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Cells may hold key to treating Parkinson’s disease – Hindustan Times

By NEVAGiles23

According to recent study, advancements in materials from this study could potentially help patients requiring stem cell therapies for spinal cord injuries, stroke, Parkinsons disease, Alzheimers disease, arthritic joints or any other condition requiring tissue regeneration. Earlier research revolved around the role of autoimmunity in terms of a treatment.

Its important in the context of cell therapies for people to cure these diseases or regenerate tissues that are no longer functional, shared Samuel I. Stupp, director of Northwesterns Simpson Querrey Institute for BioNanotechnology and Board of Trustees Professor of Materials Science and Engineering, Chemistry, Medicine and Biomedical Engineering.

Cells in our bodies are constantly being signalled with many types of instructions coming from proteins and other molecules present in the matrices that surround them. For example, these can be cues for cells to express specific genes so they can proliferate or differentiate into several types of cells leading to growth or regeneration of tissues. One of the marvels of this signalling machinery is the built-in capacity in living organisms to make signals stop and restart as needed, or to switch off one signal and activate a different one to orchestrate very complex processes.

The new technology manipulates cells by converting the skin cells to cure a patient with Parkinsons disease. (Shutterstock)

Building artificial materials with this type of dynamic capacity for regenerative therapies has been virtually impossible so far. The new work published today reports the development of the first synthetic material that has the capability to trigger reversibly this type of dynamic signalling. The platform could not only lead to materials that manage stem cells for more effective regenerative therapies, but will also allow scientists to explore and discover in the laboratory new ways to control the fate of cells and their functions.

One of the findings is the possibility of using the synthetic material to signal neural stem cells to proliferate, then at a specific time selected by the operator, trigger their differentiation into neurons and then return the stem cells back to a proliferative state on demand. The paper also reports that spinal cord neural stem cells, initially grouped into structures known as neurospheres, can be driven to spread out and differentiate using a signal.

But when this signal is switched off, the cells spontaneously regroup themselves into colonies. This uncovers strong interactions among these cells that could be important in understanding developmental and regenerative cues. The potential use of the new technology to manipulate cells could help cure a patient with 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 in vitro in the lab and then drive their differentiation into dopamine-producing neurons before transplantation back to the patient. In the new technology, materials are chemically decorated with different strands of DNA, each designed to display a different signal to cells.

People would love to have cell therapies that utilize stem cells derived from their own bodies to regenerate tissue. 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, noted Stupp. While this process is currently only done in vitro with the vision of then transplanting cells, Stupp said in the future it might be possible to perform this process in vivo.

The stem cells would be implanted in the clinic, encapsulated in the type of material described in the new work, via an injection and targeted to a particular spot. Then the soluble molecules would be given to the patient to manipulate proliferation and differentiation of transplanted cells. The study was published in journal Nature Communications.

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CReM Stem Cell Researcher Is Innovator of the Year – BU Today

By JoanneRUSSELL25

Those who know ancient historythe first decade of the 21st centuryrecall that embryonic stem cell research was a combustible issue, with supporters cheering the potential to create new tissues from stem cells and opponents decrying the destruction of human embryos that it required. A breakthrough arrived in 2006, when a Japanese researcher developed induced pluripotent stem cells (iPS), adult cells that behaved like embryonic stem cells and had an amazing ability to develop into muscles, skin, nerves, and almost any other cell type. Two years later, a second breakthrough, this one by Gustavo Mostoslavsky, a School of Medicine associate professor of gastroenterology, produced a tool that made it simpler and more efficient to generate iPS. BU patented his tool, called STEMCCA, and he says that its been adopted by more than 700 laboratories worldwide for making iPS.

That contribution to the field has earned Mostoslavsky this years University Innovator of the Year award. The Technology Developmentoffice presents the award to a faculty member whose research yields inventions or innovations benefiting society. Mostoslavsky will receive the award today at BUs annual Tech, Drugs, and Rock n Roll networking event connecting BU researchers and Boston entrepreneurs.

I was humbly surprised and happy, he says, when Gloria Waters, vice president and associate provost for research, emailed him the news. Sometimes it is easy to lose perspective when we get busy on the many tasks of running a labgrant writing, mentoring, budget, and so forthso I guess it is nice, once in a while, to just stop and enjoy the moment, enjoy what we have done so far, and even better, if on the way we have helped many others succeed.

One way Mostoslavsky has helped others succeedthe way that makes him most proud, he saysis to have cofounded, in 2010, BUs Center for Regenerative Medicine, which he codirects. The center, which pursues stem cell research with an emphasis on lung, blood, and gastrointestinal tract diseases, practices open source biology: sharing its discoveries with scientists around the world for free rather than patenting them. In 2013, CReM moved into its own physical quarters on Albany Street on the Medical Campus.

I am delighted to see Dr. Mostoslavskys colleagues choose him for this award, says Waters. STEMCCA has dramatically improved the efficiency with which new stem cells can be generated to treat disease. His success in patenting a tool that has become industry-standard, at the same time as he and the codirectors of the CReM have become renowned for their open source biology, serves as a model to students and other researchers of how to advance science through sharing, at the same time protecting important intellectual property.

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J&J drops stem cell partner Capricor – BioPharma Dive

By Dr. Matthew Watson

Dive Brief:

While the loss of the deal has made a hole on the company's value, Capricor is looking on the bright side.

"Over the last few years, and during the term of the Janssen option period, we believe that significant value for our CAP-1002 asset has been created through the demonstration of clinical proof-of-concept to treat Duchenne muscular dystrophy (DMD) and also from the progress that has been made towards the development of a commercial-scale manufacturing process for the cells," said Linda Marbn, Capricor's president and CEO.

The company also suggested that a potential upside of the loss of the agreements is that it "resolves uncertainty concerning the scope of the license for CAP-1002 and provides Capricor the freedom to enter into new licensing and/or business development opportunities."

Although, as most investors know, it's generally a bad sign when your big pharma partner bails and, typically, hurts prospects for gaining another commercialization partner.

Capricor has faced some challenges in 2017. In February, it pulled out of an agreement with the Mayo Clinic, which included scrapping development of a Phase 2 heart failure drug, cenderitide, in order to focus on cell and exosome-based therapeutics. And then in May, it faced problems with CAP-1002 in the ALLSTAR Phase 1/2 trial. These topline results showed that CAP-1002 had only a small chance of meeting the primary endpoint of significantly reducing cardiac scarring in adults who had had a major heart attack. This resulted in a reduction in the scope of the company's options, including its workforce size.

The focus for this product, which is manufactured from donated heart tissue, is now in young men with Duchenne muscular dystrophy-associated cardiomyopathy, and the HOPE Phase 1/2 trial is ongoing. Six-month results were presented late last month at the 2017 Patient Project Muscular Dystrophy (PPMD) Annual Connect Conference, showing improved cardiac systolic wall thickening, and improved performance of upper limb in treated patients.

"We discussed potential product registration strategies for this indication at our recent meeting with the U.S. Food and Drug Administration. We expect to commence a randomized, double-blind, placebo-controlled clinical trial of repeat administrations of intravenous CAP-1002 in boys and young men with DMD in the second half of this year, subject to regulatory approval," said Marbn.

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Ashli Stempel helped save her brother’s life. She hopes to inspire others. – GazetteNET

By Sykes24Tracey

A few small scars on Ashli Stempels lower back are the only evidence that a drill burrowed into her hipbone last year at Brigham and Womens Hospital in Boston. The surgery was to harvest the stem cells in her bone marrow to save her older brother Andrew Stempels life.

At age 27, Andrew was diagnosed with cancer of the white blood cells called Hodgkins lymphoma. Donating her bone marrow so that Andrews body could manufacture healthy blood cells, was a small price to pay to give him a shot at survival, Ashli says.

Since the transplant last August after years of treatment and testing Andrew has been cancer-free and Ashli now volunteers periodically in their hometown of Greenfield to spread awareness about this life-saving treatment.

Our bodies are a cure for some cancers, says Ashli Stempel on a recent Saturday as she handsout sign-up forms atGreenfields Energy Park for the Be A Matchnational donor registry. If even one person joins the registry that is awesome.

Its a sunnyday and Stempel, 30,wearing a black and white spaghetti-strap dress stands behind a booth smiling and talking to passersby.

Everybody wants to cure cancer, but I think not everybody understands that we, ourselves, can be the cure for some types of cancers, she says. I can say that I killed cancer and I am pretty excited about that.

In the hollow spaces in a bodys bones, stem cells inside the bone marrow tissue work to create red blood cells, which feed oxygen to the organs, and make white blood cells to fight infections. The bone marrow also produces blood platelets to help form clots but when a cancer of the blood like, leukemia or lymphoma strikes, these life-supporting systems are thrown out of whack, leaving the bodys immune system unable to fight diseases, infection or the cancer.

Chemotherapy and radiation also can kill off bone marrow tissue, leaving patients with more damage to their immune systems, says physician assistant Susanne Smith, donor services clinician at Dana-Farber/Brigham and Womens Hospitals Cancer Center in Boston.

When transplanted into a cancer patients bloodstream, stem cells, a precursor to all the immune system cells in the body, colonize the bones and help fight any remaining cancer, says Smith.

In many cases (a transplant) is the only cure for a leukemia or lymphoma diagnosis chemotherapy can only get a patient so far, says Mary Halet, director of community engagement at the Be The Match Registry, the Minneapolis organization that manages the largest bone marrow registry in the world. But first, a patient must find a tissue match, that is, a donor who has a similar protein marker called the human leukocyte antigen, which is found on most cells in the body.

There are up to 14,000 patients every year who could benefit from a bone marrow transplant, but many of these people will not receive a donation, says Halet. In most cases, the patient will not finda tissue match in his or her own family andmust seek help from a stranger, she says. A patients likelihood of finding a matching bone marrow donor ranges from 66 percent to 97 percentdepending on ethnic background. White patients have a 97 percent chance of finding a match, while black patients only find a match 66 percent of the time.The difference reflects the complexity of the tissues makeup and the number of donors.

Thats why Halets organization promotes recruitment events like the one Ashli Stempel held in Greenfield.

Stempel says she was ecstatic when she found out that she was a match for her brother. She was in her late 20s at the time, a bubbly woman working in communications at Smith College in Northampton, who grew up in a close-knit family.

Her brother, who was working as a retail manager in the Boston area, had discovered a bump on his collarbone.

I woke up one morning and there was a non-painful lump, Andrew Stempel says.

He ignored it for as long as he could before seeing a doctor who diagnosed it as a swollen lymph node caused by Hodgkins lymphoma.

Cancer is a very scary word. I think what you learn going through it is that it is not such a scary word, you can survive, says Ashli Stempel.

The Stempel family had seen that firsthand years earlier when Andrew and Ashlis mother, Deborah, recovered from breast cancer.

Still, that didnt lessen the anxiety for Andrew. As soon as the doctor said the word cancer, he says, his life started to unravel with a battery of experimental drugs, chemotherapy and radiation.

In the begining there was a lot of uncertainty, he says.

Even through his cancer went into remission after a year, doctors did not expect it to remain that way without high doses of chemo or radiation. The plan was to do a bone marrow transplant for long-term survival.

Still, using donated bone marrow meant taking the risk that Andrews body would reject it, which could be fatal.

So, doctors first wanted to try using Andrews own tissue. That would require removing some of his bone marrow, treating it and then injecting it back into his bloodstream.

Within months of the procedure, however, Andrews cancer returned, indicating to doctors that his body wasnt strong enough to fight it on its own.

Ashli was tested via a mouth swab and Andrew was relieved to learn that she was a tissue match.

I was just overwhelmed with happiness, he says.

Ashli went through a month-long screening process to ensure that she was healthy enough to be a donor. People who have infectious diseases like HIV or hepatitis cannot be donors, nor can those with immune systems weakened by autoimmune diseases. Doctors also prefer to use bone marrow from young donors under the age of 44, says Halet. The registry wont accept donors over 60.

When we are young, our immune systems are at their healthiest and the older we get the less robust they are, she says.

It took two years from the time Ashli first learned she was a match for her brother for the transplant to take place.

Not long aftershe woke up from the surgery, Ashli saw the bone marrow that had been taken from her, a two-literjug ofmilky, red liquid. It was whisked away to another partof the hospital where it ended up in a drip bag connected to a vein in Andrews arm.

Doctors saw hisred and white blood cell counts go up immediately after the transplant.

My sisters cells were working, he says. It was amazing.

Even though the transplant was a success, Andrew had to stay in the hospital for a month. Chemotherapy had caused sores in his mouth, he lost his ability to taste food along withhis appetiteand he droppednearly 30 pounds.

It was tough, day to day, but progressively got better, he says.

Since he was essentially receiving a new immune system, like a newborn baby he also had to be shielded from germs, says Ashli.

When his wife, Meghan Stempel, came to visit him, she needed to wear a facemask and gloves. Even when he returned home, he had to be careful. Hetook a year off from his job to recover, spending many afternoons resting on the couch watching TV. After spending months working to building hisstrength back up,he says, most of his weakness has subsided.

I feel a thousand times better, he says.

He is now cancer free and is returning to hisjob as a retail managerat Sherwin Williams this week.

Following her operation, Ashli took off a few weeks from her job in communications at Smith College, but was back on her feet within a couple days. Her hips were sore which meant limping around the house for a short time.

I was in pain, of course, she says. But its a quick recovery.

A few weeks ago Ashli decided to signup for the national bone marrow donor registry through Be A Matchto donate for a second time.

Her name will stay in the system for the foreseeable future. A match could come up or it might never.

Maybe I will be called on to do it again, who knows?

To learn more about becoming a bone marrow donor or to sign up for the registry, go tobethematch.org.

Potential donors can fill out an online form and the registry will mail a mouth swab kit, which can be returned by mail.

If called, a potential donor will undergo a series of blood tests which will evaluate the suitabililty and safety of the match. Though doctors say risks are low for donors, possible complications include infection and bleeding.

Once a donor is cleared, the transplant procedure could occur within a few weeks or a few months, depending on a recommendation from the patients doctor.

The bone marrow transplant is an outpatient procedure for the donor.Recovery time is only a few days anddonors are typically back to their normal routine in two to seven days.

Donors are told their commitment means being willing to devote up to 30 hours spread over four to six weeks to attend appointments and give the donation.

All medical costs for the donation procedure are covered by the National Marrow Donor Program, which operates the Be The Match Registry, or by the cancer patients medical insurance.

Sometime travel is required. Most travel expenses are covered by Be The Match.

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Clinical trial for stem-cell therapy to reverse liver cirrhosis – The Straits Times

By JoanneRUSSELL25

SINGAPORE - The use of stem cells to reverse liver cirrhosis - or the hardening of the liver - is being explored in a clinical trial.

Conducted by a multi-centre team led by the National University Hospital (NUH), doctors aim to determine if stem cell therapy can improve liver function.

Previously, liver cirrhosis, caused by various diseases such as chronic hepatitis B and non-alcoholic fatty liver disease, was thought to be irreversible.

A liver transplant provides a definitive cure to end-stage cirrhosis.

However, in Singapore, less than 5 per cent of end-stage liver cirrhosis patients receive a liver transplant.

The number of people on the waiting list for a liver transplant has been increasing over the years, according to statistics from the Ministry of Health.

In 2007, there were nine on the waiting list, compared with 57 last year. There are around 50 waiting for a liver transplant this year.

Also, many patients do not fulfil the eligibility criteria to receive a liver transplant due to other health complications or being above the age limit of 70 years.

The $2.6 million study, which was launched on Tuesday (July 11),is funded by the National Medical Research Counciland 46 patients will be recruited for it. It will run for four years and patients will not need to bear the costs of the stem cell treatment.

Stem cells will be taken from a patient's own bone marrow and will be isolated and injected directly into the patient's liver to initiate the repair.

Similar therapy treatments have been conducted overseas in countries such asEgypt and India, although they have not been fully evaluated for efficacy.

Associate Professor Dan Yock Young, a senior consultant in the division of gastroenterology and hepatology at NUH, said: "We are conducting the study in a systematic and scientific mannerto get definitive evidence of the effects of the treatment."

He also notes that the stem cell therapy is not a substitute for a liver transplant. "This treatment is not intended to pull patients off the waiting list, but provide an option for those who are not eligible for a transplant."

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Researchers are closer to working capillaries in 3D-printed organs – Engadget

By raymumme

All of our blood vessels are lined with a type of cell called endothelial cells. To form vessels, individual endothelial cells begin to create empty holes in themselves, called vacuoles. They then connect with other endothelial cells that have done the same thing and the linked vacuoles form tubes, which ultimately become capillaries. Here, the researchers took endothelial cells and mixed them with either fibrin -- a protein involved in blood clotting -- or a semi-synthetic material called gelatin methacrylate (GelMA), which can be easily 3D-printed. When mixed with fibrin, the endothelial cells formed tubes fairly easily, but that wasn't the case with the GelMA. However, when the researchers added in another type of cell, a stem cell found in bone marrow, the endothelial cells were then able to form tubes in the GelMA.

"We've confirmed that these cells have the capacity to form capillary-like structures, both in a natural material called fibrin and in a semi-synthetic material called gelatin methacrylate, or GelMA," Gisele Calderon, the lead author of the study, said in a statement, "The GelMA finding is particularly interesting because it is something we can readily 3D print for future tissue-engineering applications."

The benefits of this method over others include cells that can be patient-specific, reducing the risk of immune system complications, and growth environments that are well suited for organ and vasculature growth -- they're reproducible, not likely to induce immune responses and help boost cell growth and vessel development. Along with making 3D-printed organs more viable, this method will also allow for the development of tissue that could make for more effective and efficient drug testing. In a statement, Jordan Miller, whose lab the work was done in, said, "Preclinical human testing of new drugs today is done with flat two-dimensional human tissue cultures. But it is well-known that cells often behave differently in three-dimensional tissues than they do in two-dimensional cultures. There's hope that testing drugs in more realistic three-dimensional cultures will lower overall drug development costs."

You can watch a video of the cells beginning to form tubes here and Calderon explaining her work in the video below.

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Stem cell-based therapy for targeting skin-to-brain cancer – Medical Xpress

By raymumme

July 10, 2017 Credit: CC0 Public Domain

Investigators from Brigham and Women's Hospital (BWH) and the Harvard Stem Cell Institute have a potential solution for how to kill tumor cells that have metastasized to the brain. The team has developed cancer-killing viruses that can deliver stem cells via the carotid artery, and applied them to metastatic tumors in the brain of clinically relevant mouse models. The investigators report the elimination of metastatic skin cancer cells from the brain of these preclinical models, resulting in prolonged survival. The study, published online this week in the journal PNAS, also describes a strategy of combining this therapy with immune check point inhibitors.

"Metastatic brain tumors - often from lung, breast or skin cancers - are the most commonly observed tumors within the brain and account for about 40 percent of advanced melanoma metastases. Current therapeutic options for such patients are limited, particularly when there are many metastases," says Khalid Shah, MS, PhD, director of the Center for Stem Cell Therapeutics and Imaging (CSTI) in the BWH Department of Neurosurgery, who led the study. "Our results are the first to provide insight into ways of targeting multiple brain metastatic deposits with stem-cell-loaded oncolytic viruses that specifically kill dividing tumor cells."

In their search for novel, tumor-specific therapies that could target multiple brain metastases without damaging adjacent tissues, the research team first developed different BRAF wild type and mutant mouse models that more closely mimic what is seen in patients. They found that injecting patient-derived, brain-seeking melanoma cells into the carotid artery of these preclinical models resulted in the formation of many metastatic tumors throughout the brain, mimicking what is seen in advanced melanoma cancer patients. The injected cells express markers that allow them to enter the brain and are labelled with bioluminescent and fluorescent markers to enable tracking by imaging technologies.

To devise a potential new therapy, the investigators engineered a population of bone marrow derived mesenchymal stem cells loaded with oncolytic herpes simplex virus (oHSV), which specifically kills dividing cancer cells while sparing normal cells. Previous research by Shah and his colleagues shows that different stem cell types are naturally attracted toward tumors in the brain. After first verifying that stem cells injected to the brain would travel to multiple metastatic sites and not to tumor-free areas in their model, the team injected stem cells loaded with oHSV into the carotid artery of metastasis-bearing mice.. Injecting the stem cells loaded with oHSV into the carotid artery, a likely strategy for clinical application, led to significantly slower tumor growth and increased survival, compared with the models that received unaltered stem cells or control injections. The oHSV loaded stem cells are ultimately killed by oHSV mediated oncolysis, preventing the engineered cells from persisting within the brain, which is an important safety component in the therapeutic use of these stem cells.

Due to an increasing body of evidence which suggests that the host immune response may be critical to the efficacy of oncolytic virotherapy, Shah and his colleagues also developed an immunocompetent melanoma mouse model and explored treating with both stem cell loaded oHSV and immune checkpoint blockers such as the ones that target the PD-1/PD-L1 pathway. They found that PD-L1 immune checkpoint blockade significantly improved the therapeutic efficacy of stem cell based oncolytic virotherapy in melanoma brain metastasis.

"We are currently developing similar animal models of brain metastasis from other cancer types as well as new oncolytic viruses that have the ability to specifically kill a wide variety of resistant tumor cells," said Shah, who is also a professor at Harvard Medical School and a principal faculty member at the Harvard Stem Cell Institute. "We are hopeful that our findings will overcome problems associated with current clinical procedures. This work will have direct implications for designing clinical trials using oncolytic viruses for metastatic tumors in the brain."

Explore further: Stem-cell-based therapy promising for treatment of breast cancer metastases in the brain

More information: Wanlu Du el al., "In vivo imaging of the fate and therapeutic efficacy of stem cell-loaded oncolytic herpes simplex virus in advanced melanoma," PNAS (2017). http://www.pnas.org/cgi/doi/10.1073/pnas.1700363114

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Stem Cell Treatments in Use at Clinics Worldwide Need Regulation … – Multiple Sclerosis News Today

By LizaAVILA

Advertising forstem cell therapies not supported by clinical researchoftenmadedirectly to patients and sometimes promoted as a cure for diseases like multiple sclerosis or Parkinsons is a growing problem that needs to be addressed and regulated, a team of leading experts say, calling suchstem cell tourism potentially unsafe.

Stem cell tourism is the unflattering name given to the practice of encouragingpatients totravel outside their home country to undergo suchtreatment, typicaly at a private clinic.

The article, titledMarketing of unproven stem cellbased interventions: A call to actionandrecently published inthe journal Science Translational Medicine, was co-authored by scientistswith universities and hospitals in the U.S., Canada, U.K., Belgium, Italy, Japan, and Australia. It focuses on the global problem of thecommercial promotion of stem cell therapies and ongoing resistance to regulatory efforts.

Its authors suggest that a coordinated approach, at national and international levels, be focused on engagement, harmonization, and enforcement in order to reduce risks associated with direct-to-consumer marketing of unproven stem cell treatments.

Treatments involving stem cell transplants are now being offered by hundreds of medical institutions worldwide, claiming efficacy in repairing tissue damaged by degenerative disorders like MS, even thoughthose claim often lack or are supported bylittle evidence .

They alsonoted that the continued availability of these treatments undermines the development of rigorously tested therapies, and potentially canendanger a patients life.

The researchers emphasizethat tighter regulations on stem cell therapy advertising are needed, especiallyregarding potential clinical benefits. They support the establishment ofinternational regulatory standards for the manufacture and testing of human cell and tissue-based therapies.

Many patients feel that potential cures are being held back by red tape and lengthy approval processes. Although this can be frustrating, these procedures are there to protect patients from undergoing needless treatments that could put their lives at risk, Sarah Chan, a University of Edinburgh Chancellors Fellow and report co-author, saidin anews release.

Chan and her colleagues are also calling for the World Health Organization to offer guidance on responsible clinical use of cells and tissues, as it does for medicines and medical devices.

Stem cell therapies hold a lot of promise, Chan said, but we need rigorous clinical trials and regulatory processes to determine whether a proposed treatment is safe, effective and better than existing treatments.

According to the release, the report and its recommendationsfollowed the death of two children at a German clinic in 2010. The clinichas since been shut down.

Certainstem cell therapies mostly involving blood and skin stem cells have undergone rigorous testing in clinical trials, the researchers noted. A number of theseresulted in aprovedtreatments for certain blood cancers, and to grow skin grafts for patients with severe burns.

Information about the current status of stem cell research andpotential uses of stem cell therapiesis availableon the websiteEuroStemCell.

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Medical Tourism in Spotlight as Experts Call for Tighter Regulation – Bioscience Technology

By Dr. Matthew Watson

Countries should unite to tackle unscrupulous advertising of unproven therapies involving stem cells, experts say.

An international group of leading experts has called for tighter regulation of so-called stem cell tourism. This involves patients travelling to other countries, where medical regulations are less strict, for treatment with potentially unsafe therapies.

Hundreds of medical centres around the world are offering therapies that involve transplantation of so-called stem cells -- which they claim have the ability to repair damaged tissues. Clinics are marketing the treatment for a range of conditions, including multiple sclerosis and Parkinson's disease.

Often these therapies are advertised directly to patients with the promise of a cure. But experts say there is often no evidence to show that the treatments will help anyone, or will not cause harm.

Researchers say the practice risks undermining the development of rigorously tested, validated therapies and puts lives at risk.

Writing in the journal Science Translational Medicine, the group has called for coordinated global action to tackle the problem.

They say tighter regulations on advertising stem cell therapies are needed, so that unsupported claims about potential clinical benefits do not go unchallenged.

Global regulatory authorities should agree international standards for the manufacture and testing of cell and tissue-based therapies, they add.

The group -- which includes experts from the University of Edinburgh -- also calls for the World Health Organization to help guide responsible clinical use of cells and tissues, as it does for medicines and medicinal devices.

Their appeal follows the deaths of two children at a clinic in Germany in 2010, which exploited a legal loophole to offer untested treatments. The clinic has since been closed.

Dr. Sarah Chan, a Chancellor's Fellow at the University of Edinburgh, said: "Many patients feel that potential cures are being held back by red tape and lengthy approval processes. Although this can be frustrating, these procedures are there to protect patients from undergoing needless treatments that could put their lives at risk.

"Stem cell therapies hold a lot of promise but we need rigorous clinical trials and regulatory processes to determine whether a proposed treatment is safe, effective and better than existing treatments."

Some types of stem cell transplantation - mainly blood and skin stem cells -- have been approved to treat certain types of cancer and to grow skin grafts for patients with severe burns. These treatments have been rigorously tested in clinical trials.

SOURCE: University of Edinburgh

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Asterias Biotherapeutics Receives FDA Clearance to Enroll C-4 Patients in SCiStar Study – PR Newswire (press release)

By NEVAGiles23

"The FDA's decision to allow Asterias to enroll qualified patients with C-4 level injuries is the result of the data supporting the safety of both AST-OPC1 and the procedure to inject the cells, and means that the second most common cervical spinal cord injury population can now be eligible to receive AST-OPC1," said Dr. Edward Wirth, Chief Medical Officer of Asterias. "The overall changes to the study protocol will enhance our ability to enroll qualified patient candidates for our current SCiStar study and we also expect the changes to help enrollment rates in a future, larger clinical study."

The protocol amendment will expand patient eligibility and enable study investigators to administer AST-OPC1 to patients with injuries at one vertebral level higher than the trial's previous C-5 limitation, to the fourth cervical vertebra down, known as C-4, near the middle of the neck. A C-4 cervical level injury, the second most common level of SCI in the SCiStar study's targeted patient population, generally means that the injured person is paralyzed from the neck down and requires round-the-clock care. The lifetime direct costs of care for a patient suffering a high cervical spinal cord injury, such as a C-4 spinal cord injury, can approach $5 million. As suggested by existing research, if these patients can show two motor levels of improvement on at least one side they may regain the ability to perform daily activities such as feeding, dressing and bathing, which increases their quality of life and independence and significantly reduces the overall level of required daily assistance and associated healthcare costs for these patients.

In addition, the amendment to inclusion parameters will also expand the dosing window to 21 to 42 days after a patient's spinal cord injury occurs, providing study investigators more time to screen patients to determine if they are eligible to participate in the SCiStar study. The expansion of the dosing window is supported by recent preclinical research that indicated AST-OPC1 cells can durably engraft at a patient's injury site when administered up to two months after the date of injury.

About the SCiStar Trial

The SCiStar trial is an open-label, single-arm trial testing three sequential escalating doses of AST-OPC1 administered at up to 20 million AST-OPC1 cells in as many as 35 patients with subacute, C-4 to C-7, motor complete (AIS-A or AIS-B) cervical SCI. These individuals have essentially lost all movement below their injury site and experience severe paralysis of the upper and lower limbs. AIS-A patients have lost all motor and sensory function below their injury site, while AIS-B patients have lost all motor function but may have retained some minimal sensory function below their injury site. AST-OPC1 is being administered 21 to 42 days post-injury. Patients will be followed by neurological exams and imaging procedures to assess the safety and activity of the product.

The study is being conducted at six centers in the U.S. and the company plans to increase this to up to 12 sites to accommodate the expanded patient enrollment. Clinical sites involved in the study include the Medical College of Wisconsin in Milwaukee, Shepherd Medical Center in Atlanta, University of Southern California (USC) jointly with Rancho Los Amigos National Rehabilitation Center in Los Angeles, Indiana University, Rush University Medical Center in Chicago and Santa Clara Valley Medical Center in San Jose jointly with Stanford University.

Asterias has received a Strategic Partnerships Award grant from the California Institute for Regenerative Medicine, which provides $14.3 million of non-dilutive funding for the Phase 1/2a clinical trial and other product development activities for AST-OPC1.

Additional information on the Phase 1/2a trial, including trial sites, can be found at http://www.clinicaltrials.gov, using Identifier NCT02302157, and at the SCiStar Study Website (www.SCiStar-study.com).

About AST-OPC1

AST-OPC1, an oligodendrocyte progenitor population derived from human embryonic stem cells originally isolated in 1998, has been shown in animals and in vitro to have three potentially reparative functions that address the complex pathologies observed at the injury site of a spinal cord injury. These activities of AST-OPC1 include production of neurotrophic factors, stimulation of vascularization, and induction of remyelination of denuded axons, all of which are critical for survival, regrowth and conduction of nerve impulses through axons at the injury site. In preclinical animal testing, AST-OPC1 administration led to remyelination of axons, improved hindlimb and forelimb locomotor function, dramatic reductions in injury-related cavitation and significant preservation of myelinated axons traversing the injury site.

In a previous Phase 1 clinical trial, five patients with neurologically complete, thoracic spinal cord injury were administered two million AST-OPC1 cells at the spinal cord injury site 7-14 days post-injury. Based on the results of this study, Asterias received clearance from FDA to progress testing of AST-OPC1 to patients with cervical spine injuries in the current SCiStar study, which represents the first targeted population for registration trials. Asterias has completed enrollment in the first two cohorts of this study. Results to date have continued to support the safety of AST-OPC1, with no serious adverse events related to AST-OPC1 or its administration. Additionally, Asterias has recently reported results suggesting reduced cavitation and improved motor function in patients administered AST-OPC1 in the SCiStar trial.

About Asterias Biotherapeutics

Asterias Biotherapeutics, Inc. is a biotechnology company pioneering the field of regenerative medicine. The company's proprietary cell therapy programs are based on its pluripotent stem cell and immunotherapy platform technologies. Asterias is presently focused on advancing three clinical-stage programs which have the potential to address areas of very high unmet medical need in the fields of neurology and oncology. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. AST-VAC1 (antigen-presenting autologous dendritic cells) is undergoing continuing development by Asterias based on promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML), with current efforts focused on streamlining and modernizing the manufacturing process. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic cancer immunotherapy. The company's research partner, Cancer Research UK, plans to begin a Phase 1/2a clinical trial of AST-VAC2 in non-small cell lung cancer in 2017. Additional information about Asterias can be found at http://www.asteriasbiotherapeutics.com.

FORWARD-LOOKING STATEMENTS

Statements pertaining to future financial and/or operating and/or clinical research results, future growth in research, technology, clinical development, and potential opportunities for Asterias, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Asterias, particularly those mentioned in the cautionary statements found in Asterias' filings with the Securities and Exchange Commission. Asterias disclaims any intent or obligation to update these forward-looking statements.

View original content:http://www.prnewswire.com/news-releases/asterias-biotherapeutics-receives-fda-clearance-to-enroll-c-4-patients-in-scistar-study-300485009.html

SOURCE Asterias Biotherapeutics, Inc.

http://www.asteriasbiotherapeutics.com

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Asterias Biotherapeutics Receives FDA Clearance to Enroll C-4 Patients in SCiStar Study - PR Newswire (press release)

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Ventolin proair – Rsv breathing treatments albuterol – Van Wert independent

By LizaAVILA

VW independent/submitted information

DELPHOS A Delphos couple were injured in a home invasion assault that occurred Saturday morning.

David and Dianna Allemeier of 209 S. Pierce St. in Delphos were both taken to St. Ritas Medical Center in Lima for treatment of injuries received when a man gained entry to their home and reportedly assaulted them.

Delphos Police were first called out at 6:05 a.m. Saturday on a report of a suspicious person in the 300 block of Jackson Street who was knocking on doors and then walking away. However, while en route to that call, officers were informed that a man had been injured and was bleeding in the 200 block of Pierce Street.

When officers arrived on the scene, they found Allemeier bleeding from an injury to his neck. The Delphos resident said he received the injury from a man who had gained entry into his home.

Officers approached the residence and found the back door unlocked and a lot of blood at the scene. The home was secured and a K-9 and Crime Scene Unit sought from the Allen County Sheriffs Office.

Allemeier then said his wife was still in the house and officers then entered and found Mrs. Allemeier, who was also injured, in the bedroom area of the residence.

After the Allemeiers were transported to the hospital, a K-9 search was made of the area, and the house was processed by an Allen County sheriffs deputy.

No information was released on whether items were taken from the Allemeier house.

Police are currently seeking a young, skinny white male with black hair, possibly wearing cutoff shorts. Anyone with information is asked to contact the Delphos Police Department or Allen County Sheriffs Office.

The investigation is continuing, with no further information forthcoming at this time.

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Treatment of Scars with Stem Cells :: Stem Cell Skin …

By raymumme

At a Glance

Schedule appointment or Skype information

We know from experience that patients having scars find them particularly unattractive and mentally stressful. Scars form after wounds have finished healing, when deeper skin layers have been injured. Skin injuries can be caused by an accident, a skin disease or burns. So-called pregnancy stretch marks are also scars.

At first, scars will be red due to the large number of blood vessels. The scar tissue then gradually lightens in color, because the amount of collagenous fibers increases over time. From a medical point of view, scar tissue is an inferior kind of tissue and if put under a certain amount of pressure, so-called scar hernias can be a result thereof.

The formation of scars cannot be prevented after the deeper skin layers have been injured. The chances of the scar healing without too many traces increase, if the wound is treated well during the healing process.

If your wound healing process is already completed and scar tissue has formed, further treatment depends on the cause of the injury and type of scarring. In any case, we require your autologous stem cells obtained from your body fat. It is necessary to extract a small amount of your bodys own fat in order to obtain the stem cells. In accordance with your wishes, liposuction is carried out with microcannulas or regular cannulas.

The question as to whether the scars will be treated with stem cells only or if scar tissue has to be removed depends on the scar itself:

Post-surgery care is minimal: Treatment is on an outpatient basis; afterwards, you are fully mobile and normally can go back to work without any restrictions. We will provide you with individual recommendations for your post-treatment care according to the extent and type of area treated and will give you support during the healing process.

Schedule consultation appointment

Last updated: February 24, 2015

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Dad set to undergo gruelling chemotherapy to kill his immune system despite not having cancer in bid walk again – Mirror.co.uk

By Dr. Matthew Watson

A father of two has taken the decision to undergo chemotherapy, despite not having cancer.

Roy Palmer lost the use of his legs 12 years ago as a result of his multiple sclerosis and has been seeking successful treatment ever since.

But it was while watching Panorama that the 48-year-old realised a combination of stem cell treatment and chemotherapy could be the answer he was looking for, GloucestershireLive reports.

The latter is strongly associated with cancer treatment , but its properties in rendering the body's immune system almost useless are a key part of the stem cell programme Roy hopes will see him up and about again.

He and his wife Helen decided they needed to make some calls and get appointments organised to be able to try and get this pioneering treatment going.

The onset of MS in Roy's case had been swift. In less than a week what began as pins and needles ended with him having no use of his legs.

Even with intense physiotherapy and a combination of steroids and drugs Roy relapsed several times and has been off his feet for 12 years. However when he saw the treatment that is out there, in a Panorama documentary, he and his wife cried.

Roy, 48, said: I just couldnt believe what I was seeing, the stories that I saw on the programme about how well people have been doing and the stem cell treatment actually worked.

I am really pleased that I am going to be able to start the treatment. I lost the use of my legs in 2005. I was encouraged by another woman that has been through it and she was in a wheelchair and now walking.

In the process to have treatment Ive had so many knockbacks being told that I did not fit the criteria but now I am finally getting the treatment.

His treatment will see him travel to the Imperial College Hospital in Hammersmith where a course of drugs will be administered to draw stem cells from Roy's bones into his bloodstream. Over a course of time, those stem cells will then transfer to a pack similar to a blood transfusion bag and be frozen.

It is then that Roy will undergo an intensive course of chemotherapy to render his immune system virtually useless - so much so he will live in isolation for four to six weeks to minimise risk of infection.

The treatment is called HSCT. The MS Society website states that: 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 rebuild the immune system using a type of stem cell found in your bone marrow.

Roy's wife Helen, 45, said: After the chemo they will reintroduce the stem cells, and because his body will be at zero, it will be rebooted and the MS stopped in its tracks.

Roy has been on lots of different drugs over the years and his body has gradually got used to them and they stop working.

Roy has suffered with his hands not working properly and blurred vision which they call a brain fog. His legs ceasing to work has been a huge set-back for Roy as he used to work as a courier.

Roy said: I want to be able to get out the door without having to use the ramp, it is not a huge deal to anyone else but it is to me.

My goal now is to be able to reach the end point and be able to walk again.

Roy and Helen have two children Jack, 21 and Abigail, 12, and they are fully supportive of their fathers treatment.

Helen said: I am really pleased that we went to see the GP to get this going. Roy was desperate for this treatment.

It is difficult and my father is travelling from Wales to come and look after the children and I am really grateful to that.

The children are really supportive of their dads treatment and look forward to him coming out the other side.

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Christchurch MS patient Andrea Cameron-Hill plans Russia trip for stem cell treatment – The Press

By daniellenierenberg

JOEL INESON

Last updated14:01, July 9 2017

IAIN MCGREGOR/Stuff.co.nz

Andrea Cameron-Hill has lived with multiple sclerosis for about 10 years. She wants to receive treatment in Russia that could stop the disease.

Andrea Cameron-Hill thought having to lift her leg to get in the carwhile pregnant was part of carrying twins.

About 10 weeks after they were born she learned she had multiple sclerosis (MS).

"To start with, you wouldn't know I had MS at all. But now it's 10 years on and I'm having to walk with a crutch," she said.

IAIN MCGREGOR/STUFF

MS sufferer Cameron-Hill wants to receive treatment that could stop the disease in its tracks but, despite it being offered here to treat some cancer, must travel to Russia to get it.

"If I have to go down to the floor to load the fire with wood, the difficulty for me now is getting off the floor."

READ MORE: *Multiple sclerosis sufferer Royce Brewer cleared after experimental treatment in Russia *Multiple sclerosis patient to receive 'experimental' treatment in Russia *Friends rallying to help Upper Hutt woman reach Mexico for stem cell treatment *Marlborough woman's search for cure *Plea to help fund stem-cell treatment for Andrea Campbell *Hunt after cure for MS disease

Cameron-Hill has injured her shoulder fromfalls and reliedon her husband, Paul, and sons Lachlanand Oliverto help with household chores.

IAIN MCGREGOR/STUFF

Normal household chores like washing are a challenge because of the debilitating condition.

She wanted to do things like go onto the rugby field while her childrenplayed, but MS meant she had to watch from the car.

"We've got a basketball hoop [at home], which they quite like playing, but they normally play with Grandma because I can't."

"I feel like a spectator in their lives. I hate it. I hate it with a passion."

IAIN MCGREGOR/STUFF

Cameron-Hill's sons, Lachlan and Oliver, pictured, help her complete tasks many do effortlessly.

Cameron-Hill's condition drove herto look at a treatmentused in New Zealand for some forms of cancer, but not available for MS.

She plans to head to Russia for undergohematopoieticstem cell transplantation (HSCT).

HSCT would remove, purifyand concentrate her stem cells.Chemotherapy would wipeher immune system before the stem cells were returned. An extended period of recovery would follow.

IAIN MCGREGOR/STUFF

Cameron-Hill wants to take part in her children's lives, rather than watch from the sidelines.

Cameron-Hill mustraise about $80,000 to get the treatment.So far about $10,000 has been raised through fundraising events and aGivealittlepage.

Leading New Zealand neurologist Dr Deborah Mason said HSCT wasunlikely to be trialledin New Zealand because it wouldnot make drug companies money.

Treatment for MSin New Zealandreliesonimmunosuppressantdrugs.HSCTwaslikened more to a surgical procedure than drug treatment.

"It's incredibly expensive ... We're very keen to participate in [trials and research] and I'd certainly enroll patients, but it's just finding somebody who would fund that, and nobody will because there's no drug involved," Mason said.

Mason saidHSCT might help young patients in the early stages of MS.

She said the treatment was "unproven" and came with risks.

"It's really hard to imagine why I get all these calls about bone marrow transplants ... all bone marrow transplant allows us to [do is] give industrial doses of chemotherapy."

"People talk aboutrebootingthe immune system and all of that. There isn't a lot of proof of that."

Mason knew of about six or seven people who had travelled forHSCT, but did not have a lot of follow-updata.

Studies and clinical trials New Zealanders took part in primarily focussed on medication.

Her "big beef" was with the government not allowing the use of some drugs, "which we absolutely know will benefit the patients".

The Multiple Sclerosis Society of New Zealand recently changed its standpoint on HSCTafter a report indicated the treatment workedfor some with MS in Australia and the UK.

Vice president Neil Woodhams said the group asked the Ministry of Health to start a process to lead to eligible people havingHSCTin New Zealand.

Cameron-Hill's MS had not progressed since 2013and she had not been on medication for it since.

She recently met Christchurch manRoyce Brewer who lived with MS for about 20 years. After undergoing HSCT in Russia in early 2016, hereturned to work as a landscaper at the end of the year.

"I'd just really love to be able to do ... normal stuff that parents do with their kids," Cameron-Hill said.

The Health Research Council of New Zealandhad not funded any research regarding MS andHSCT, a spokeswoman said.

-Stuff

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Stem Cell Therapy: You can be sexually active again – Vanguard … – Vanguard

By JoanneRUSSELL25

By David Ikudayisi

Stem Cell Therapy comes in different types. Embryonic Stem Cell Therapy involves the use of embryonic stem cells derived from the inner cell mass of a blastocyst, an early-stage pre-implantation embryo at 4 days old to around 12 days old, leading to the destruction of the blastocyst which raises ethical and religious issues. Therefore, this type of Stem Cell Therapy is not the focus of this piece. The focus is Adult Stem Cells (ADSCs) and Induced Pluripotent Stem Cells (iPSCs). iPSCs are produced in the laboratories by reprogramming adult cells to express embryonic stem cells characteristics whereas ADSCs are cells obtained from an adult patient who will also be the recipient of the same stem cells.

In the United States, we must transplant the cells back to the same patient on the same day, while in some countries, the stem cells can be cultured to increase the quantity of stem cells before transplanting them back to the same patient who donated them.

Stem Cell Transplantation is a complex process that needs the care of experts in Regenerative Medicine, a new speciality of medicine . In order to ensure that science remains as the vehicle for hope and not harm, the controversies associated with the legal, social and legal issues of certain areas of stem cells research and stem cells potential clinical applications must be carefully examined. Advancing treatment and care for patients to save a life is and must be the ultimate goal.

Regenerative Medicine helps people to naturally regenerate and rejuvenate their bodies from the different conditions they may be suffering from without using chemicals or the orthodox medicine we are used to, but Adult Stem Cells Platelet Rich Plasma (PRP), that is, blood plasma that has been enriched with platelets, and contains growth factors which may elicit the gathering of stem cells around the damaged region stimulating cellular proliferation and tissue regeneration. PRP can be used to promote healing of injured tendons, ligaments, muscles, joints and can be applied to various musculoskeletal problems. The process allows your own (autologous) stem cells to be re-introduced into/around areas of damage or chronic disease. As mentioned earlier, the extraction and transplantation of the stem cells are done on the same day in the United States. Bone marrow transplant has been the most widely used Stem Cell Therapy till date, but Adult Adipose-Derived (fat) Stem Cell Therapy is fast gaining popularity as fat harvesting is less invasive than bone marrow harvesting. You get more stem cells from fat than bone marrow, and fat stem cells are not age-dependent. Adult Stem Cell Therapy may hold answers to many questions and problems that we doctors believed had no solutions, especially neurological disorders. The therapy, with or without PRP, revitalizes and regenerates the body organs and systems; it also reverses and repairs many pending subclinical medical problems before they become apparent, including the diseases that are age-related. Generally, Adult Stem Cell Therapy is safe as shown by many published research reports and clinical trials. However, this does not guarantee that adverse effects cant occur if the treatment is done by physicians that are not properly trained.

The therapy has helped a lot of people all over the world to regain their lives from debilitating ailments and Nigerians are not left behind. There are people in Nigeria that were either wheelchair bound and walking with occasional use of a cane before but now walking without one; diabetes patients are able to have restoration of vision in their eyes, and some feel and look younger. It has helped chronic kidney disease patients in Nigeria that are on hemodialysis to either reduce the frequency of hemodialysis per week or like a patient that was recommended to have kidney transplant a year ago but who is now off hemodialysis and off diabetic medications, and remains stable for the past months. Men with Erectile Dysfunction are now feeling like young men again. I cannot but mention that the type of treatment protocol and dosage of stem cells used also play a role in the efficacy of the treatment, and not everyone will respond in the same manner. Most of the patients, in studies, showed improvements after the first treatment, and the few that needed second treatment went on to see great results after more treatments were done; needless to say that they were elated with the results. The only group of patients that will always need more than a couple of transplantation sessions are patients with neurological disorders. Latest researches and evidence-based studies showed the number of treatment sessions needed to get significant clinical results can decrease by adding Exosomes to the treatment sessions.

In a recently publication in Germany, the new concept, developed around 2010 of how stem cells works, was reinforced where it stated that most of the effects of stem cells are through the Paracrine effects, delivered by the Exosomes. Exosomes are extracellular cell-derived vesicles that are present in almost all biological fluids. When secreted by stem cells, Exosomes are those tiny communication vesicles that interact with surrounding cells, thereby creating therapeutic activity. This is called the Paracrine effect. The Paracrine soluble factors (communication vesicles) have specialized functions and play a key role in intercellular signaling and in the following properties immune modulatory, neuroprotective, anti-inflammatory, neurotrophic, angiotrophic, anti-apoptotic and anti-oxidatory. Stem cells also secrete other important proteins and cytokines that have healing properties.

There are some diseases that conventional treatments have no cure for, but Adult Stem Cell Therapy can reverse the symptoms of those diseases, repair and regenerate the damaged tissues or organs affected. In some cases, it significantly slows down the progression of the disorder. For example, it can regenerate the bony joints in arthritis, repair and strengthen partial rotator cuff tears and avascular necrosis of the hip without surgery, revitalize the sexual organs in men and women, regenerate renal cells in kidney diseases, modulate immune system without use of medications that have very serious side effects in conditions like Rheumatoid Arthritis, Lupus, Scleroderma, Crohns disease, etc. Another advantage is its application in neurological disorders like ALS and spinal cord injury.

Adult Stem Cell Therapy can gradually lower diabetic medications dosage and eventually may get the patients off diabetic medications. This is evidenced by stem cells in a hyperglycemic medium differentiating into pancreatic cells; therefore leading to increased development of new blood vessels, secretion of various products of the immune system, and upregulation of pancreatic transcription factors and vascular growth factor. This aids the pancreas to regenerate and boost its ability to produce insulin. In stroke patients, stem cells activate cells around the suffering brain tissue to catalyze rapid healing and to improve brain function, thereby restoring motor function. Until recently, it was believed that damage to the brain tissue was permanent. This is being challenged by the evidences of re-growth of brain cells and improvements of neurological function documented with the use of Adult Stem Cells.

A procedure called P-Shot for Men uses the PRP Therapy to resolve challenges relating to Erectile Dysfunction by regenerating the damaged tissues. It gives treated men the possibility of saving their relationships by increasing stamina, enjoying bigger and harder genitals, and eventually increasing the length and girth. Orgasm-Shot for Women, the regenerative medicine procedure for womens sexual function, leads to increased ability to have orgasm, better arousal from clitoris stimulation, decreased pain during intercourse, tighter vaginal opening, increased sexual desire and natural lubrication, and increased arousal from G-spot stimulation. In addition, because of the O-Shot rejuvenation capabilities, there is help available for women suffering from urinary stress incontinence without the need for invasive surgery.

Since the stem cells used are autologous, there is no risk of rejection of the stem cell transplant. Nevertheless, as with any procedure, there is a risk of infection which can be very minimal or non-existent if done under the right conditions. Adult Stem Cells Transplantation can also be considered by people looking for alternative treatments especially in the areas of diabetes, hypertension, kidney disease, female and male sexual dysfunction, joint pain, neurological disorder and autoimmune disease. The cost of treatment varies, and it is not for everyone. However, you cant place a price tag on life just as the saying goes that health is wealth.

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Private clinics are peddling untested stem cell treatments it’s unethical and dangerous – Yahoo News UK

By LizaAVILA

Getty Images/Spencer Platt

Stem cell science is an area of medical research that continues to offer great promise. But as this weeks paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, are exploiting regulatory gaps to sell so-called stem cell treatments without evidence that what they offer is effective or even safe.

Such unregulated direct-to-consumer advertising typically of cells obtained using liposuction-like methods not only places the health of individuals at risk, but could also undermine the legitimate development of stem cell-based therapies.

Many academic societies and professional medical organisations have raised concerns about these futile and often expensive cell therapies. Despite this, national regulators have typically been slow or ineffective in curtailing them.

As well as tighter regulations here, international regulators such as the World Health Organisation and the International Council on Harmonisation need to move on ensuring patients desperate for cures arent sold treatments with limited efficacy and unknown safety.

Hundreds of stem cell clinics post online claims that they have been able to treat patients suffering from a wide range of conditions. These include osteoarthritis, pain, spinal cord injury, multiple sclerosis, diabetes and infertility. The websites are high on rhetoric of science often using various accreditation, awards and other tokens to imply legitimacy but low on proof that they work.

osteoporosis strong bones workout old lady

Donna McWilliam/APRather than producing independently verified results, these clinics rely on patient testimonials or unsubstantiated claims of improvement. In so doing these shonky clinics understate the risks to patient health associated with these unproven stem cell-based interventions.

Properly administered informed consent is often overlooked or ignored, so patients can be misled about the likelihood of success. In addition to heavy financial burdens imposed on patients and their families, there is often an opportunity cost because the time wasted in receiving futile stem cells diverts patients away from proven medicines.

The many recent reports of adverse outcomes demonstrate the risks of receiving unproven cell therapies are not trivial. In the USA three women were blinded following experimental stem cell treatment for macular degeneration (a degenerative eye disease that can cause blindness). One man was rendered a quadriplegic following a stem cell intervention for stroke. And a woman whose family sought treatment for her dementia died in Australia.

Other notorious cases involving the deaths of patients include the German government shutting down the X-Cell Centre and the Italian government closing the Stamina Foundation it had previously supported.

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REUTERS/Juan Carlos UlateAt present, the only recognised stem cell treatments are those utilising blood stem cells isolated from bone marrow, peripheral blood (the cellular components of blood such as red and white blood cells and platelets) or umbilical cord blood.

Hundreds of thousand of lives have been saved over the last half-century in patients with cancers such as leukaemia, lymphoma and multiple myeloma, as well as rare inherited immune and metabolic disorders.

A few types of cancer and autoimmune diseases may also benefit from blood stem cells in the context of chemotherapy. Different stem cells are also successfully used for corneal and skin grafting.

All other applications remain in the preclinical research phase or are just starting to be evaluated in clinical trials.

Often dismissed by for-profit clinics as red tape hampering progress, the rigour of clinical trials allows for the collection of impartial evidence. Such information is usually required before a new drug or medical device is released into the marketplace. Unfortunately, in the case of for-profit stem cell clinics, their marketing has gazumped the scientific evidence.

Action is required on many fronts. Regulators at both an international and national level need to tackle regulatory loopholes and challenge unfounded marketing claims of businesses selling unproven stem cell interventions.

Researchers need to more clearly communicate their findings and the necessary next steps to responsibly take their science from the laboratory to the clinic. And they should acknowledge that this will take time.

Patients and their loved ones must be encouraged to seek advice from a trained reputable health care professional, someone who knows their medical history. They should think twice if someone is offering a treatment outside standards of practice.

The stakes are too high not to have these difficult conversations. If a stem cell treatment sounds too good to be true, it probably is.

NOW WATCH: America's B-2 stealth bomber is unlike any military aircraft in the world

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WVU researchers study leukemia, bone marrow treatments – The Dominion Post

By NEVAGiles23

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WVU researchers study leukemia, bone marrow treatments - The Dominion Post

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BioTech Holdings Announces First Clinical Use of Microbiome Optimized Autologous Stem Cells – PR Newswire (press release)

By Sykes24Tracey

SAN DIEGO, July 7, 2017 /PRNewswire/ -- BioTech Holdings announced today clinical safety data on 3 patients suffering from critical limb ischemia treated with the Company's Procell microbiome-optimized personalized stem cell product.

In the investigator initiated pilot study, patients with diabetes associated circulation deficit in the legs (critical limb ischemia), who failed previous treatments were administered their own bone marrow derived stem cells that were treated with the Company's proprietary microbiome-derived compounds.

No treatment associated adverse reactions were observed and patients were followed-up for 3 months. Furthermore, 2 of the 3 patients had documented improvement in leg circulation and healing of previously unhealing ulcers.

"It is well known that the microbiome controls many aspects of human health and disease ranging from obesity, to autoimmunity, to even neurological function," said Thomas E Ichim, Ph.D, President and CEO of Biotech Holdings. "We are fortunate to have filed intellectual property on application of probiotics and microbiome manipulation to stem cells more than a year ago1. The current study supports our forward movement of our ProCell product to formal clinical trials."

The Company's product, Procell, comprises of bone marrow stem cells from the same patient, that are treated with factors generated by the microbiome of healthy patients. The key ingredient that the company has identified as secreted by the microbiome which augments stem cell activity is already approved by the FDA for other indications. Accordingly, the company believes it is eligible for accelerated FDA registration pathways, including the 505b2 pathway.

The Company intends to develop the indication of critical limb ischemia as its first condition. Patients with this conditions have a major amputation rate as high as 40% at 6 months and a mortality rate of 20% to 25% in the first year after presentation. Critical limb ischemia represents a market of approximately 10 billion dollar per year2.

Contacts

Thomas E Ichim, Ph.D President and Chief Executive Officer BioTech Holdings 9255 Towne Centre Drive, #450 San Diego, CA 92121 167146@email4pr.com 858 353 4303 Twitter: @biotechholdings

1http://www.prnewswire.com/news-releases/biotech-holdings-announces-positive-preclinical-results-on-procell-probiotic-cell-therapy-for-critical-limb-ischemia-300278136.html

2http://www.pluristem.com/wp-content/uploads/2016/04/Pluristem-January-2017.pdf

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/biotech-holdings-announces-first-clinical-use-of-microbiome-optimized-autologous-stem-cells-300484814.html

SOURCE Biotech Holdings

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BioTech Holdings Announces First Clinical Use of Microbiome Optimized Autologous Stem Cells - PR Newswire (press release)

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Private clinics’ unproven stem cell treatment is unsafe and unethical – Business Standard

By LizaAVILA

Professional medical organisations have raised concerns about these expensive cell therapies

Stem cell science is an area of medical research that continues to offer great promise. But as this weeks paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, are exploiting regulatory gaps to sell so-called stem cell treatments without evidence that what they offer is effective or even safe.

Such unregulated direct-to-consumer advertising typically of cells obtained using liposuction-like methods not only places the health of individuals at risk but could also undermine the legitimate development of stem cell-based therapies.

Many academic societies and professional medical organisations have raised concerns about these futile and often expensive cell therapies. Despite this, national regulators have typically been slow or ineffective in curtailing them.

As well as tighter regulations here, international regulators such as the World Health Organisation and the International Council on Harmonisation need to move on ensuring patients desperate for cures arent sold treatments with limited efficacy and unknown safety.

So whats on offer?

Hundreds of stem cell clinics post online claims that they have been able to treat patients suffering from a wide range of conditions. These include osteoarthritis, pain, spinal cord injury, multiple sclerosis, diabetes and infertility. The websites are high on the rhetoric of science often using various accreditation, awards and other tokens to imply legitimacy but low on proof that they work.

Rather than producing independently verified results, these clinics rely on patient testimonials or unsubstantiated claims of improvement. In so doing these shonky clinics understate the risks to patient health associated with these unproven stem cell-based interventions.

Properly administered informed consent is often overlooked or ignored, so patients can be misled about the likelihood of success. In addition to heavy financial burdens imposed on patients and their families, there is often an opportunity cost because the time wasted in receiving futile stem cells diverts patients away from proven medicines.

The many recent reports of adverse outcomes demonstrate the risks of receiving unproven cell therapies are not trivial. In the USA three women were blinded following experimental stem cell treatment for macular degeneration (a degenerative eye disease that can cause blindness). One man was rendered a quadriplegic following a stem cell intervention for stroke. And a woman whose family sought treatment for her dementia died in Australia.

Other notorious cases involving the deaths of patients include the German government shutting down the X-Cell Centre and the Italian government closing the Stamina Foundation it had previously supported.

Whats approved?

At present, the only recognised stem cell treatments are those utilising blood stem cells isolated from bone marrow, peripheral blood (the cellular components of blood such as red and white blood cells and platelets) or umbilical cord blood.

Hundreds of thousand of lives have been saved over the last half-century in patients with cancers such as leukaemia, lymphoma and multiple myeloma, as well as rare inherited immune and metabolic disorders.

A few types of cancer and autoimmune diseases may also benefit from blood stem cells in the context of chemotherapy. Different stem cells are also successfully used for corneal and skin grafting.

All other applications remain in the preclinical research phase or are just starting to be evaluated in clinical trials.

Often dismissed by for-profit clinics as red tape hampering progress, the rigour of clinical trials allows for the collection of impartial evidence. Such information is usually required before a new drug or medical device is released into the marketplace. Unfortunately, in the case of for-profit stem cell clinics, their marketing has gazumped the scientific evidence.

The action is required on many fronts. Regulators at both an international and national level need to tackle regulatory loopholes and challenge unfounded marketing claims of businesses selling unproven stem cell interventions.

Researchers need to more clearly communicate their findings and the necessary next steps to responsibly take their science from the laboratory to the clinic. And they should acknowledge that this will take time.

Patients and their loved ones must be encouraged to seek advice from a trained reputable health care professional, someone who knows their medical history. They should think twice if someone is offering a treatment outside standards of practice.

The stakes are too high not to have these difficult conversations. If a stem cell treatment sounds too good to be true, it probably is.

For more information on recognised stem cell treatments visit the National Stem Cell Foundation of Australia and Stem Cells Australia, Choice Australia, EuroStemCell, International Society for Stem Cell Research, and International Society for Cellular Therapy.

Megan Munsie, Deputy Director - Centre for Stem Cell Systems and Head of Education, Ethics, Law & Community Awareness Unit, Stem Cells Australia, University of Melbourne and John Rasko, Clinical Haematologist and President-Elect, International Society for Cellular Therapy., University of Sydney

This article was originally published on The Conversation. Read the original article.

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Private clinics' unproven stem cell treatment is unsafe and unethical - Business Standard

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Avera Medical Minute AMcK: Firefighter with recurrent Hodgkin Lymphoma will need bone marrow transplant in future … – KSFY

By raymumme

Firefighter Dustin Luebke puts his life on the line everyday protecting and serving the community. Never did he think his life would be threatened in a different way.

So now in 2017, Im going through it for the third time. So now its again recurring Hodgkins, said Luebke.

It all started in March of 2014. After 12 rounds of chemotherapy and six months in remission, it came back. He needed a stem cell transplant and was able to use his own stem cells.

Shortly after completing a year of chemotherapy after the transplant, it came back for the third time.

Its tough to swallow the first time and the second time. And then with the third time, its frustrating, said Luebke.

This father to three little girls will eventually need a bone marrow transplant.

But with this time, right now Im just doing an immunotherapy and were hoping that brings it back down to a cellular level and I can be on that for as long as until it stops working. So then it would require a stem cell transplant with a donor this time, said Luebke.

Thats where you and I can do our part and become part of the bone marrow registry and potentially be the match and save a life like Luebke's.

You fill out a short questionnaire. It talks about your health history and some personal questions, like how willing would you be to become a donor and then the swabbing process is really simple. We just swab each of your cheeks for a couple of minutes and then youre done, said Jalisa Spittler, transplant coordinator.

Spittler says 70% of patients who need a donor dont have a match in their family making the bone marrow registry their only hope.

We do have a lot of patients here that are waiting for matches that we just cant find for them. So its really helpful if we can create a diverse list with tons of people from here in South Dakota, said Spittler.

I got three little girls to raise and beautiful wife at home so I gotta stick around for a few more years, said Luebke.

Its pretty tough to realize that now youre relying on someone else where before it was all the medicine and just chemotherapy and now youre relying on somebody else with healthy stem cells to keep you going, said Luebke.

Sometimes it takes months to find a match.

Its taxing on them because they have to take more chemotherapy the longer it takes us to find a match for them. And the more chemotherapy they take, the harder it is on their body to get through the transplant. So its really important that we have a huge number of people to look at first, said Spittler.

Theres many ways that you can help out with people lives. And whether its in a fire, on a medical call and even helping somebody with life itself and furthering their life and making it better so they dont have to do chemotherapy anymore, said Luebke.

Luebke is a hero to this family and the community.

The first step to being someones cure is to join Be the Match Registry.

This Tuesday at the Oyate Community Center in Sioux Falls, there will be a bone marrow registry drive from noon to 7PM. It is put on by Avera, the city of Sioux Falls, and Be the Match. Registering takes less than 15 minutes.

For more information, just call 877-AT-AVERA.

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Avera Medical Minute AMcK: Firefighter with recurrent Hodgkin Lymphoma will need bone marrow transplant in future ... - KSFY

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