Antonio Regalado for MIT Technology Review 2014-10-15 19:15:44 UTC

When stem cells were first culled from human embryos sixteen years ago, scientists imagined they would soon be treating diabetes, heart disease, stroke, and many other diseases with cells manufactured in the lab.

It's all taken longer than they thought. But now, a Massachusetts biotech firm has reported results from the largest, and longest, human test of a treatment based on embryonic stem cells, saying it appears safe and may have partly restored vision to patients going blind from degenerative diseases.

Results of three-year study were described Tuesday in the Lancet by Advanced Cell Technology and collaborating eye specialists at the Jules Stein Eye Institute in Los Angeles who transplanted lab-grown cells into the eyes of nine people with macular degeneration and nine with Stargardt's macular dystrophy.

The idea behind Advanced Cell's treatment is to replace retinal pigment epithelium cells, known as RPE cells, a type of caretaker tissue without which a person's photoreceptors also die, with supplies grown in laboratory. It uses embryonic stem cells as a starting point, coaxing them to generate millions of specialized retina cells. In the study, each patient received a transplant of between 50,000 and 150,000 of those cells into one eye.

The main objective of the study was to prove the cells were safe. Beyond seeing no worrisome side effects, the researchers also noted some improvements in the patients. According to the researchers half of them improved enough to read two to three extra lines on an eye exam chart, results Robert Lanza, chief scientific officer of Advanced Cell, called remarkable.

"We have people saying things no one would make up, like 'Oh I can see the pattern on my furniture, or now I drive to the airport," he says. "Clearly there is something going on here."

Lanza stressed the need for a larger study, which he said the company hoped to launch later this year in Stargardt's patients. But if the vision results seen so far continue, Lanza says "this would be a therapy."

Some eye specialists said it's too soon to say whether the vision improvements were real. The patients weren't examined by independent specialists, they said, and eyesight in patients with low vision is notoriously difficult to measure. That leaves plenty of room for placebo effects or unconscious bias on the part of doctors.

"When someone gets a treatment, they try really hard to read the eye chart," says Stephen Tsang, a doctor at Columbia University who sees patients losing their vision to both diseases. It's common for patients to show quick improvements, he says, although typically not as large as what Advanced Cell is reporting.

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Stem Cell Eye Treatment May Restore Vision

Dr. Deepak Srivastava, a leading biomedical research policy expert, will discuss "Stem Cells, Regenerative Medicine and Policy Impediments to the New Future" at Rice University's Baker Institute for Public Policy Oct. 21. The event is free and open to the public, but registration is required.

Who: Dr. Deepak Srivastava, the Baker Institute's nonresident scholar for biomedical research policy and the Younger Family Director and senior investigator at the Gladstone Institute of Cardiovascular Disease.

Neal Lane, the Malcolm Gillis University Professor, senior fellow in science and technology policy at Rice's Baker Institute for Public Policy and a professor of physics and astronomy, will give introductory remarks.

Stem cells and regenerative medicine are exciting and emerging fields of biomedical research, according to event organizers. Proposed applications include treating conditions such as blindness, diabetes and heart disease. Regenerative medicine could also help heal failing organ systems and replace damaged tissue. While these fields hold great promise for medicine, external factors limit and, in some cases, stall research, organizers said. Ethical controversies surrounding human embryonic stem cells, policy issues affecting federal and state funding and regulation, and economic pressures all play a role in determining the future of research.

In his presentation, Srivastava will explore the current and future potential of stem cells and regenerative medicine. Following the presentation, he will discuss policy challenges and opportunities with Lane.

The event is sponsored by the Baker Institute's Science and Technology Policy Program and the Health Policy Forum.

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Stem cell, regenerative medicine policies to be discussed at Rice's Baker Institute

Knee arthritis 2.5 years after stem cell therapy by Harry Adelson, N.D.
Janet discusses her outcome three and a half years after bone marrow stem cell therapy by Dr Harry Adelson for her arthritic knees http://www.docereclinics.com.

By: Harry Adelson, N.D.

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Knee arthritis 2.5 years after stem cell therapy by Harry Adelson, N.D. - Video

Posted: Tuesday, October 14, 2014, 7:00 PM

TUESDAY, Oct. 14, 2014 (HealthDay News) -- A new study is the first to show the long-term safety of embryonic stem cell transplants to treat human disease.

The research involved 18 people who received the transplants to treat forms of macular degeneration, a leading cause of vision loss.

The transplants, which restored some sight in more than half of the patients, appeared safe up to three years after the procedure.

The study, funded by a U.S.-based company called Advanced Cell Technology, was published Oct. 14 in The Lancet.

"Embryonic stem cells have the potential to become any cell type in the body, but transplantation has been complicated by problems," lead author Dr. Robert Lanza, chief scientific officer at Advanced Cell Technology, said in a journal news release. Those problems include the rejection of the transplanted cells by the patient's immune system, as well as the danger that the cells might spur certain types of cancers called teratomas.

A teratoma is a type of cancer that occurs when stem cells develop into multiple types of cells and form incompatible tissues that can include teeth and hair.

As Lanza explained, because of these issues, scientists interested in embryonic stem cell therapy have tended to focused on sites in the body that typically do not produce a strong immune response. The eye is one such spot.

In the new study, human embryonic stem cells were first prompted to develop into eye cells called retinal pigment epithelial cells. They were then transplanted into nine people with Stargardt's macular dystrophy, and another nine with dry atrophic age-related macular degeneration.

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Embryonic Stem Cell Therapy Shows Long-Term Effectiveness, Safety

TIME Health medicine Stem Cells Allow Nearly Blind Patients to See Stem cells could lead to new treatments for eye disorders Photography by Peter A. KemmerGetty Images/Flickr RF Embryonic stem cells can be turned into a therapy to help the sight of the nearly blind

In a report published in the journal Lancet, scientists led by Dr. Robert Lanza, chief scientific officer at Advanced Cell Technology, provide the first evidence that stem cells from human embryos can be a safe and effective source of therapies for two types of eye diseasesage-related macular degeneration, the most common cause of vision loss in people over age 60, and Stargardts macular dystrophy, a rarer, inherited condition that can leave patients legally blind and only able to sense hand motions.

In the study, 18 patients with either disorder received transplants of retinal epithelial cells (RPE) made from stem cells that came from human embryos. The embryos were from IVF procedures and donated for research. Lanza and his team devised a process of treating the stem cells so they could turn into the RPE cells. In patients with macular degeneration, these are the cells responsible for their vision loss; normally they help to keep the nerve cells that sense light in the retina healthy and functioning properly, but in those with macular degeneration or Stargardts, they start to deteriorate. Without RPE cells, the nerves then start to die, leading to gradual vision loss.

MORE: Stem Cell Miracle? New Therapies May Cure Chronic Conditions Like Alzheimers

The transplants of RPE cells were injected directly into the space in front of the retina of each patients most damaged eye. The new RPE cells cant force the formation of new nerve cells, but they can help the ones that are still there to keep functioning and doing their job to process light and help the patient to see. Only one RPE can maintain the health of a thousand photoreceptors, says Lanza.

The trial is the only one approved by the Food and Drug Administration involving human embryonic stem cells as a treatment. (Another, the first to gain the agencys approval, involved using human embryonic stem cells to treat spinal cord injury, but was stopped by the company.) Because the stem cells come from unrelated donors, and because they can grow into any of the bodys many cells types, experts have been concerned about their risks, including the possibility of tumors and immune rejection.

MORE: Early Success in a Human Embryonic Stem Cell Trial to Treat Blindness

But Lanza says the retinal space in the eye is the ideal place to test such cells, since the bodys immune cells dont enter this space. Even so, just to be safe, the patients were all given drugs to suppress their immune system for one week before the transplant and for 12 weeks following the surgery.

While the trial was only supposed to evaluate the safety of the therapy, it also provided valuable information about the technologys potential effectiveness. The patients have been followed for more than three years, and half of the 18 were able to read three more lines on the eye chart. That translated to critical improvements in their daily lives as wellsome were able to read their watch and use computers again.

Our goal was to prevent further progression of the disease, not reverse it and see visual improvement, says Lanza. But seeing the improvement in vision was frosting on the cake.

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Stem Cells Allow Nearly Blind Patients to See

A treatment based on embryonic stem cells clears a key safety hurdle, and might help restore vision.

When stem cells were first culled from human embryos sixteen years ago, scientists imagined they would soon be treating diabetes, heart disease, stroke, and many other diseases with cells manufactured in the lab.

Its all taken longer than they thought. But today, a Massachusetts biotech firm reported results from the largest, and longest, human test of a treatment based on embryonic stem cells, saying it appears safe and may have partly restored vision to patients going blind from degenerative diseases.

Results of three-year study were described today in the Lancet by Advanced Cell Technology and collaborating eye specialists at the Jules Stein Eye Institute in Los Angeles who transplanted lab-grown cells into the eyes of nine people with macular degeneration and nine with Stargardts macular dystrophy.

The idea behind Advanced Cells treatment is to replace retinal pigment epithelium cells, known as RPE cells, a type of caretaker tissue without which a persons photoreceptors also die, with supplies grown in laboratory. It uses embryonic stem cells as a starting point, coaxing them to generate millions of specialized retina cells. In the study, each patient received a transplant of between 50,000 and 150,000 of those cells into one eye.

The main objective of the study was to prove the cells were safe. Beyond seeing no worrisome side effects, the researchers also noted some improvements in the patients. According to the researchers half of them improved enough to read two to three extra lines on an eye exam chart, results Robert Lanza, chief scientific officer of Advanced Cell, called remarkable.

We have people saying things no one would make up, like Oh I can see the pattern on my furniture, or now I drive to the airport, he says. Clearly there is something going on here.

Lanza stressed the need for a larger study, which he said the company hoped to launch later this year in Stargardts patients. But if the vision results seen so far continue, Lanza says this would be a therapy.

Some eye specialists said its too soon to say whether the vision improvements were real. The patients werent examined by independent specialists, they said, and eyesight in patients with low vision is notoriously difficult to measure. That leaves plenty of room for placebo effects or unconscious bias on the part of doctors.

When someone gets a treatment, they try really hard to read the eye chart, says Stephen Tsang, a doctor at Columbia University who sees patients losing their vision to both diseases. Its common for patients to show quick improvements, he says, although typically not as large as what Advanced Cell is reporting.

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Stem Cells Seem Safe in Treating Eye Disease

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14-Oct-2014

Contact: Greg Williams newsmedia@mssm.edu 212-241-9200 The Mount Sinai Hospital / Mount Sinai School of Medicine @mountsinainyc

A Mount Sinai-led research team has discovered a new kind of stem cell that can become either a liver cell or a cell that lines liver blood vessels, according to a study published today in the journal Stem Cell Reports. The existence of such a cell type contradicts current theory on how organs arise from cell layers in the embryo, and may hold clues to origins of, and future treatment for, liver cancer.

Thanks to stem cells, humans develop from a single cell into a complex being made up of more than 200 cell types. The original, single human stem cell, the fertilized embryo, has the potential to develop into every kind of human cell. Stem cells multiply (proliferate) and specialize (differentiate) until millions of functional cells result, including liver cells (hepatocytes), blood vessel cells (endothelial cells), muscle cells, bone cells, etc.

In the womb, the human embryo early on becomes three "germ" layers of stem cells the endoderm, mesoderm and ectoderm. The long-held consensus was that the endoderm goes on to form the liver and other gut organs; the mesoderm the heart, muscles and blood cells; and the ectoderm the brain and skin. Researchers have sought to determine the germ layer that yields each organ because these origins hold clues to healthy function and disease mechanisms in adults.

"We found a stem cell that can become either a liver cell, which is thought to originate in the endoderm, or an endothelial cell that helps to from a blood vessel, which was thought to derive from the mesoderm," said Valerie Gouon-Evans, PhD, Assistant Professor in the Department of Developmental and Regenerative Biology and Black Family Stem Cell Institute, Icahn School of Medicine at Mount Sinai, and lead author for the study. "Our results go against traditional germ layer theory, which holds that a stem cell can only go on to become cell types in line with the germ layer that stem cell came from. Endothelial cells may arise from both the endoderm and mesoderm."

Cell Growth Plusses and Minuses

Beyond the womb, many human organs contain pools of partially differentiated stem cells, which are ready to differentiate into specific replacement cells as needed. Among these are stem cells that "know" they are liver cells, but have enough "stemness" to become more than one cell type.

By advancing the understanding of stem cell processes in the liver, the study offers insights into mechanisms that drive liver cancer. The rapid growth seen in cells as the fetal liver develops is similar in some ways to the growth seen in tumors. Among the factors that make both possible is the building of blood vessels that supply nutrients and oxygen.

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Stem cell discovery challenges dogma on how fetus develops; holds insights for liver cancer and reg

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14-Oct-2014

Contact: David McKeon DMcKeon@nyscf.org 212-365-7440 New York Stem Cell Foundation @nyscf

NEW YORK, NY (October 14, 2014) The New York Stem Cell Foundation (NYSCF) announced today that Marius Wernig, PhD, Associate Professor in the Institute for Stem Cell Biology and Regenerative Medicine and the Department of Pathology at Stanford University School of Medicine, is the 2014 recipient of the NYSCF Robertson Stem Cell Prize, which has been awarded since 2011 for extraordinary achievements in translational stem cell research by a young scientist.

Dr. Wernig and his team discovered that human skin cells can be converted directly into functional neurons, termed induced neuronal (iN) cells, in a period of four to five weeks with the addition of just four proteins.

"Dr. Wernig's groundbreaking research has the potential to accelerate all research on devastating neurodegenerative diseases," said Susan L. Solomon, CEO and Co-founder of NYSCF. "His work can impact and accelerate research on multiple sclerosis, Alzheimer's disease, and autism among many other conditions."

At Stanford, Dr. Wernig focuses on using induced pluripotent stem (iPS) cells and iN cells for disease modeling and as potential cellular therapy. This new technique transformed the field of cellular reprogramming by eliminating the need to first create iPS cells, making it easier to generate patient or disease-specific neurons. These cell types hold tremendous therapeutic and translational relevance for patients around the world. Potential applications range from replacing damaged brain tissue to repairing the myelinating nerves lost in multiple sclerosis to identifying novel drugs and treatments for a range of neurological diseases.

In addition to his recent scientific achievements, Dr. Wernig was part of the inaugural class of NYSCF Robertson Stem Cell Investigators in 2010, and is the first NYSCF Robertson Investigator to receive the NYSCF Robertson Stem Cell Prize.

"I am delighted that Dr. Wernig is being recognized with this year's NYSCF Robertson Prize for his important research that has opened entirely new avenues for studying brain diseases. The NYSCF Robertson Prize was created to acknowledge the most important work being down by young stem cell scientists and I am thrilled to see a NYSCF Robertson Investigator go on to receive NYSCF Robertson Prize," said Julian Robertson, whose foundation underwrites the $200,000 prize. The terms of the prize require that the $200,000 stipend be used, at the recipients' discretion, to further support their research.

The NYSCF Robertson Stem Cell Prize will be presented to Dr. Wernig at a ceremony in New York City by Susan L. Solomon on October 14th.

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Marius Wernig receives New York Stem Cell Foundation's Robertson Stem Cell Prize

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13-Oct-2014

Contact: Robert Miranda cogcomm@aol.com Cell Transplantation Center of Excellence for Aging and Brain Repair

Putnam Valley, NY. (Oct. 13, 2014) Two studies recently published in Cell Transplantation reveal that cell transplantation may be an effective treatment for spinal cord injury (SCI), a major cause of disability and paralysis with no current restorative therapies.

Using laboratory rats modeled with SCI, researchers in Spain found in laboratory tests on cells harvested from rats - specifically ependymal progenitor cells (epSPCs), multipotent stem cells found in adult tissues surrounding the ependymal canal of the spinal cord - responded to a variety of compounds through the activation of purinergic receptors P2X4, P2X7, P2Y1 and P2Y4. In addition, the epSPCs responded to adenosine triphosphate (ATP) through this activation. ATP, a chemical produced by a wide variety of enzymes that works to transport energy within cells, is known to accumulate at the sites of spinal cord injury and cooperate with growth factors that induce remodeling and repair.

"The aim of our study was to analyze the expression profile of receptors in ependymal-derived neurospheres and to determine which receptors were functional by analysis of intercellular Ca2+ concentration," said study co-author Dr. Rosa Gomez-Villafuertes of the Department of Biochemistry at the Veterinary School at the University of Complutense in Madrid, Spain. "We demonstrated for the first time that epSPCs express functional ionotropic P2X4 and P2X7 and metabotropic P2Y1 and P2Y4 receptors that are able to respond to ATP, ADP and other nucleotide compounds."

When they compared the epSPCs from healthy rats to epSPCs from rats modeled with SCI, they found that a downregulation of P2Y1 and an upregulation of P2Y4 had occurred in the epSPCs in the SCI group.

"This finding opens an important avenue for potential therapeutic alternatives in SCI treatments based on purinergic receptor modulation," the researchers concluded.

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The study will be published in a future issue of Cell Transplantation and is currently freely available on-line as an unedited early e-pub at: http://www.ingentaconnect.com/content/cog/ct/pre-prints/content-CT-1257_Gomez_Villafuertes.

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Spinal cord injury victims may benefit from stem cell transplantation studies

Oct 13, 2014 Stem cells show auxeticity; the nucleus expands, rather than thins, when it's stretched. Credit: Effigos AG

Looking at stem cells through physicists' eyes is challenging some of our basic assumptions about the body's master cells.

One of the many mysteries surrounding stem cells is how the constantly regenerating cells in adults, such as those in skin, are able to achieve the delicate balance between self-renewal and differentiation in other words, both maintaining their numbers and producing cells that are more specialised to replace those that are used up or damaged.

"What all of us want to understand is how stem cells decide to make and maintain a body plan," said Dr Kevin Chalut, a Cambridge physicist who moved his lab to the University's Wellcome Trust-MRC Cambridge Stem Cell Institute two years ago. "How do they decide whether they're going to differentiate or stay a stem cell in order to replenish tissue? We have discovered a lot about stem cells, but at this point nobody can tell you exactly how they maintain that balance."

To unravel this mystery, both Chalut and another physicist, Professor Ben Simons, are bringing a fresh perspective to the biologists' work. Looking at problems through the lens of a physicist helps them untangle many of the complex datasets associated with stem cell research. It also, they say, makes them unafraid to ask questions that some biologists might consider 'heretical', such as whether a few simple rules describe stem cells. "As physicists, we're very used to the idea that complex systems have emergent behaviour that may be described by simple rules," explained Simons.

What they have discovered is challenging some of the basic assumptions we have about stem cells.

One of those assumptions is that once a stem cell has been 'fated' for differentiation, there's no going back. "In fact, it appears that stem cells are much more adaptable than previously thought," said Simons.

By using fluorescent markers and live imaging to track a stem cell's progression, Simons' group has found that they can move backwards and forwards between states biased towards renewal and differentiation, depending on their physical position in the their host environment, known as the stem cell niche.

For example, some have argued that mammals, from elephants to mice, require just a few hundred blood stem cells to maintain sufficient levels of blood in the body. "Which sounds crazy," said Simons. "But if the self-renewal potential of cells may vary reversibly, the number of cells that retain stem cell potential may be much higher. Just because a certain cell may have a low chance of self-renewal today doesn't mean that it will still be low tomorrow or next week!"

Chalut's group is also looking at the way in which stem cells interact with their environment, specifically at the role that their physical and mechanical properties might play in how they make their fate decisions. It's a little-studied area, but one that could play a key role in understanding how stem cells work.

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Stem cell physical

Suzanne Kreiter/Boston Globe/Getty

A research team led by Douglas Melton (left) has made insulin-secreting cells using human stem cells.

Each year, surgeon Jose Oberholzer frees a few people with type1 diabetes from daily insulin injections by giving them a transplant of the insulin-secreting -cells that the disease attacks. But it is a frustrating process. Harvested from a cadavers pancreas, the -cells are in short supply and vary in quality. And the patients must take drugs to suppress their immune response to the foreign cells, which can in turn cause kidney failure.

On 9October, stem-cell researcher Douglas Melton of Harvard University in Cambridge, Massachusetts, and his colleagues reported an advance that has the potential to overcome Oberholzers frustrations and allow many more people with type1 diabetes to receive transplants. Melton and his team have achieved a long-term goal of stem-cell science: they have created mature -cells using human stem cells that can be grown from a potentially unlimited supply, and that behave like the real thing (F.W.Pagliuca etal. Cell 159, 428439; 2014). The next challenge is to work out how to shield these -cells from the bodys immune response.

Researchers had previously created immature -cells from stem cells and transplanted them into diabetic mice. But they take months to mature into insulin-secreting cells, and it is unclear whether they would do so in humans.

The -cells reported by Meltons team were grown from adult cells that had been reprogrammed to resemble stem cells. In response to glucose, the -cells quickly secreted insulin, which the body uses to regulate blood sugar. When implanted in diabetic mice, the cells relieved symptoms within two weeks. The -cells even formed clusters that are similar to those found in a pancreatic structure called the islet of Langerhans. If you took these cells and showed them to somebody without telling them what they are, I guarantee you an expert would say that is a perfect human islet cell, says Oberholzer, who is working with Meltons team to test the cells in non-human primates.

A remaining hurdle is shielding the cells from immune attack. This is necessary if the treatment is to become more widely available, because immunosuppressant drugs can be justified only in the most severe cases of diabetes. And although mature -cells could be derived from a patients own skin cells, type1 diabetes is an autoimmune disease, so transplanted cells would still be vulnerable to attack.

One solution might be to encapsulate the cells in a credit-card-sized, biocompatible sheath made by ViaCyte of San Diego, California. The company will implant its first device loaded with immature -cells in a patient on 21October. Studies in animals have been promising, but some researchers worry that the cells inside the device are packed too densely and might become starved of oxygen and nutrients.

Another option is to coat cells in a protective hydrogel, which results in thousands of separate balls of cells. But a potential drawback is that it would be much harder to remove such cells if there was a safety concern, says Albert Hwa, director of discovery science at JDRF, a diabetes-research foundation in New York.

Neither technique avoids the bodys tendency to enclose foreign bodies inside scar tissue, which could cut the transplanted cells off from nutrients. Bioengineer Daniel Anderson of the Massachusetts Institute of Technology in Cambridge and his team are screening chemical compounds for a hydrogel that does not trigger this. Some, used with Meltons cells, have shown promise in unpublished studies of diabetic primates, he says.

Read more:
Stem-cell success poses immunity challenge for diabetes

Researchers have developed a technique to jump-start the body's systems for creating blood vessels, opening the door for potential new treatments for diseases whose impacts include amputation and blindness.

The international team, led by scientists at the Indiana University School of Medicine, is targeting new therapies for illnesses such as peripheral artery disease, a painful leg condition caused by poor blood circulation. The disease can lead to skin problems, gangrene and sometimes amputation.

While the body has cells that specialize in repairing blood vessels and creating new ones, called endothelial colony-forming cells, these cells can lose their ability to proliferate into new blood vessels as patients age or develop diseases like peripheral arterial disease, said Mervin C. Yoder Jr., M.D., Richard and Pauline Klingler Professor of Pediatrics at IU and leader of the research team.

Peripheral artery disease patients can be given medication to improve blood flow, but if the blood vessels to carry that improved flow are reduced in number or function, the benefits are minimal. If "younger," more "enthusiastic" endothelial colony forming cells could be injected into the affected tissues, they might jump-start the process of creating new blood vessels. Gathering those cells would not be easy however -- they are relatively difficult to find in adults, especially in those with peripheral arterial disease. However, they are present in large numbers in umbilical cord blood.

Reporting their work in the journal Nature Biotechnology, the researchers said they had developed a potential therapy through the use of patient-specific induced pluripotent stem cells, which are normal adult cells that have been "coaxed" via laboratory techniques into reverting into the more primitive stem cells that can produce most types of bodily tissue. So, in one of the significant discoveries reported in the Nature Biotechnology paper, the research team developed a novel methodology to mature the induced pluripotent stem cells into cells with the characteristics of the endothelial colony-forming cells that are found in umbilical cord blood. Those laboratory-created endothelial colony-forming cells were injected into mice, where they were able to proliferate into human blood vessels and restore blood flow to damaged tissues in mouse retinas and limbs.

Overcoming another hurdle that has been faced by scientists in the field, the research team found that the cord-blood-like endothelial colony-forming cells grown in laboratory tissue culture expanded dramatically, creating 100 million new cells for each original cell in a little less than three months.

"This is one of the first studies using induced pluripotent stem cells that has been able to produce new cells in clinically relevant numbers -- enough to enable a clinical trial," Dr. Yoder said. The next steps, he said, include reaching an agreement with a facility approved to produce cells for use in human testing. In addition to peripheral artery disease, the researchers are evaluating the potential uses of the derived cells to treat diseases of the eye and lungs that involve blood flow problems.

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The above story is based on materials provided by Indiana University. Note: Materials may be edited for content and length.

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New cells meant to form blood vessels developed, treat peripheral artery disease

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Newswise INDIANAPOLIS -- Researchers have developed a technique to jump-start the body's systems for creating blood vessels, opening the door for potential new treatments for diseases whose impacts include amputation and blindness.

The international team, led by scientists at the Indiana University School of Medicine, is targeting new therapies for illnesses such as peripheral artery disease, a painful leg condition caused by poor blood circulation. The disease can lead to skin problems, gangrene and sometimes amputation.

While the body has cells that specialize in repairing blood vessels and creating new ones, called endothelial colony-forming cells, these cells can lose their ability to proliferate into new blood vessels as patients age or develop diseases like peripheral arterial disease, said Mervin C. Yoder Jr., M.D., Richard and Pauline Klingler Professor of Pediatrics at IU and leader of the research team.

Peripheral artery disease patients can be given medication to improve blood flow, but if the blood vessels to carry that improved flow are reduced in number or function, the benefits are minimal. If "younger," more "enthusiastic" endothelial colony forming cells could be injected into the affected tissues, they might jump-start the process of creating new blood vessels. Gathering those cells would not be easy however -- they are relatively difficult to find in adults, especially in those with peripheral arterial disease. However, they are present in large numbers in umbilical cord blood.

Reporting their work in the journal Nature Biotechnology, the researchers said they had developed a potential therapy through the use of patient-specific induced pluripotent stem cells, which are normal adult cells that have been "coaxed" via laboratory techniques into reverting into the more primitive stem cells that can produce most types of bodily tissue. So, in one of the significant discoveries reported in the Nature Biotechnology paper, the research team developed a novel methodology to mature the induced pluripotent stem cells into cells with the characteristics of the endothelial colony-forming cells that are found in umbilical cord blood. Those laboratory-created endothelial colony-forming cells were injected into mice, where they were able to proliferate into human blood vessels and restore blood flow to damaged tissues in mouse retinas and limbs.

Overcoming another hurdle that has been faced by scientists in the field, the research team found that the cord-blood-like endothelial colony-forming cells grown in laboratory tissue culture expanded dramatically, creating 100 million new cells for each original cell in a little less than three months.

"This is one of the first studies using induced pluripotent stem cells that has been able to produce new cells in clinically relevant numbers -- enough to enable a clinical trial," Dr. Yoder said. The next steps, he said, include reaching an agreement with a facility approved to produce cells for use in human testing. In addition to peripheral artery disease, the researchers are evaluating the potential uses of the derived cells to treat diseases of the eye and lungs that involve blood flow problems.

A short video explaining the research is available here: http://youtu.be/nyPk_5bLdzs

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Researchers Develop New Cells Meant to Form Blood Vessels, Treat Peripheral Artery Disease

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This announcement is available online at http://www.uphs.upenn.edu/news/News_Releases/2014/10/nih/

Newswise PHILADELPHIA Roberto Bonasio, PhD, an assistant professor of Cell and Developmental Biology, Perelman School of Medicine at the University of Pennsylvania, and a core member of the Penn Epigenetics Program is one of the recipients of a 2014 New Innovator Award from the National Institutes of Health (NIH).

The NIH Directors New Innovator Award, totaling $1.5 million over five years for each of the 50 recipients this year, supports highly innovative research and creative, new investigators who exhibit strong potential to make great advances on a critical biomedical or behavioral research problem. The initiative, established in 2007, supports investigators who are within 10 years of their terminal degree or clinical residency, who have not yet received a research project grant (R01), or equivalent NIH grant, to conduct unusually innovative research.

Bonasio studies the molecular mechanisms of epigenetic memory, which are key to a number of biological processes, including embryonic development, cancer, stem cell pluripotency, and brain function. In particular, he will be looking at gene expression controlled by epigenetic pathways that alter the chemical structure of chromosomes and allow for multiple cell identities to arise from a single genome. These pathways are also critical in the brain and their improper functioning can cause mental retardation, cognitive decline, and psychiatric disorders.

Bonasio has chosen ants as a model system. With colleagues Shelley Berger, PhD, who directs the Penn Epigenetics program; postdoctoral mentor Danny Reinberg, PhD, New York University; and Jrgen Liebig, PhD, Arizona State University, Bonasio has established the ant Harpegnathos saltator as a laboratory model to study epigenetics, the process by which a single genome gives rise to a variety of physiological outcomes.

This phenomenon is particularly evident in ants, as they live in caste-based societies in which most of the individuals are sterile females, limited to highly specialized roles such as workers and soldiers. Only one queen and the relatively small contingent of male ants are fertile and able to reproduce. Yet despite such extreme differences in behavior and physical form, all females within the colony appear to be genetically identical.

Also see the University of Pennsylvania release.

###

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Penn Medicine Researcher Receives New Innovator Award from National Institutes of Health

By C. Rajan, contributing writer

The U.S. FDA has just granted BrainStorm Cell Therapeutics novel stem cell therapy, NurOwn, Fast Track status for the treatment of amyotrophic lateral sclerosis (ALS), the company announced via press release.

"We are pleased that the FDA has granted Fast Track status for NurOwn as this will allow us greater and more frequent dialogue with the Agency as we continue the development of this ground-breaking cell therapy for the treatment of ALS," said Tony Fiorino, MD, PhD, CEO of BrainStorm. "We expect Fast Track designation, which recognizes the potential of NurOwn as to address an unmet medical need in ALS, to help speed and improve our development program."

Israeli biotech company BrainStorm is developing novel adult stem cell technologies for neurodegenerative diseases, such as ALS. The company licensed the exclusive rights to the NurOwn technology from Ramot, the technology transfer company of Tel Aviv University.

NurOwn is a personalized stem cell product made from autologous mesenchymal stem cells. These adult stem cells are obtained from the patients bone marrow and are induced to secrete neurotrophic factors, which are growth factors that can stimulate the survival and maintenance of neurons that degenerate in neurologic disorders.

NurOwn is currently being studied in randomized, double-blind, placebo-controlled phase 2 clinical trials in ALS patients in both Israel and the U.S. Reuters reports that the last patient visit has been completed in the phase 2a clinical trial in Jerusalem. The company expects to release final results of the study by the end of this year. The U.S. arm of the Phase 2 study is being conducted at three sites in the U.S., and is expected to be wrapped up in early 2015.

The FDA's Fast Track program aims to speed up the development of new drugs and biologics in order to get them to patients suffering from serious, unmet medical needs. The Fast Track designation will allow BrainStorm Cell to submit an NDA on a rolling basis and will grant the company more communication and support from FDA during the development process.

ALS, also known as Lou Gehrig's disease, is a rapidly progressive neurological disease that results in death within 2 to 5 years of diagnosis in most cases, and less than 20 percent of patients live more than 5 years after onset of symptoms. The relatively rare condition affects about 2 persons in every 100,000, with approximately 5,600 new cases diagnosed every year in the U.S, according to the ALS Association.

There is no cure for the disease to date, although the only approved ALS drug, Riluzole, has demonstrated its ability to extend survival by at least a few months.

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Stem Cell Therapy For ALS Gets FDA's Fast Track Designation

By Richard M. Cohen

image courtesy Richard Cohen

I am one of twenty struggling every day with multiple sclerosis to be included in an innovative, phase one stem cell clinical trial at the Tisch MS Research Center of New York. Now theres a mouthful. Please let me explain. Many of us read tidbits about cell therapy and think it simply is space-age medicine that will be launched in the future.

In fact, we are at the starting line now, and the race has begun. A phase one trial tests safety. The group is small, and all are treated with the real thing. No placebos, sugar pills. The trial tests autologous cells, which mean our own. That eliminates rejection and alters risk. No new medical procedure comes risk-free, but the dangers are minimal. The stem cells are pulled from bone marrow harvested from our breast bones. Sounds hideous. It is not.

In this trial, the stem cells are infused directly into the spinal column. Nope. Not painful at all. Then we watch and wait. Results, if there are to be any, can take many months to show themselves. This particular procedure has never been used before. I was the first in the group to be treated, making me the first in the world to have this done. For more than forty years, I have lived with an illness that left no room for hope. Suddenly, that has changed, though change does not necessarily come easily.

The expectation game is dangerous. No one really knows what to expect from this experiment. My doctor makes that point over and over. Yet it is hard to control the fantasies that inevitably pop into my head. The possibility of restoring at least some vision when I have been legally blind for years is enticing, to say the least. I used to run and race or simply hike up country hills. Now I hobble on a cane. I am lucky if I can stay on my feet walking two city blocks. The possibility of restored mobility takes my breath away.

I know better than to go too far down these roads in my mind, but that visual journey is unavoidable. Maybe that is okay. Hope is a funny thing. We need something to hope for. Any doctor will tell you attitude is an important factor in fighting a disease. I have learned the power of remaining positive. We need fuel to keep the engine running. Those flights of fancy, imagining we can be better than we are, to some extent can become self-fulfilling prophecies.

This is an exciting period in the history of medicine. That probably has been said throughout the ages. Science does not stand still. No one can see around the bend. That may be what makes hope possible, the idea that there is something just out of sight that is revolutionary and good, just waiting for us to get there.

Richard M. Cohen writes Journey Man, an independent blog, also carried by The Huffington Post. Cohen is the author of Blindsided, published in 2004, which chronicled his battles with multiple sclerosis and cancer, and Strong at the Broken Places in 2008, both New York Times Best Sellers. Cohens latest book, I Want to Kill the Dog, was published in 2012. Cohen is married to journalist, Meredith Vieira, with whom he has three grown children.

Excerpt from:
One MS patient's 'starting line' for stem cell therapy

After 26 years in a wheel chair William Orr is walking. Granted it is with the assistance of a walker, but he is walking. Orr is walking to get his mail, he is walking to rehab from his parked car and he is planning on walking into his 35th high school reunion. The 52-year-old Aurora man has been a quadriplegic for half his life, since a car hit him while he was riding his bike back in 1986. He suffered a C6-C7 incomplete spinal cord injury and has used a wheel chair since.In August of 2010, Orr underwent what many believe is a first of its kind stem cell procedure in Naples, Florida, using bone marrow from his hip that doctors believe has regenerated damaged cells in his spinal cord. He had such a good response that a second treatment was performed in July 2012. Subsequently, Orr has gained both motor and sensory improvement, as well as having the majority of his muscle spasms dissipate.

There is a remarkable difference. The results for Mr. Orr and others in the treatment group are truly remarkable and have exceeded our expectations said Michael Calcaterra for Intercellular Sciences. Frankly, this is an area that regeneration was thought not to be possible.

I feel like a new person, said Orr. And its only going to get better. He hopes to someday be walking without the walker. Doctors believe that if his quadriceps strength continues to improve as well as his foot lift, then its a real possibility. In the meantime, hes relishing every new sensation, big or small. Its this amazing work ethic and attitude along with the stem cells, his doctor insists, that will help get this man back on his feet again.

UPDATE:

In July 2013, Mr. Orr took his first independent steps in 27 years as his spinal regeneration continues.

About Adult Stem Cells

Stem cells reside in adult bone marrow and fat, as well as other tissues and organs of the body. These cells have a natural ability to repair damaged tissue, however in people with degenerative diseases they are not released and directed enough to fully repair damaged tissue. Adult stem cells can be extracted from many areas of the body, including the bone marrow, fat, and peripheral blood. Since the stem cells come from the patient there is no possibility for rejection or tumor formation, also there is none of the moral issues involving embryonic cells. Stem cells isolated from the bone marrow or fat have the ability to become different cell types (i.e. nerve cells, liver cells, heart cells, and cartilage cells). Studies have also shown that these cells are capable of homing to and repairing damaged tissue. Studies have shown that these stem cells secrete proteins and peptides that stimulate healing of damaged tissue, including heart muscle and spinal cord. Animal studies have shown stem cells to be reparative in spinal cord injury.

About the Procedure

Spinal cord injury patients are treated utilizing stem cells from their own bodies. The procedure involves obtaining 480ml of bone marrow aspirate from the hip bone, this is done under anesthesia so the patient is completely comfortable. The sample is then put through a process that first activates and then concentrates the stem cells. The stem cells are then delivered to the area of spinal injury utilizing a novel method of intra-arterial injection in a vascular angiography suite. This is an outpatient procedure and minimally invasive. The patient is discharged later that day.

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Spinal Cord Injuries | Quadriplegic | Stem Cells | Stem ...

Volume 9, Issue 1 Summary

A groundbreaking study on repairing damaged heart tissue through stem cell therapy has given patients hope that they may again live active lives. An international team of Mayo Clinic researchers and collaborators has done it by discovering a way to regenerate heart tissue.

Clinical trial participant Miroslav Dlacic near his home in Belgrade.

Andre Terzic, M.D., Ph.D., is the Michael S. and Mary Sue Shannon Family Director, Center for Regenerative Medicine, and the Marriott Family Professor of Cardiovascular Diseases Research at Mayo Clinic in Minnesota.

Miroslav Dlacic's heart attack changed his life drastically and seemingly forever. His damaged heart made him too tired to work in his garden or to spend much time at his leather-accessories workshop in Belgrade, Serbia. Like many patients with heart problems, Dlacic, who is 71, thought he would live his remaining years in a weakened condition.

Then, a groundbreaking Mayo Clinic trial of stem cell therapy to repair damaged heart tissue changed his life again this time for the better.

Dlacic agreed to participate in the Mayo Clinic stem cell trial through the hospital in Serbia where he is treated. Two years later, Dlacic is able to walk again without becoming worn out.

"I am more active, more peppy," he says. "I feel quite well."

"It's a paradigm shift," says Andre Terzic, M.D., Ph.D., director of Mayo Clinic's Center for Regenerative Medicine and senior investigator of the stem cell trial. "We are moving from traditional medicine, which addresses the symptoms of disease, to being legitimately able to cure disease."

For decades, treating patients with cardiac disease has typically involved managing heart damage with medication. It's a bit like driving a car without fixing a sluggish engine you manage the consequences as best you can and learn to live with them.

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Regenerating heart tissue through stem cell therapy ...

Updated: 10/12/2014 4:19 PM Created: 10/11/2014 11:51 PM WNYT.com By: Steve Flamisch

LOUDONVILLE Four years ago, Doris Calderon was diagnosed with a form of blood cancer called Myelodysplastic Syndrome (MDS). Doctors told her she needed a bone marrow transplant.

"They were looking for a donor because I had no siblings that could match, and my children are not a good match," said Calderon, of Halfmoon. "We didn't have anybody, so we just figured we'd wait."

More than 800 miles away, in Illinois, a total stranger made a fateful decision later that year. Chad LaMont wanted to donate blood to at his employers "Good Deed Day," but his iron was too low.

LaMont went over to the "Be The Match" table and signed up to be a marrow donor, instead. He turned out to be the match for Calderon, later donating the stem cells and T-cells that saved her life.

"Ive encouraged so many people to get on the list because you never know who you can save, and whose life you can change at the end of the day," LaMont said.

On Friday, Calderon and LaMont met for the first time at Albany International Airport. On Saturday, they took part in the Light the Night Walk at Siena College, raising money to fight blood cancer.

"To have the man responsible for saving my mother's life with us on such a momentous occasion is just such a blessing," said Calderons daughter, Lisa Calderon-Haun. "He couldn't be more wonderful."

Calderon has been in remission for more than two years and her prognosis is good. To learn more about how to become a bone marrow donor, visit "Be The Match."

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Saratoga Co. woman meets marrow donor who saved her life

MIAMI (PRWEB) October 13, 2014

Regenestem, one of the largest membership networks of regenerative medicine clinics worldwide, has announced the launch of a new stem cells clinic in Antofagasta, Northern Chile. The clinic, to be headed by renowned stem cell specialists DRA Maria G. Soledad Gonzalez and Angel Gallegos Freire, M.D., will provide the latest advancements in stem cell treatments and protocol for a variety of eye conditions and diseases including macular degeneration and retinitis pigmentosa, as well as the latest anti-aging and aesthetic treatments and therapies.

Soledad Gonzalez specializes in opthamology at the Laser Surgery Clinic in Higher Vision of Antofagasta since 2003, where he focuses on refractive surgery to treat conditions like myopia, hyperopia, astigmatism and presbyopia. He incorporated minimally invasive aesthetic medicine protocols to his practice in 2012 and specializes in the harvest, preparation, activation and application of stem cell therapies for a number of chronic degenerative diseases.

Gallegos Freire, Medical Director, Policlinico Bhpbilliton M: BHP Billiton Spencea in Ubicacin, Chile, specializing in aesthetic and anti-aging stem cell medicine. Gallegos Freire in an active member of the Argentina Society of Aesthetic Medicine (SOARME), Institutional Member of the Medical Association of Argentina (AMA), the Pan-American Society of Aesthetic Medicine (PASAM) and the Antiaging & Aesthetic Medicine International Society (AAAMISO).

The Antofagasta Regenestem clinic is the companys third international stem cell treatment center opened since Global Stem Cells Group opened the Regenestem Asia Clinic in Manila, Philippines in June and the Regenestem Mexico Clinic in Villahermosa Tabasco. These new, state-of-the-art regenerative medicine facilities join the company's growing global presence that includes clinics in Miami, New York, Los Angeles and Dubai. Regenestem Asia facility marks the first Regenestem brand clinic in the Philippines.

The Global Stem Cells Group and Regenestem are committed to providing the highest of standards in service and technology, expert and compassionate care, and a philosophy of exceeding the expectations of their international patients.

For more information, visit the Regenestem website, email info(at)regenstem(dot)com, or call 305-224-1858.

About Regenestem:

Regenestem, a division of the Global Stem Cells Group, Inc., provides stem cell treatments for a variety of diseases and conditions including arthritis, autism, chronic obstructive pulmonary disease (COPD), diabetes and multiple sclerosis at various facilities worldwide. Each Regenestem clinic offers an international staff experienced in administering the leading cellular therapies available.

Regenestem is certified for the medical tourism market, and staff physicians are board-certified or board-eligible. Regenestem clinics provide services in more than 10 specialties, attracting patients from the United States and around the world.

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Regenestem Names Renowned Stem Cell Specialists to Launch New Regenerative Medicine Clinic in Antofagasta, Northern ...