FDA steps up scrutiny of stem cell therapies – Reuters

(Reuters) - The U.S. Food and Drug Administration (FDA) is stepping up efforts to better regulate an emerging field of medicine that holds significant promise for curing some of the most troubling diseases by using the body's own cells.

A small number of "unscrupulous actors" have seized on the promise of regenerative medicine and stem cell therapies to mislead patients based on unproven, and in some cases, dangerously dubious products, the FDA said on Monday. (bit.ly/2iB4Xls)

Regenerative medicine makes use of human cells or tissues that are engineered or taken from donors. Health regulators have approved some types of stem cell transplants that mainly use blood and skin stem cells after clinical trials found they could treat certain types of cancer and grow skin grafts for burn victims.

But many potential therapies are still in the earliest stages of development. These therapies are sometimes advertised with the promise of a cure, but they often have scant evidence backing their efficacy or safety.

The FDA said it had taken steps to tackle the problem of some "troubling products" being marketed in Florida and California.

Federal officials on Friday seized from San Diego-based StemImmune Inc vials containing hundreds of doses of a vaccine reserved only for people at high risk for smallpox, the FDA said. (bit.ly/2wC1DMU)

The seizure followed recent FDA inspections that confirmed the vaccine was used to create an unapproved stem cell product, which was then given to cancer patients, the agency added.

The FDA also sent a warning letter to a Sunrise, Florida-based clinic for marketing stem cell products without regulatory approval and for major deviations from current good manufacturing practices. (bit.ly/2giGlx9)

The health regulator will present a new policy framework this fall that will more clearly detail the "rules of the road" for regenerative medicine, FDA Commissioner Scott Gottlieb, a cancer survivor, said in a statement.

Reporting by Natalie Grover in Bengaluru; Additional reporting by Tamara Mathias; Editing by Sai Sachin Ravikumar

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FDA steps up scrutiny of stem cell therapies - Reuters

Canto-Soler joins team at Gates Center for Regenerative Medicine to develop cell-based treatments – CU Anschutz Today (press release)

Valeria Canto-Soler at work in the lab at the Gates Center for Regenerative Medicine.

When Valeria Canto-Soler, Ph.D., was a biology student in Argentina, she dreamed of a career studying elephants and other African wildlife in their natural habitat.

But life took her on a different journey. In July, Canto-Soler joined the Department of Ophthalmology and the Gates Center for Regenerative Medicine as the Doni Solich Family Endowed Chair in Ocular Stem Cell Research.

I like to joke about it, she says. Instead of spending my life studying animals in the wilds of Africa, Im in a dark room sitting in front of a microscope.

After an international search, Canto-Soler also was named director of CellSight, the Ocular Stem Cell and Regeneration Research Program, in partnership with the Gates Center and the Department of Ophthalmology. She also will be an Associate Professor of Ophthalmology at the CU Anschutz School of Medicine.

This $10 million ocular stem cell and regeneration program initiative began with a $5 million grant from the Gates Frontier Fund to research the potential for stem cells to treat age-related macular degeneration, the leading cause of blindness in people ages 50 and older.

I dreamed of launching a stem cell research program like this for years, she says. The leadership at both the Gates Center and the Department of Ophthalmology has the same vision that I have. Working together, we can make it happen.

Canto-Soler grew up in Mendoza, Argentina, a city on the eastern side of the Andes Mountains. Similar to Denver in that its nestled in the foothills, Mendozas close proximity to the mountains gave her the opportunity to hike, explore and marvel at the natural wildlife she encountered.

But when it came to a career choice, it was more difficult for her to decide how to direct her love of nature and biology. In contrast to the U.S., students in Argentina have to decide on a career early.

Its a very important decision and there are very few chances for you to change your mind after that, she says.

As a young biology student, Canto-Soler found herself drawn to the study of the human nervous system and how the sense organs work.

Year by year, I felt more and more fascinated by the biology of the human body, she says. In the last two years of biology school, I started to work in a lab studying the nervous system. That defined my future.

Canto-Soler earned a B.S. in Biology from the University of Cordoba School of Natural Sciences, Cordoba, Argentina in 1996. In 2002, she completed a Ph.D. in Biomedical Sciences at the Austral University School of Medicine in Buenos Aires.

After she earned her Ph.D., Canto-Soler had the opportunity to explore new vistas. She was accepted as a Fellow with the Retinal Degenerations Research Center in the Department of Ophthalmology at Johns Hopkins University School of Medicine in Baltimore. She worked with renowned scientist Ruben Adler, MD, at the Wilmer Eye Institute.

I was so excited the focus of his research was the development of the eye, Canto-Soler says. It was perfect for me.

She thought her fellowship would provide her the knowledge and experience she could take back to Argentina, but she found new challenges to keep her in the U.S. When her mentor, Dr. Adler, died in 2007, she took over his role at Wilmer to continue their work.

In 2014, Canto-Soler and her team created a miniature human retina in a petri dish, using human stem cells. The mini retinas had functioning photoreceptor cells capable of sensing light. This cutting-edge research opened up the potential to take cells from a patient who suffers from a particular retinal disease, such as macular degeneration, and use them to generate mini retinas that would recapitulate the disease of the patient; this allows studying the disease on a human context directly, rather than depending on animal models.

This research could lead to personalized medicine and drug treatments for specific patient needs. At CellSight, Canto-Soler will work with clinicians and members of the Gates Center to create patient registries and cell banking. She hopes her research will someday result in cell-based treatments; retinal patches, for example, which could be transplanted into a patients eye, possibly curing blindness.

Once you transplant a retinal patch, the cells have to establish all the right connections with the patients own retinal cells in order to process the information and produce a visual image, she says. No one really knows how to do that yet.

But shes confident the clinicians from the Department of Ophthalmology, and the researchers at CellSight and the Gates Center, will work together to make the dream a reality.

Im definitely a dreamer, Canto-Soler says. I never imagined we could generate human mini retinas in a petri dish. And to see that happen made me a believer. I believe our scientific dreams can come true if we pursue them in the right way.

The letters and emails she receives from those who have family members or friends suffering from sight problems or blindness inspire her. Theyre also looking for answers.

Its what gets me motivated to come to work every day, she says. Im excited to think about how we could help people and the impact that would make in their lives.

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Fetal membranes may help transform regenerative medicine – Medical Xpress

August 30, 2017

A new review looks at the potential of fetal membranes, which make up the amniotic sac surrounding the fetus during pregnancy, for regenerative medicine.

Fetal membranes have been used as biological bandages for skin grafts as well as for serious burns. They may also have numerous other applications because they contain a variety of stem cells, which might be used to treat cardiovascular and neurological diseases, diabetes, and other medical conditions.

"The fetal membranes have been used successfully in medical applications for over a century, but we continue to discover new properties of these membranes," said Dr. Rebecca Lim, author of the STEM CELLS Translational Medicine review. "The stem cell populations arising from the fetal membranes are plentiful and diverse, while the membrane itself serves as a unique biocompatible scaffold for bioengineering applications."

Explore further: Stem cell research could prevent premature births

More information: Rebecca Lim. Concise Review: Fetal Membranes in Regenerative Medicine: New Tricks from an Old Dog?, STEM CELLS Translational Medicine (2017). DOI: 10.1002/sctm.16-0447

Researchers from the University of Reading have developed the first fully tissue-engineered fetal membrane from human stem cells that could significantly reduce the number of premature births.

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FDA warns US Stem Cell Clinic in Sunrise, Florida, of significant deviations – Florida Trend

The U.S. Food and Drug Administration today posted awarning letterissued to US Stem Cell Clinic of Sunrise, Florida, and its Chief Scientific Officer Kristin Comella for marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk.

Stem cell clinics that mislead vulnerable patients into believing they are being given safe, effective treatments that are in full compliance with the law are dangerously exploiting consumers and putting their health at risk, said FDA Commissioner Scott Gottlieb, M.D. As the FDA takes new steps to advance an efficient, modern approach to the regulation of cell based regenerative medicine, at the same time we will be stepping up our enforcement actions against clinics that abuse the trust of patients and, more important, endanger their health with unsanitary conditions or by purporting to have treatments which may not provide any benefit.

The FDA recently inspected US Stem Cell Clinic and found that the clinic was processing adipose tissue (body fat) into stromal vascular fraction (stem cells derived from body fat) and administering the product both intravenously or directly into the spinal cord of patients to treat a variety of serious diseases or conditions, including Parkinsons disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis. The FDA has not reviewed or approved any biological products manufactured by US Stem Cell Clinic for any use.

Our aim is to provide an efficient route to market for promising technologies, Gottlieb continued. But at the same time, we will take a firm stance against those that prey on the medical promise of regenerative cell therapies to market treatments potentially unsafe or unproven so-called cures. We want a regulatory framework that helps efficiently and effectively advance the many promising technologies in the field of regenerative cell therapies. The FDA cant allow a small number of bad actors to leverage that promise to mislead patients and put them at risk.

During the inspection, FDA investigators also documented evidence of significant deviations from current good manufacturing practices in the manufacture of at least 256 lots of stem cell products by the clinic. For example, the firm was cited for its failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections.

US Stem Cell Clinic also tried to impede the FDAs investigation during the most recent inspection by refusing to allow entry except by appointment and by denying FDA investigators access to employees. Refusing to permit entry or FDA inspection is a violation of federal law.

The FDA has requested a response from US Stem Cell Clinic, including a statement of how the deviations noted in the warning letter will be corrected, within 15 working days. Companies that do not correct deviations risk additional enforcement action such as seizure, injunction, or prosecutions.

Health care professionals and consumers should report any adverse events related to treatments provided by US Stem Cell Clinic to the FDAsMedWatchAdverse Event Reporting program. To file a report, use theMedWatch Online Voluntary Reporting Form. The completedformcan be submitted online or via fax to 1-800-FDA-0178.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Human Stem Cells Repair Spinal Cord Injuries In Mice At Human Biological Rate – IFLScience

Researchers at the University of California San Diego and at the San Diego Veterans Administration Medical Center have shown that human neural stem cells (NSCs) grafted onto the spinal cord injuries of mice produced a functional recovery after one year. The team has shown that the NSCs continue to grow slowly and steadily even18 months after implantation.

The study is published in the Journal of Clinical Investigation and set out to answer how long it would take for the cells to mature inside the rodents. Mice and humans have a very different pace when it comes to cell biology.

"The NSCs retained an intrinsic human rate of maturation despite being placed in a traumatic rodent environment," lead author Professor Paul Lu said in a statement. "That's a finding of great importance in planning for human clinical trials."

The researchers were worried that the animal model would not reflect the how this approach might in the future work in humans. For example, pregnancies last 21 days in mice and 280 days in humans. And the weight of a toddlers brain is comparable with that of a 20-day-old mouse.

"Most NSC grafting studies have been short-term, measuring survival times in weeks to a few months," added co-author Professor Mark Tuszynski. "That's not enough time to fully measure the growth and maturation rate of human NSCs or what changes might occur farther out from the original grafting. These are important considerations, not just for the basic science of stem cell biology, but for the practical design of translational human trials using NSCs for spinal cord injuries."

The researchers report that the cells maintained their natural maturation pace even though they were in a foreign environment. Thats why it took several months for the lesions to begin healing. The scientists noted that improvement in the mice mobility only happened after more mature nerve cells formed. As the grafts aged, they displayed the expected pruning and cell redistribution activities that help the development of fewer but more mature cells.

"The bottom line is that clinical outcome measures for future trials need to be focused on long time points after grafting," said Tuszynski. "We need to take into account the prolonged developmental biology of neural stem cells. Success, it would seem, will take time."

The team noticed that none of the implanted NSCs migrated from the graft but some supportive astrocytes cells did, which could be a potential safety concern. No tumors or anomalous formation were created by these cells and modified grafting should fix the problem. A better understanding of this approach, so that the results can be carefully assessed, is required before we can even think to try it on humans.

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First Atlas of B-cell Clones in the Human Body Charted – Technology Networks

Credit: Alexander H. Farley

A new anatomic atlas of how B cells the immune systems producer of antibodies link up to form networks has been charted by researchers from the Perelman School of Medicine at the University of Pennsylvania. This map will be an important resource for researchers and clinicians studying infectious diseases, the microbiome, vaccine responses, and tissue-specific immunity.

Our bodies are filled with B-cell clones, said senior author Nina Luning Prak, MD, PhD, an associate professor of Pathology and Laboratory Medicine. B cells are diverse in the number of distinct antibodies their genes can encode. Immunologists estimate there are about 100 billion different types of antibodies per person.

We dubbed our study Blood & Guts, when we started to see that B-cell clone populations partition into two broad networks, Prak said. There are large networks in the gut (the jejunum, ileum, and colon) and different networks in blood-rich regions such as blood, bone marrow, spleen, and lung. We essentially discovered and mapped the B-cell clonal geography of the human body. They did this with the help of consented human organ donors who allowed their tissues to be used for research purposes, in addition to transplantation.

When B cells are in response-to-invader mode, they undergo what is termed a clonal expansion, which can occur in a variety of tissues. These populations are simply collections of cells that can all be traced back to the same parent B cell.

B cells combat infection locally, activating specific T cells and molecules that influence nearby immune cells within specific tissues. On the whole, the distribution and movement of B-cell clones influences how infections are controlled throughout the body. Past animal studies have found that these specifics, which differ tissue by tissue, are important for building up protective immunity and keeping the helpful bacteria species in the microbiome happy. However, researchers did not know the lay of the B-cell landscape, so to speak, until now.

The team also found more memory B cells, with their associated uber-diverse antibodies, in the gut network group. These gastrointestinal populations were more related genetically compared to the blood-rich tissue groups.

Presumably, this is because the gut is one of the organs that is constantly bombarded by stimuli from the environment whether the stimuli that drive these B-cell clones are derived from the microbiome or other pathogens is not yet known, Prak said. The greater interconnection among B cells that share similar antibodies in the gut could be the bodys way of coordinating immune responses across large distances along the gastrointestinal tract, she suggests.

To make the map, the investigators sequenced a region of the B-cell gene that encodes an antibody component called the heavy-chain variable domain. This part of the antibody is generated by multiple rearrangements in the gene and contributes to the vast diversity of antibodies that humans generate over a lifetime. These antibody gene shuffles were analyzed using DNA from the seven tissue types and blood from the organ donors.

The computational analysis of the B-cell lineages, with over 38 million gene rearrangements, required the development of new data analysis and visualization tools. Prak says it took the group, which included members of her lab and a team of computational biologists led by Uri Hershberg at Drexel University, two-and-a-half years to complete the meticulous sequencing and data analysis to plot the map.

Co-author Donna Farber, from Columbia University, directed the organ donor tissue program for acquiring the tissue samples. The donors, the research surgeons who performed the tissue acquisition, and the organ procurement organization, LiveOnNY, were all critical for being able to carry out this work, Prak said.

She likens tracing each line of B cells through the body to the Verizon guy in the commercial moving from spot to spot asking, Can you hear me now? In this analogy, the Verizon guy stands in a particular tissue asking whether a cell from a given collection of related B cells is present. Each B-cell clonal lineage is like a cell phone network. The geographic regions covered by the each network are the tissues and the entire planet Earth is the body of a single person.

Prak's team traced over 933,000 B-cell lineages and replicated their results using the tissues from the six organ donors. In the case of our research, we have the equivalent of data from six different Earths, she said.

That's a lot of testing millions of Verizon commercials' worth. Our fantasy for the future is to create organ-specific immune monitoring assays. If we can define features of the antibody repertoire that are unique to particular tissues, we may be able to monitor tissue-specific immune responses using blood-based clinical lab tests.

Such tests might be used to monitor immune responses to vaccines or inappropriate antibody responses in organ-specific autoimmune diseases; however, the first step towards that is knowing the location of B-cell clones.

The B-cell clonal network data can be accessed and analyzed further using the teams computational framework for analysis, ImmuneDB. Continuously updated applications for data analysis and visualization of B-cell data are also available here and here.

This article has been republished frommaterialsprovided bythe University of Pennsylvania. Note: material may have been edited for length and content. For further information, please contact the cited source.

Reference:

Meng, W., Zhang, B., Schwartz, G. W., Rosenfeld, A. M., Ren, D., Thome, J. J., . . . Prak, E. T. (2017). An atlas of B-cell clonal distribution in the human body. Nature Biotechnology. doi:10.1038/nbt.3942

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FDA Cracks Down on Stem Cell Clinics But Patients Are Still at Risk – TIME

On Monday, the U.S. Food and Drug Administration (FDA) announced that the agency is targeting clinics that offer unproven stem cell therapies , calling such offices "unscrupulous clinics" selling "so-called cures." The FDA seized materials from one clinic in California, and sent a warning letter to another in Florida.

The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work," said FDA Commissioner Dr. Scott Gottlieb in a statement.

The agency announced that on Friday, Aug. 25th, U.S. Marshals seized five vials of a vaccine that is intended for people at a high risk for smallpox (for example, people in the military) from StemImmune Inc. in San Diego, California. The FDA says it learned that StemImmune was using the vaccines as well as stem cells from body fat to create an unapproved stem cell therapy. On its website, StemImmune says "The patients own (autologous, adult) stem cells, armed with potent anti-cancer payloads, function like a Trojan Horse, homing to tumors and cancer cells, undetected by the immune system." The stem cell treatment was injected into the tumors of cancer patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California.

MORE: Three People Are Nearly Blind After Getting a Stem Cell Treatment

The FDA also sent a warning later to U.S. Stem Cell Clinic in Sunrise, Florida. The company recently came under public scrutiny when a March report revealed that three people had severe damage to their vision one woman went blindafter they were given shots of what the company said were stem cells into their eyes during a study sponsored by the clinic. The FDA says that an inspection of U.S. Stem Cell Clinic revealed that the clinic was using stem cells to treat diseases like Parkinson's, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis. According to the FDA, there are currently only a limited number of stem cell therapies approved by the agencyincluding ones involving bone marrow, for bone marrow transplants in cancer care, and cord blood for specific blood-related disorders. There are no approved stem cell treatments for other diseases.

The FDA says U.S. Stem Cell Clinic also attempted to interfere with the FDA's most recent inspection by refusing to allow FDA investigators to enter without an appointment, and denied the agency access to its employees. "Refusing to permit entry or FDA inspection is a violation of federal law," the FDA says.

Action by the FDA on clinics promoting unproven stem cell therapies is "a long time coming," says Sean Morrison, former president of the International Society for Stem Cell Research (ISSCR) and d irector of the Childrens Research Institute at UT Southwestern. "C linics are preying on the hopes of desperate patients claiming they can cure all manner of diseases with stem cells that have not been tested in clinical trials, and in some cases, are flat out impossible."

In the past, medical experts were concerned over Americans traveling to countries with less medical regulation for stem cell therapies, but Morrison says such clinics have been popping up stateside over the last five years. "It's not a few companies in the U.S. making claims about therapies with stem cells," says Morrison. "It's scores of companies. The problem has exploded in the U.S."

Morrison blames the lack of FDA crackdown in the past for the growing problem. "At some point people made the calculation that the FDA didnt seem to be enforcing these laws," he says. "The margins are huge. They charge people tens of thousands of dollars."

Since stem cell therapy is still an active and legitimate area of scientific research, it can be hard for Americans to figure out what is safe and effective and what is not. Even when it comes to clinical trials, the scientific soundness is murky. A July 2017 paper reported that 18 U.S. companies have registered "patient-sponsored" stem cell studies on ClinicalTrials.gov. That means that the patients receiving the treatment paid for them, which isn't the case in more legitimate studies. None of these were gold standard studies: meaning the people were not randomly assigned to receive the treatment or not, so the participants knew they were receiving the therapy that could bias the results. Only seven of the studies disclosed upfront that patients had to pay to join the study, and none revealed that the costs ranged from $5,000 to $15,000 a treatment, Wired reports .

While Morrison says he's glad the FDA has taken action, he says it's not enoughat least not yet. "The FDA has to show that there is really a sustained commitment to enforcement," he says. "When the FDA wasnt bringing actions against these companies, I think people thought this meant that it was a gray area and that they could get away with it."

Undoing that damage could be a long process, and one that Morrison says needs consistent attention by the agency. In a letter released on Monday , FDA commissioner Gottlieb said the agency is stepping up enforcement of stem cell therapies and regenerative medicine. "Ive directed the FDA to launch a new working group to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health," said Gottlieb. Whether those efforts have an impact remains to be seen.

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CSL Behring buys Calimmune for early stem cell, gene therapy boost – FierceBiotech

CSL Behring has paid out $91 million upfront for biotech Calimmune and gains a preclinical asset for sickle cell disease and -thalassemia, adding to its blood disease pipeline.

The biotech is working onexvivo hematopoietic stem cell (HSC) gene therapy, with R&D facilities in Pasadena, California, and Sydney, New South Wales, Australia, that will now transfer over to CSL.

For its $91 million, and $300-plus in biobucks, CSL also gets two platform technologies, Select+ and Cytegrity, which are designed to address some of the major challenges currently associated with the commercialization of stem cell therapy, according to the company.

This includes the ability to manufacture consistent, high-quality productsand to improve engraftment, efficacy and tolerability, it said in a statement. Both technologies have broad applications in ex vivo stem cell gene therapy.

Calimmune shares in our promise and focus to improve the lives of patients with rare and serious medical conditions, said CSL CEO and managing director Paul Perreault. The acquisition represents another important step in the execution of our strategy for sustainable growth. Calimmunes scientific accomplishments are impressive.

The team has built a robust technology platform, and designed a promising HSC gene therapy candidate, CAL-H, which strongly aligns with our longer-term strategic goals, and complements our core competencies and areas of therapeutic focus, Perreault added. While Calimmune is still in the early stages, we believe that our combined strengths have tremendous potential to change treatment paradigms, and most importantly, significantly improve the lives of our patients.

RELATED: CSL heart attack drug hits on safety, misses efficacy in PhIIb

Calimmunes chief, Louis Breton, added: We are excited to become part of CSL Behring. They are an established global industry leader in protein-replacement therapies and have a proven track record of driving innovations through the development pipeline and delivering differentiated products to the global marketplace. Together, we are well-positioned to take our achievements to the next level.

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CSL Behring buys Calimmune for early stem cell, gene therapy boost - FierceBiotech

MS sufferer gets pioneering stem cell treatment – Gloucestershire Live

Multiple sclerosis sufferer Roy Palmer is about to embark on the next phase of his pioneering treatment.

But it comes with risks he is prepared to take in the hope it will cure the debilitating condition.

The 43-year-old father of two from Quedgeley is determined it will work. He was diagnosed with relapsing remitting MS but now has the secondary progressive form of the disease, which means it gets steadily worse.

He said: I fought for a year to get hematopoietic stem cell transplantation and many people told me I didnt fit the criteria but I didnt let that stop me.

Mr Palmer had a week of injections to draw the stem cells from his bone marrow.

He and his wife Helen travelled to Hammersmith Hospital in London where he was given a day of chemotherapy.

Mr Palmer lost his hair as a result and was left feeling sick and tired.

The stem cells have been frozen and will be reintroduced to his body after another aggressive course of chemotherapy.

It will be fed directly into a main artery in his chest before Mr Palmer spends the next four weeks in isolation.

He will start the treatment on September 18 his 24th wedding anniversary.

Mr Palmer said: Im not someone to sit around and feel sorry for myself.

If the treatment works then, oh my God, I couldnt begin to describe what it would mean to me.

He added: To be able to walk out of my front door would mean the world.

I know Im lucky to be able to get the treatment. Im worried, my immune system will be obliterated, but I have to give this everything. Im a fighter and determined to make this work.

Mr Palmers family back his decision to undergo HSCT treatment, although they worry about the effect it will have.

His 45-year-old wife said: When they give the chemotherapy it brings the body back down to zero.

It will stop any immune system and take some time for the body to start getting back to normal.

When Roys levels are up they will start to reintroduce the stem cells.

The MS Society website says HSCT aims to reset the immune system to stop it attacking the central nervous system.

It uses chemotherapy to remove the harmful immune cells and then rebuilds the immune system using haematopoietic stem cells found in bone marrow.

They can produce all the different cells in the blood.

Mrs Palmer said: Im happy for Roy to take that risk and to support him but it is a lethal dose of chemo.

The treatment can be done abroad and costs around 60,000. In the past we were considering that option but there is no aftercare.

The couples daughter Abi, 12, said: I feel a little scared for dad but okay. I cant remember him walking.

And 20-year-old son Jack said: Dad has been in a chair for about 10 years and to see him walk again would mean everything.

Just standing next to each other would mean the world.

Once the stem cells are back in Mr Palmers body the hope is he will make a full recovery and be free of MS,

He said: It will be great to not have to ask people to do things for me.

I do what I can but I dont like to hang around waiting.

I want people to know there is treatment and it can be a fight but Ive got to do this now.

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MS sufferer gets pioneering stem cell treatment - Gloucestershire Live

Australian Market Declines – Markets Insider

(RTTNews) - The Australian stock market is declining on Monday after the banking regulator's announcement of the launch of an independent inquiry into Commonwealth Bank dragged down banking stocks. In addition, weakness in base metal prices weighed on mining stocks.

In late-morning trades, the benchmark S&P/ASX 200 Index is declining 39.80 points or 0.69 percent to 5,704.10, off a low of 5,700.50. The broader All Ordinaries Index is down 36.70 points or 0.63 percent to 5,766.70.

The big four banks - ANZ Banking, Westpac, Commonwealth Bank and National Australia Bank - are lower in a range of 1.1 percent to 1.7 percent.

The Australian Prudential Regulation Authority or APRA said it will launch an inquiry to look at governance, culture and accountability practices at Commonwealth Bank after recent allegations that it violated laws.

In the mining space, Rio Tinto is declining more than 1 percent and Fortescue Metals is losing almost 2 percent, while BHP Billiton is up 0.2 percent.

Gold miners are advancing after gold prices gained on Friday. Newcrest Mining is edging up less than 0.1 percent and Evolution Mining is adding almost 1 percent.

Oil stocks are also higher after crude oil prices rose on Friday. Santos is rising more than 2 percent, Oil Search is adding 0.3 percent and Woodside Petroleum is up 0.2 percent.

Australian Pharmaceutical Industries, the operator of Priceline pharmacies, has withdrawn from the potential acquisition of Laser Clinics Australia saying the sale price was too high. Shares of API are adding 0.2 percent.

Amaysim Australia reported a 6.5 percent decline in net profit for the full year, while its underlying earnings rose 22.9 percent. The mobile service provider's shares are gaining almost 6 percent.

CSL has agreed to acquire U.S. biotechnology company Calimmune, which is developing a stem cell gene therapy to treat rate conditions such as sickle cell disease, for an up-front payment of $91 million. Shares of CSL are adding 0.3 percent.

Ten Network has been acquired by U.S. media giant CBS Corp. Shares of Ten Network are in a trading halt since June 13 after it was placed into voluntary administration.

In the currency market, the Australian dollar rose against the U.S. dollar, which weakened after the Jackson Hole speeches by global central bankers. In early trades, the local unit was trading at US$0.7925, up from US$0.7904 on Friday.

On Wall Street, stocks closed mixed on Friday after seeing early strength that partly reflected optimism about tax reform following comments from President Donald Trump's chief economic adviser Gary Cohn.

The Nasdaq edged down 5.68 points or 0.1 percent to 6,265.64, while the Dow inched up 30.27 points or 0.1 percent to 21,813.67 and the S&P 500 ticked up 4.08 points or 0.2 percent to 2,443.05.

The major European markets moved modestly lower on Friday. While the French CAC 40 Index slipped by 0.2 percent, the U.K.'s FTSE 100 and the German DAX Index both edged down by 0.1 percent.

Crude oil prices gained on Friday as the dollar fell and the U.S. petroleum industry braced for Hurricane Harvey. WTI crude rose $0.44 or 0.9 percent to close at $47.87 a barrel on the New York Mercantile Exchange.

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