surgeon on a Wednesday, had the operation the next day and returned to her hotel room by Saturday. She continued physical therapy at the hotel and returned to the hospital a few days later to have the staples removed.

She was back on her bike within two months and eventually lost about 20 pounds.

I just celebrated one year from surgery, she said, and Im a happy camper.

Chad Terhune is a senior correspondent for Kaiser Health News, an editorially independent publication of the Kaiser Family Foundation. Heidi DeMarco contributed to this story.

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Hailing a breakthrough in fighting cancer, FDA approves gene therapy that functions as a living drug

FDA cracks down on clinics selling unproven stem cell 'therapies'

Gilead is buying Kite Pharma, a cancer-fighting Santa Monica biotech firm, for $11.9 billion

Knocking on doors, climbing through fences: How L.A. County's health investigators are out trying to stop syphilis

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How one California county is fighting high-priced surgeries - Los Angeles Times

Cambridge Enterprise and Qkine to drive stem cell and regenerative medicine research – Business Weekly

Cambridge Enterprise, the commercialisation arm of the University of Cambridge, and specialist growth factor manufacturer Qkine Ltd have signed a key licensing deal for Activin A production technology.

Qkine is a recent spin-out from the university. The newly-licensed methodology, which was developed by one of the companys founders Dr Marko Hyvnen, will be used to manufacture proteins utilised for control of stem cell growth and differentiation.

Growth factors are proteins that transmit signals from one cell to another in higher organisms, orchestrating organisation of the developing embryo and regulating biological functions and repair processes in adults. Activin A, and others from its family of proteins, are essential ingredients used by stem cell scientists to mimic the environment in the human body. They allow carefully synchronised messages to be sent to stem cells, effectively telling them to turn into the desired cell type.

With exponential growth in the study of stem cells for disease modelling, drug screening, precision medicine and development of new therapeutics the need for high quality reagents for fine control of stem cell cultures is ever increasing.

Growing demand for Activin A and related growth factors and an opportunity to use protein engineering techniques to optimise these growth factors motivated Hyvnen and co-founder Dr Catherine Onley, a translational scientist, to start Qkine. Its mission is to produce high quality bioactive proteins for stem cell researchers and the regenerative medicine industry.

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

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

Qkine co-founders Dr Marko Hyvnen (picture courtesy - Chris Green) and Dr Catherine Onley (picture courtesy Suzi Ovens)

Qkine was awarded a Cambridge Enterprise Pathfinder investment in December 2016 to facilitate the founding of the company. Qkine started operation as an embedded company at the Department of Biochemistry in April 2017.

Dr Iain Thomas, head of Life Sciences at Cambridge Enterprise, said: Qkine is a great example of how opportunities are incubated in the University until the commercial time is right.

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

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Cambridge Enterprise and Qkine to drive stem cell and regenerative medicine research - Business Weekly

Doubts raised about CRISPR gene-editing study in human embryos – Nature.com

Doubts have surfaced about a landmark paper claiming that human embryos were cleared of a deadly mutation using genome editing. In an article1 posted to the bioRxiv preprint server on 28 August, a team of prominent stem-cell scientists and geneticists question whether the mutation was actually fixed.

The 2 August Nature paper2, led by reproductive biologist Shoukhrat Mitalipov at the Oregon Health and Science University in Portland, described experiments in dozens of embryos to correct a mutation that causes a heart condition called hypertrophic cardiomyopathy.

In contrast to previous human-embryo editing studies, Mitalipovs team reported a high success rate at correcting a disease-causing mutation in a gene. The team claimed that the CRISPRCas9 genome editing tool was able to replace a mutant version of the MYBPC3 gene carried by sperm with a normal copy from the egg cell, yielding an embryo with two normal copies. Mitalipovs team also introduced a healthy version of the gene along with the CRISPR machinery, but they found that the corrected embryos had shunned it for the maternal version.

But there is reason to doubt whether this really occurred, reports a team led by Dieter Egli, a stem-cell scientist at Columbia University in New York City, and Maria Jasin, a developmental biologist at Memorial Sloan Kettering Cancer Center in New York City. George Church, a geneticist at Harvard Medical School in Boston, Massachusetts, is another co-author.

In their bioRxiv paper, Egli and Jasin and their co-authors say that there is no plausible biological mechanism to explain how a genetic mutation in sperm could be corrected based on the eggs version of the gene. More likely, they say, Mitalipovs team failed to actually fix the mutation and were misled into thinking they had by using an inadequate genetics assay. Egli and Jasin declined to comment because they say they have submitted their article to Nature.

The critique levelled by Egli et al. offers no new results but instead relies on alternative explanations of our results based on pure speculation, Mitalipov said in a statement.

But other scientists contacted by Nature's news team shared the Egli team's concerns. (Natures news team is editorially independent of its journal team.) Reproductive biologist Anthony Perry at the University of Bath, UK, says that after fertilization, the genomes of the egg and sperm reside at opposite ends of the egg cell, and each is enshrouded in a membrane for several hours. This fact, Perry says, would make it difficult for CRISPR-Cas9 to fix the sperms mutation based on the eggs version of the gene, using a process called homologous recombination. Its very difficult to conceive how recombination can occur between parental genomes across these huge cellular distances, he says.

Egli and Jasin raise that issue in their paper. They suggest that Mitalipovs team was misled into believing that they had corrected the mutation by relying on a genetic assay that was unable to detect a far likelier outcome of the genome-editing experiment: that CRISPR had instead introduced a large deletion in the paternal gene that was not picked up by their genetic assay. The Cas9 enzyme breaks DNA strands, and cells can attempt to repair the damage by haphazardly stitching the genome together, often resulting in missing or extra DNA letters.

That explanation makes sense, says Gatan Burgio, a geneticist at the Australian National University in Canberra. In my view Egli et al. convincingly provided a series of compelling arguments explaining that the correction of the deleterious mutation by self repair is unlikely to have occurred.

Another possibility Eglis team raise is that the embryos were produced without a genetic contribution from sperm, a process known as parthenogenesis. Mitalipovs team showed that the paternal genome was present in only 2 out of the 6 embryonic stem cell lines they made from gene-edited embryos.

Robin Lovell-Badge, a developmental biologist at the Francis Crick Institute in London, says that it is possible that there is a novel or unsuspected biological mechanism at work in the very early human embryo that could explain how Mitalipovs team corrected the embryos genomes in the manner claimed. He would first like to hear from Mitalipov before passing judgement. It simply says that we need to know more, not that the work is unimportant, Lovell-Badge says of Egli and Jasins paper.

In the statement, Mitalipovs said his team stands by their results. We will respond to their critiques point by point in the form of a formal peer-reviewed response in a matter of weeks.

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Doubts raised about CRISPR gene-editing study in human embryos - Nature.com

Study shows human stem cells restore mobility in Parkinson’s monkeys – Borneo Bulletin Online

| Marlowe Hood |

PARIS (AFP) Lab monkeys with Parkinsons symptoms regained significant mobility after neurons made from human stem cells were inserted into their brains, researchers reported Wednesday in a study hailed as groundbreaking.

The promising results were presented as the last step before human clinical trials, perhaps as early as next year, the studys senior author, Jun Takahashi, a professor at Kyoto University, told AFP.

Parkinsons is a degenerative disease that erodes motor functions. Typical symptoms include shaking, rigidity and difficulty walking. In advanced stages, depression, anxiety and dementia are also common.

Worldwide, about 10 million people are afflicted with the disease, according to the Parkinsons Disease Foundation.

Earlier experiments had shown improvements in patients treated with stem cells taken from human foetal tissue and likewise coaxed into the dopamine-producing brain cells that are attacked by Parkinsons.

Dopamine is a naturally occurring chemical that plays several key roles in the brain and body.

But the use of foetal tissue is fraught with practical and ethical problems.

So Takahashi and his colleagues, in a medical first, substituted so-called induced pluripotent stem cells (iPSCs), which can be easily made from human skin or blood. Within a year, some monkeys who had could barely stand up gradually recovered mobility.

They became more active, moving more rapidly and more smoothly, Takahashi said by email. Animals that had taken to just sitting start walking around in the cage.

These findings are strong evidence that human iPSC-derived dopaminergic neurons can be clinically applicable to treat Parkinsons patients, he said.

Experts not involved in the research described the results as encouraging.

The treatment, if proven viable, has the potential to reverse Parkinsons by replacing the dopamine cells that have been lost a groundbreaking feat, said David Dexter, deputy research director at Parkinsons UK.

Not only did the new cells survive but they also integrated with the existing neuronal network, he said.

Neurons made from foetal tissue grafted into brains have been known to survive for more than a decade, and the researchers said they expected those derived from iPSCs to last just as long.

Tilo Kunath, Parkinsons Senior Research Fellow at the University of Edinburgh, said the outcome was extremely promising, and highlighted the advantage of avoiding stem cells extracted from human foetal tissue.

It means that this therapy can be used in any country worldwide, including Ireland and most of South America, where medical use of human embryonic stem cells is banned.

The results, reported in the journal Nature, were not the same for the dozen monkeys in the experiment, each of which received donor neurons from a different person.

Some were made with cells from healthy donors, while others were made from Parkinsons disease patients, said lead author Tetsuhiro Kikuchi, also from Kyoto University.

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Study shows human stem cells restore mobility in Parkinson's monkeys - Borneo Bulletin Online

FDA Cracks Down On Stem-Cell Clinics Selling Unapproved Treatments – NPR

Adult stem cells can be extracted from human fat. Patrick T. Fallon /The Washington Post/Getty Images hide caption

Adult stem cells can be extracted from human fat.

The Food and Drug Administration is cracking down on "unscrupulous" clinics selling unproven and potentially dangerous treatments involving stem cells.

Hundreds of clinics around the country have started selling stem cell therapies that supposedly use stem cells but have not been approved as safe and effective by the FDA, according to the agency.

"There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt assurances to patients based on unproven and, in some cases, dangerously dubious products," FDA Commissioner Scott Gottlieb said in a statement Monday.

The FDA has taken action against clinics in California and Florida.

The agency sent a warning letter to the US Stem Cell Clinic of Sunrise, Fla., and its chief scientific officer, Kristin Comella, for "marketing stem cell products without FDA approval and significant deviations from current good manufacturing practice requirements."

The clinic is one of many around the country that claim to use stem cells derived from a person's own fat to treat a variety of conditions, including Parkinson's disease, amyotrophic lateral sclerosis (ALS), and lung and heart diseases, the FDA says.

The Florida clinic had been previously linked to several cases of blindness caused by attempts to use fat stem cells to treat macular degeneration.

The FDA also said it has taken "decisive action" to "prevent the use of a potentially dangerous and unproven treatment" offered by StemImmune Inc. of San Diego, Calif., and administered to patients at California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, Calif.

As part of that action, the U.S. Marshals Service seized five vials of live vaccinia virus vaccine that is supposed to be reserved for people at high risk for smallpox but was being used as part of a stem-cell treatment for cancer, according to the FDA. "The unproven and potentially dangerous treatment was being injected intravenously and directly into patients' tumors," according to an FDA statement.

Smallpox essentially has been eradicated from the planet, but samples are kept in reserve in the U.S. and Russia, and vaccines are kept on hand as a result.

But Elliot Lander, medical director of the California Stem Cell Treatment Centers, denounced the FDA's actions in an interview with Shots.

"I think it's egregious," Lander says. "I think they made a mistake. I'm really baffled by this."

While his clinics do charge some patients for treatments that use stem cells derived from fat, Lander says, none of the cancer patients were charged and the treatments were administered as part of a carefully designed research study.

"Nobody was charged a single penny," Lander says. "We're just trying to move the field forward."

In a written statement, U.S. Stem Cell also defended its activities.

"The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the Food and Drug Administration," according to the statement.

"We have helped thousands of patients harness their own healing potential," the statement says. "It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards."

But stem-cell researchers praised the FDA's actions.

"This is spectacular," says George Daley, dean of the Harvard Medical School and a leading stem-cell researcher. "This is the right thing to do."

Daley praised the FDA's promise to provide clear guidance soon for vetting legitimate stem-cell therapies while cracking down on "snake-oil salesmen" marketing unproven treatments.

Stem-cell research is "a major revolution in medicine. It's bound to ultimately deliver cures," Daley says. "But it's so early in the field," he adds. "Unfortunately, there are unscrupulous practitioners and clinics that are marketing therapies to patients, often at great expense, that haven't been proven to work and may be unsafe."

Others agreed.

"I see this is a major, positive step by the FDA," says Paul Knoepfler, a professor of cell biology at the University of of California, Davis, who has documented the proliferation of stem-cell clinics.

"I'm hoping that this signals a historic shift by the FDA to tackle the big problem of stem-cell clinics selling unapproved and sometimes dangerous stem cell "treatments" that may not be real treatments," Knoepfler says.

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FDA Cracks Down On Stem-Cell Clinics Selling Unapproved Treatments - NPR

Novartis AG’s CAR-T cell therapy for leukemia approved by FDA in ‘historic action’; price to be based on outcomes – MarketWatch

Novartis AG's NVS, -0.57% CAR-T cell therapy was approved by the Food and Drug Administration on Wednesday, making it the first gene therapy to be available in the U.S. Novartis' Kymriah was approved for young people up to age 25 with a form of acute lymphoblastic leukemia. CAR-T, or chimeric antigen receptor T-cell therapy, uses a patient's immune T-cells and re-engineers them to better fight cancer. As such, each dose of Kymriah is customized to the individual patient's T-cells through genetic modification. Novartis said on Wednesday that it will work with the Centers for Medicare and Medicaid Services so medicine prices can be "based on the clinical outcomes achieved, which would eliminate inefficiencies from the health care system." For Kymriah, Novartis is also working with CMS "to allow for payment only when pediatric and young adult ALL patients respond to Kymriah by the end of the first month." Novartis did not give any specifics as to what the price range might be. Even before Novartis' Kymriah was approved, there was concern about pricing of the new therapy, given that new therapies are typically priced based on level of innovation and cancer is a particularly expensive area. On Wednesday, the FDA also expanded approval of Roche's ROG, +0.29% Genentech's rheumatoid arthritis drug Actemra to treat CAR-T cell-induced cytokine release syndrome, which consists of high fever and flu-like symptoms and can be life-threatening; nearly 70% of patients had CRS completely resolved in two weeks using one or two doses of Actemra, the FDA said. Kite Pharma, which is also working in the CAR-T space, has also been racing to gain FDA approval; the biotech's $11 billion acquisition by Gilead Sciences Inc. GILD, +0.05% was reported earlier this week. Gilead shares surged 5.5% in extremely heavy midday trade. Novartis shares declined 1% in heavy midday trade. Novartis shares have risen 2.8% over the last three months, compared with a 1.6% rise in the S&P 500 SPX, +0.20%

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Novartis AG's CAR-T cell therapy for leukemia approved by FDA in 'historic action'; price to be based on outcomes - MarketWatch

Modern Health & Wellness of Lima institutes regenerative stem cell … – Lima Ohio

LIMA A chiropractic center that specializes in treating chronic pain is now offering regenerative stem cell therapy, a new healing procedure that is the first of its kind in the area.

Modern Health & Wellness, located at 2425 Allentown Road, has partnered with Ohio Stem Cell and the Stem Cell Institute of America to bring this procedure to the region. According to Ohio Stem Cells doctors, patients can experience a significant decrease in pain and an improvement in range of motion within weeks of one treatment.

The research behind this technology is showing amazing results, said Modern Health & Wellness owner Dr. Patrick Gorman. In time, its our hope that this truly amazing therapy will eliminate the need for drugs and surgery.

Ohio Stem Cell doctors will be on site to administer the regenerative stem cell therapy, which has been approved by the Food and Drug Administration. Gorman said painless stem cell injections will help with arthritic and/or degenerative conditions, especially those found in the knees, hips, shoulders, neck and lower back.

These treatments can repair tissue in the body that has been damaged from age, disease or degeneration. It is accomplished by pinpointing the impaired areas, removing the swelling with anti-inflammatory properties and healing them by regenerating new cells and tissue.

This type of therapy is particularly effective in treating conditions such as degenerative arthritis, degenerative cartilage and ligaments, bone spurs, degenerative joint disease, bursitis and tendinitis.

Stem cell injections and therapy can help people that have bone-on-bone arthritis in their knee, and it can actually regenerate the tissue like the cartilage and the meniscus to help heal that area and allow people to go back to activities and function like they did before, Gorman said.

For those who may be concerned that stem cell therapy is against their religious beliefs, Gorman said it is illegal in the United States to obtain stem cells via an abortion.

The clinics that are harvesting these stem cells actually have to demonstrate and prove beyond a shadow of a doubt that these have been harvested via a successful C-section, he said. No babies are being aborted to obtain these cells.

Gorman added that anyone who is thinking of undergoing regenerative stem cell therapy should set up a consultation at the wellness center, or attend monthly lectures on this topic. The lectures are provided two to three times a month at the Area Agency on Aging 3, which is located in the same building as the wellness center.

We have a lot of people attend those lectures, and its mainly there to help educate people and explain to them what stem cell has done in the past, and what it can do for you, he said.

The next lecture is scheduled for 10 a.m. Sept. 9 at AAA3. Another lecture will be held at 10 a.m. Sept. 23.

Dr. Patrick Gorman, owner of Modern Health & Wellness in Lima, speaks to attendees at a ribbon-cutting ceremony celebrating the centers newly implemented regenerative stem cell therapy on Thursday.

http://limaohio.com/wp-content/uploads/2017/08/web1_stem-cell.jpgDr. Patrick Gorman, owner of Modern Health & Wellness in Lima, speaks to attendees at a ribbon-cutting ceremony celebrating the centers newly implemented regenerative stem cell therapy on Thursday. John Bush | The Lima News

Reach John Bush at 567-242-0456 or on Twitter @Bush_Lima.

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Modern Health & Wellness of Lima institutes regenerative stem cell ... - Lima Ohio