The DMC reviewed all of the accumulated safety data to date. The review included the safety data from six complete cervical injury (AIS-A) patients dosed with 10 million AST-OPC1 cells in Cohort 2, each of whom have completed at least six months of follow-up, as well as initial safety data from the currently enrolling Cohorts 3 and 4. Cohort 3 is enrolling AIS-A patients dosed with the highest dose of 20 million cells; Cohort 4 is testing 10 million cells in patients with less severe AIS-B incomplete cervical spinal cord injuries. In addition, the DMC reviewed the ongoing long-term safety data from the study's initial cohort of three patients dosed with 2 million cells, all of whom completed 12 months of follow-up in 2016.

As specified in the SCiStar study protocol, the DMC meets on a regular basis to review data from the ongoing trial. The DMC is comprised of an independent group of medical and scientific experts and is responsible for reviewing and evaluating patient safety and efficacy data for safeguarding the interest of study participants.

Asterias previously reported on positive early efficacy data from Cohort 2 (AIS-A; 10 million cells) of the SCiStar study. Patients from this cohort showed improvement in upper extremity motor function at 3-months following administration of AST-OPC1 and maintained or further increased this improvement at 6-months and 9-months. The results suggest a meaningful and favorable difference to date in recovery of arm, hand and finger function in patients treated with the 10 million cell dose of AST-OPC1 as compared to the level of expected rates of spontaneous recovery shown from historical control data of a closely matched patient population. Asterias expects to report additional efficacy and safety data for Cohort 2, as well as for the currently-enrolling Cohorts 3 and 4, later this year.

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 sub-acute, C-5 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 retain some minimal sensory function below their injury site. AST-OPC1 is being administered 14 to 30 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, 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. They also received low levels of immunosuppression for the next 60 days. Delivery of AST-OPC1 was successful in all five subjects with no serious adverse events associated with AST-OPC1. No evidence of rejection of AST-OPC1 was observed in detailed immune response monitoring of all patients. In four of the five patients, serial MRI scans indicated that reduced spinal cord cavitation may have occurred. Based on the results of this study, Asterias received clearance from FDA to progress testing of AST-OPC1 to patients with complete cervical spine injuries, which represents the first targeted population for registration trials.

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.

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SOURCE Asterias Biotherapeutics, Inc.

http://www.asteriasbiotherapeutics.com

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Asterias Biotherapeutics Announces Data Monitoring Committee Unanimously Recommends Continuation of SCiStar ... - PR Newswire (press release)

Spinal Cord Stem Cells Comments Off on Asterias Biotherapeutics Announces Data Monitoring Committee Unanimously Recommends Continuation of SCiStar … – PR Newswire (press release) | April 27th, 2017

The spinal cord is a rope of nerves relaying messages from the brain to every organ, muscle, and nerve ending in the body. The cells that make up the spinal cord arent a homogeneousmass, but rather a combination of dozens of specialized neurons, each with its own important role to play in guiding signals and impulses to the right destination.

This week, a team of California researchers announced the successful production of a lab-grown neuron that could help heal spinal cord injuries by reestablishing the connection between brain and muscle. In apaperpublished inProceedings of the National Academy of Sciences, researchers from the Gladstone Institutes and University of California campuses in San Francisco and Berkeley described how they grew human spinal cord neurons from stem cells and successfully introduced the lab-grown cells into the spines of healthy mice.

Todd McDevitt is a senior investigator at Gladstone and lead author of the study. He said that his team chose the targeted neuron, called a V2a interneuron, because it serves as a long relay cable between the neurons in the brain and the motor neurons that connect directly to muscle. V2a interneurons are, in fact, some of the longest cells in the body, able to extend their axon the nerve fibers that transmit electrical impulses across several vertebrae.

Its one cell stretching out up to 1,000 times longer than a normal human cell, said McDevitt. These outstretched neurons, as long as several centimeters, seem to play a critical role in relaying messages along the spinal cord. So if they are damaged in a traumatic injury, the brain-muscle connection may be severed, potentially leading to paralysis.

But if those critical V2a interneurons could be regenerated in an injured spine, the researchers wondered, perhaps the spinal cord could re-establish the connection and heal itself.

For the past three years, McDevitt and his team have been working to culture viable human V2a interneurons from pluripotent stem cells. The process, known as differentiation, attempts to replicate in the lab the natural development of neurons from undifferentiated stem cells in a human embryo.

Decades of research in developmental biology have provided clues to how genes in a developing embryo direct different proteins and other chemical factors to create all manner of specialized cells. The trouble is that most of the recipes for these chemical cocktails were derived from studying animal embryos.

Obviously, for good reasons, we dont do experiments on human embryos, McDevitt said. You have to take a leap of faith from the developmental biology knowledge we have from worms and flies and think about how we can apply that really important biological information to the human context.

RELATED:Brain Implant Helps 'Locked-In' ALS Woman Communicate

After experimenting with round after round of chemical combinations, the researchers landed on a process that can now produce a sizable batch of human V2a interneurons in a little over two weeks. The first step was to inject the cells into the spinal cords of healthy mice and see if the cells survived. They did even better.

Within two weeks, we saw a number of these cells extend their axons over long distances five millimeters reliably, but some even longer than that, McDevitt said, adding that the wiry cells are also making important connections. Even though theyre mice, we see these human cells that appear to be connecting to other neurons.

Does this mean were close to a human therapy using injections of healthy neurons to repair damaged spines? Not quite. Trials will first need to be run with injured mice before any human subjects can be tested. Plus, its entirely possible that V2a interneurons only fix very specific types of spinal injuries, or none at all. It might require the production of other spinal cord neurons, or a combination of several, to find the most effective treatment.

At the most basic level, this work shows that we can successfully introduce a new type of spinal neuron made from human pluripotent stem cells, McDevitt said. I see it as a step in whats probably going to be a much bigger effort by the field.

WATCH: Are We Close to Repairing Spinal Cord Injuries?

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Lab-Grown Neurons Could Help Heal Spinal Injuries and Restore Movement - Seeker

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Xianmin Zeng/Buck Inst.

Nerve cells derived from human stem cells, in work supported by the California Institute for Regenerative Medicine.

When California voters approved US$3billion in funding for stem-cell research in 2004, biologists flocked to the state, and citizens dreamed of cures for Parkinsons disease and spinal-cord injuries. Now, the pot of money one of the biggest state investments in science is running dry before treatments have emerged, raising questions about whether Californians will pour billions more into stem-cell research.

If they dont, that could leave hundreds of scientists without support, and strand potentially promising therapies before they reach the market. Its an issue of great concern, says Jonathan Thomas, chair of the board for the California Institute for Regenerative Medicine (CIRM) in Oakland.

CIRM is now doling out its final $650million, and its leaders are seeking money from the private sector to carry projects beyond 2020, when the money will run out. Advocates are also surveying voters to determine whether a new request for funding stands a chance in state elections next year. But critics argue against this way of funding research.

California voters saw major opportunities for stem cells in 2004 when they passed Proposition 71, which included an agreement to create the corporation that became CIRM. The move was a reaction to then-US president George W. Bushs decision in 2001 to restrict federal funds for work on human embryonic stem cells.

Since CIRM rolled out its first grants in 2006, it has funded more than 750 projects and reported alluring results from clinical trials. In March, a trial partially funded by CIRM showed that nine out of ten children born with severe combined immunodeficiency or bubble-boy disease a potentially lethal condition in which a persons immune system does not function properly, were doing well up to eight years after treatment (K.L.Shaw etal. J. Clin. Invest. http://doi.org/b6bp; 2017). They no longer need injections to be able to go to school, play outside or survive colds and other inevitable infections.

A dozen facilities constructed by CIRM have helped to push California to the forefront of research on ageing and regenerative medicine. Many grant recipients were early-career academics who had not been able to enter the stem-cell field previously because of the federal restrictions which were loosened in 2009 and the high cost of getting started in this kind of work. That barrier makes it difficult for researchers to gather the preliminary data typically required to win grants from the US National Institutes of Health (NIH).

To milk its remaining $650 million, CIRM partnered last year with the contract-research organization QuintilesIMS in Durham, North Carolina, to carry out clinical trials. CIRM leaders hope that this move will help to guide 40 novel therapies into trials by 2020.

Bob Klein, the property developer who put Proposition 71 on the ballot and established CIRM, isnt waiting for the money to run out. He leads an advocacy group, Americans for Cures, which will soon poll voters to see whether they would approve another $5 billion in funding. If it looks like at least 70% of Californians support that plan, hell start a campaign to put another initiative on the ballot in 2018.

Klein hopes that Californians will rise in support of science at a time when the Trump administration has proposed drastic cuts to the NIH budget. If public enthusiasm is not so strong, Klein says, hell aim for the 2020 elections, when voter turnout should be higher because it will coincide with the next presidential race.

Currently, CIRMs leaders are seeking other sources of support. The majority of our projects will not be ripe for interest from big pharma and the venture-capitalist community by the time we run out of funds, Thomas says. He has been courting large philanthropic foundations and wealthy individuals to raise money to continue the work.

John Simpson, who directs stem-cell oversight work at the advocacy group Consumer Watchdog in Washington DC, plans to oppose any effort to extend CIRM. I acknowledge their scientific advances, but we should not let a flawed process go further, he says. Simpson dislikes the model of using a vote to secure research funding through public bonds, because then the state lacks budgetary control.

Oversight of CIRM has been a problem in the past. In 2012, the US Institute of Medicine found that some scientists vetting grant proposals for CIRM had conflicts of interest. In response, CIRM altered its procedures but the public still felt betrayed. Jim Lott, a member of the state board that oversees CIRMs finances, says that he is not satisfied with the changes. He also argues that CIRM may not have been strategic enough in directing research. Some people say if they had a better focus, they might have achieved cures.

But researchers argue that expectations for cures after only a decade are unrealistic, given the typical pace of drug development. It would be a catastrophe for California if people say CIRM did not do what it was expected to do, says Eric Verdin, president of the Buck Institute for Research on Aging in Novato, California. Theyve built the foundation for the field and attracted people from around the world you cant just now pull the plug.

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California's $3-billion bet on stem cells faces final test : Nature News ... - Nature.com

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Science Daily

Discovery offers new hope to repair spinal cord injuries: Scientists ... Science Daily Scientists have created a special type of neuron from human stem cells that could potentially repair spinal cord injuries. These cells, called V2a interneurons, ... and more »

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Discovery offers new hope to repair spinal cord injuries: Scientists ... - Science Daily

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WSU student fractured spine at Oxford party

Ryan Custer, a Wright State University student who was severely injured at an Oxford party, is being considered for a stem cell study at Rush University Hospital in Chicago. The 19-year-old, a first-year forward for the Raiders varsity basketball team, will be evaluated for five days before doctors determine if he qualifies for the study.

Custer suffered a severe spinal injury after jumping into a makeshift pool at a party on S. Main Street on Saturday, April 8. Custer collided with another persons knee when he slid into the pool, causing the injury. Custer was immediately transported to the University of Cincinnati Medical Center where he underwent surgery on his spine that night.

Feeling in Custers legs has not returned, and he has only recently regained some movement in his fingers.

Custer was transported from the UC Medical Center to Rush Hospital on Sunday, April 22. According to a post from the Ryan Custer Recovery Care Page, a Facebook page updated almost daily by Custers family, he spent the first day in Chicago getting acclimated in his new room in Rushs ICU and meeting the doctor who will lead the study, Dr. Richard Fessler.

Dr. Fessler, a renowned spinal surgeon, has focused his research on developing and refining new ways to perform minimally invasive spinal surgeries. In 2010, Fessler performed surgery on former Indianapolis Colts quarterback Peyton Manning, which Custer was happy to learn, the post said.

The five-day period of testing began Monday, and, if selected for the study, treatment for Custer will begin on Friday. The study, called the SCiStar study, will evaluate how the injection of AST-OPC1, particular neural cells produced from human embryonic stem cells, at a single time 14 to 30 days after an injury can benefit the patients recovery.

According to the SCiStar webpage, the studys researchers are seeking adults between the ages of 18 and 69 who recently experienced a spinal cord injury in the neck which resulted in a loss of feeling below the site of the injury in addition to some paralysis in the arms and legs.

HBO has contacted Dr. Fessler about following a patient through this research process.

Ryan thinks it would be cool to do it, so we said yes,an April 22 Facebook post reads. Another step in the plan God has mapped out for Ryan.

A fundraising page created for Custer, The Ryan Custer 33 Recovery Fund, is close to raising its entire $100,000 goal. At the time of publication, the fund was just about $4,000 shy of the 100k mark.

Over 6,500 people have liked the page and are following along with Custers recovery through the familys Facebook updates.

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Custer considered for stem cell study | The Miami Student - Miami Student

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By Marilynn Marchione The Associated Press

Tummy tucks really hurt. Doctors carve from hip to hip, slicing off skin, tightening muscles, tugging at innards.

Patients often need strong painkillers for days or even weeks, after the procedure but Mary Hernandez went home on just over-the-counter ibuprofen.

The reason could be the yellowish goo smeared on her 18-inch wound as she lay on the operating table. The Houston woman was helping test a novel medicine aimed at avoiding opioids, potent pain relievers fueling an epidemic of overuse and addiction.

Vicodin, OxyContin and similar drugs are widely used for bad backs, severe arthritis, damaged nerves and other ailments. They work powerfully in brain areas that control pleasure and pain, but the body adapts to them quickly, so people need higher and higher doses to get relief.

This growing dependence on opioids has mushroomed into a national health crisis, ripping apart communities and straining police and health departments.

Every day, an overdose of prescription opioids or heroin kills 91 people, and legions more are brought back from the brink of death. With some 2 million Americans hooked on these pills, evidence is growing that theyre not as good a choice for treating chronic pain as once thought.

Drug companies are working on alternatives, but have had little success.

Twenty or so years ago, they invested heavily and failed miserably, said Dr. Nora Volkow, director of the National Institute on Drug Abuse.

Pain is a pain to research. Some people bear more than others, and success cant be measured as objectively as it can be with medicines that shrink a tumor or clear an infection. Some new pain drugs that worked well were doomed by side effects Vioxx, for example, helped arthritis but hurt hearts.

Some fresh approaches are giving hope:

Bespoke drugs, as Volkow calls them. These target specific pathways and types of pain rather than acting broadly in the brain. One is Enbrel, which treats a key feature of rheumatoid arthritis and, in the process, eases pain.

Drugs to prevent the need for opioids. One that Hernandez was helping test numbs a wound for a few days and curbs inflammation. If people dont have big pain after surgery, their nerves dont go on high alert and theres less chance of developing chronic pain that might require opioids.

Funky new sources for medicines. In testing: Drugs from silk, hot chili peppers and the venom of snakes, snails and other critters.

Novel uses for existing drugs. Some seizure and depression medicines, for example, can help some types of pain.

The biggest need, however, is for completely new medicines that can be used by lots of people for lots of problems. These also pose the most risk for companies and patients alike.

Bumpy road

In the early 2000s, a small biotech company had a big idea: blocking nerve growth factor, a protein made in response to pain.

The companys drug, now called tanezumab, works on outlying nerves, helping to keep pain signals from muscles, skin and organs from reaching the spinal cord and brain good for treating arthritis and bad backs.

Pfizer Inc. bought the firm in 2006 and expanded testing. But in 2010, some people on tanezumab and similar drugs being tested by rivals needed joint replacements.

Besides dulling pain, nerve growth factor might affect joint repair and regeneration, so a possible safety issue needed full investigation in a medicine that would be the first of its type ever sold, said one independent expert, Dr. Jianguo Cheng, a Cleveland Clinic pain specialist and science chief for the American Academy of Pain Medicine.

Regulators put some of the studies on hold. Suddenly, some people who had been doing well on tanezumab lost access to it. Phyllis Leis in Waterfall, a small town in south-central Pennsylvania, was one.

I was so angry, she said. That was like a miracle drug. It really was. Unless you have arthritis in your knees and have trouble walking, youll never understand how much relief and what a godsend it was.

Her doctor, Alan Kivitz of the Altoona Center for Clinical Research, has helped run hundreds of pain studies and consults for Pfizer and many other companies.

You rarely get people to feel that good as many of them did on the nerve growth factor drugs, he said.

A drug with that much early promise is unusual, said Ken Verburg, who has led Pfizers pain research for several decades. When you do see one, you fight hard to try to bring one to the market, he said.

An independent review ultimately tied just a few serious joint problems to tanezumab and the suspension on testing was lifted in August 2012. But a new issue nervous system effects in some animal studies prompted a second hold later that year, and that wasnt lifted until 2015.

Now, Eli Lilly & Co. has joined Pfizer in testing tanezumab in late-stage studies with 7,000 patients. Results are expected late next year about 17 years after the drugs conception.

Avoiding pain

What if a drug could keep people from needing long-term pain relief in the first place? Heron Therapeutics Inc. is testing a novel, long-acting version of two drugs the anesthetic bupivacaine and the anti-inflammatory meloxicam for notoriously painful operations such as tummy tucks, bunion removal and hernia repair.

Company studies suggest it can numb wounds for about three days and cut patients need for opioids by 30 to 50 percent.

Theres a good chance of preventing brain responses that lead to chronic pain if patients can get through that initially very rough period, said Dr. Harold Minkowitz, a Houston anesthesiologist who consults for Heron and treated Hernandez in the tummy tuck study.

Hernandez was part of an experiment testing the drug vs. a placebo and doesnt know whether she got the drug or a dummy medicine. But she hurt less than she expected to and never filled a prescription for pain pills.

The goal would be to have half or more of patients not requiring an opiate after they go home, said Herons chief executive, Barry Quart. You have far fewer opiates going out into society, far fewer opiates sitting in medicine cabinets that make their way to a high school.

Studies so far are mid-stage too small to prove safety and effectiveness but Heron plans more aimed at winning approval.

On the horizon

Many companies have their eyes on sodium channel blockers, which affect how nerves talk to one another and thus might help various types of pain. Others are testing cell therapies for nerve pain. Stem cells can modulate immune responses and inflammation, and might overcome a raft of problems, said Cheng of the pain medicine academy.

Some companies, including Samumed, Centrexion Therapeutics and Flexion Therapeutics, are testing long-acting medicines to inject in knees to relieve arthritis pain. Samumeds aims to regenerate cartilage.

And then theres marijuana. A cannabis extract is sold as a mouth spray in Britain for nerve pain and other problems from multiple sclerosis. But cannabinoid research in the United States has been hampered by marijuanas legal status. A special license is needed and most researchers dont even try to obtain one, said Susan Ingram, a neurosurgery scientist at Oregon Health & Science University.

She is studying cannabinoid receptors in the brain, looking at how pain affects one type but not another. Such work might someday lead to drugs that relieve pain but dont produce a high or addiction.

Selective activity has precedent: The drug buprenorphine partially binds to opioid receptors in the brain and has become an extraordinarily successful medication for treating addiction, said Volkow, of the national drug institute.

It has shown pharmaceutical companies that if you come up with a good intervention, there is an opportunity to recover their costs, she said.

Tummy tucks really hurt. Doctors carve from hip to hip, slicing off skin, tightening muscles, tugging at innards. Patients often need strong painkillers for days or even weeks, after the procedure but Mary Hernandez went home on just over-the-counter ibuprofen. The reason could be the yellowish goo smeared on her 18-inch wound as she lay on the operating table. The Houston woman was helping test a novel medicine aimed at avoiding opioids, potent pain relievers fueling an epidemic of overuse and addiction. Vicodin, OxyContin and similar drugs are widely used for bad backs, severe arthritis, damaged nerves and other ailments. They work powerfully in brain areas that control pleasure and pain, but the body adapts to them quickly, so people need higher and higher doses to get relief. This growing dependence on opioids has mushroomed into a national health crisis, ripping apart communities and straining police and health departments. Every day, an overdose of prescription opioids or heroin kills 91 people, and legions more are brought back from the brink of death. With some 2 million Americans hooked on these pills, evidence is growing that theyre not as good a choice for treating chronic pain as once thought. Drug companies are working on alternatives, but have had little success. Twenty or so years ago, they invested heavily and failed miserably, said Dr. Nora Volkow, director of the National Institute on Drug Abuse. Pain is a pain to research. Some people bear more than others, and success cant be measured as objectively as it can be with medicines that shrink a tumor or clear an infection. Some new pain drugs that worked well were doomed by side effects Vioxx, for example, helped arthritis but hurt hearts. Some fresh approaches are giving hope: n Bespoke drugs, as Volkow calls them. These target specific pathways and types of pain rather than acting broadly in the brain. One is Enbrel, which treats a key feature of rheumatoid arthritis and, in the process, eases pain. n Drugs to prevent the need for opioids. One that Hernandez was helping test numbs a wound for a few days and curbs inflammation. If people dont have big pain after surgery, their nerves dont go on high alert and theres less chance of developing chronic pain that might require opioids. n Funky new sources for medicines. In testing: Drugs from silk, hot chili peppers and the venom of snakes, snails and other critters. n Novel uses for existing drugs. Some seizure and depression medicines, for example, can help some types of pain. The biggest need, however, is for completely new medicines that can be used by lots of people for lots of problems. These also pose the most risk for companies and patients alike.Subhead: Bumpy road In the early 2000s, a small biotech company had a big idea: blocking nerve growth factor, a protein made in response to pain. The companys drug, now called tanezumab, works on outlying nerves, helping to keep pain signals from muscles, skin and organs from reaching the spinal cord and brain good for treating arthritis and bad backs. Pfizer Inc. bought the firm in 2006 and expanded testing. But in 2010, some people on tanezumab and similar drugs being tested by rivals needed joint replacements. Besides dulling pain, nerve growth factor might affect joint repair and regeneration, so a possible safety issue needed full investigation in a medicine that would be the first of its type ever sold, said one independent expert, Dr. Jianguo Cheng, a Cleveland Clinic pain specialist and science chief for the American Academy of Pain Medicine. Regulators put some of the studies on hold. Suddenly, some people who had been doing well on tanezumab lost access to it. Phyllis Leis in Waterfall, a small town in south-central Pennsylvania, was one. I was so angry, she said. That was like a miracle drug. It really was. Unless you have arthritis in your knees and have trouble walking, youll never understand how much relief and what a godsend it was. Her doctor, Alan Kivitz of the Altoona Center for Clinical Research, has helped run hundreds of pain studies and consults for Pfizer and many other companies. You rarely get people to feel that good as many of them did on the nerve growth factor drugs, he said. A drug with that much early promise is unusual, said Ken Verburg, who has led Pfizers pain research for several decades. When you do see one, you fight hard to try to bring one to the market, he said. An independent review ultimately tied just a few serious joint problems to tanezumab and the suspension on testing was lifted in August 2012. But a new issue nervous system effects in some animal studies prompted a second hold later that year, and that wasnt lifted until 2015. Now, Eli Lilly & Co. has joined Pfizer in testing tanezumab in late-stage studies with 7,000 patients. Results are expected late next year about 17 years after the drugs conception.Subhead: Avoiding pain What if a drug could keep people from needing long-term pain relief in the first place? Heron Therapeutics Inc. is testing a novel, long-acting version of two drugs the anesthetic bupivacaine and the anti-inflammatory meloxicam for notoriously painful operations such as tummy tucks, bunion removal and hernia repair. Company studies suggest it can numb wounds for about three days and cut patients need for opioids by 30 to 50 percent. Theres a good chance of preventing brain responses that lead to chronic pain if patients can get through that initially very rough period, said Dr. Harold Minkowitz, a Houston anesthesiologist who consults for Heron and treated Hernandez in the tummy tuck study. Hernandez was part of an experiment testing the drug vs. a placebo and doesnt know whether she got the drug or a dummy medicine. But she hurt less than she expected to and never filled a prescription for pain pills. The goal would be to have half or more of patients not requiring an opiate after they go home, said Herons chief executive, Barry Quart. You have far fewer opiates going out into society, far fewer opiates sitting in medicine cabinets that make their way to a high school. Studies so far are mid-stage too small to prove safety and effectiveness but Heron plans more aimed at winning approval.Subhead: On the horizon Many companies have their eyes on sodium channel blockers, which affect how nerves talk to one another and thus might help various types of pain. Others are testing cell therapies for nerve pain. Stem cells can modulate immune responses and inflammation, and might overcome a raft of problems, said Cheng of the pain medicine academy. Some companies, including Samumed, Centrexion Therapeutics and Flexion Therapeutics, are testing long-acting medicines to inject in knees to relieve arthritis pain. Samumeds aims to regenerate cartilage. And then theres marijuana. A cannabis extract is sold as a mouth spray in Britain for nerve pain and other problems from multiple sclerosis. But cannabinoid research in the United States has been hampered by marijuanas legal status. A special license is needed and most researchers dont even try to obtain one, said Susan Ingram, a neurosurgery scientist at Oregon Health & Science University. She is studying cannabinoid receptors in the brain, looking at how pain affects one type but not another. Such work might someday lead to drugs that relieve pain but dont produce a high or addiction. Selective activity has precedent: The drug buprenorphine partially binds to opioid receptors in the brain and has become an extraordinarily successful medication for treating addiction, said Volkow, of the national drug institute. It has shown pharmaceutical companies that if you come up with a good intervention, there is an opportunity to recover their costs, she said.

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Researchers look for new ways to reduce suffering, end addiction ... - The Columbus Dispatch

Spinal Cord Stem Cells Comments Off on Researchers look for new ways to reduce suffering, end addiction … – The Columbus Dispatch | April 23rd, 2017

By Marilynn MarchioneAP Chief Medical Writer

Tummy tucks really hurt. Doctors carve from hip to hip, slicing off skin, tightening muscles, tugging at innards. Patients often need strong painkillers for days or even weeks, but Mary Hernandez went home on just over-the-counter ibuprofen.

The reason may be the yellowish goo smeared on her 18-inch wound as she lay on the operating table. The Houston woman was helping test a novel medicine aimed at avoiding opioids, potent pain relievers fueling an epidemic of overuse and addiction.

Vicodin, OxyContin and similar drugs are widely used for bad backs, severe arthritis, damaged nerves and other woes. They work powerfully in brain areas that control pleasure and pain, but the body adapts to them quickly, so people need higher and higher doses to get relief.

This growing dependence on opioids has mushroomed into a national health crisis, ripping apart communities and straining police and health departments. Every day, an overdose of prescription opioids or heroin kills 91 people, and legions more are brought back from the brink of death. With some 2 million Americans hooked on these pills, evidence is growing that they're not as good a choice for treating chronic pain as once thought.

Drug companies are working on alternatives, but have had little success.

Twenty or so years ago, they invested heavily and "failed miserably," said Dr. Nora Volkow, director of the National Institute on Drug Abuse.

Pain is a pain to research. Some people bear more than others, and success can't be measured as objectively as it can be with medicines that shrink a tumor or clear an infection. Some new pain drugs that worked well were doomed by side effects Vioxx, for instance, helped arthritis but hurt hearts.

Some fresh approaches are giving hope:

"Bespoke" drugs, as Volkow calls them. These target specific pathways and types of pain rather than acting broadly in the brain. One is Enbrel, which treats a key feature of rheumatoid arthritis and, in the process, eases pain.

Drugs to prevent the need for opioids. One that Hernandez was helping test numbs a wound for a few days and curbs inflammation. If people don't have big pain after surgery, their nerves don't go on high alert and there's less chance of developing chronic pain that might require opioids.

Funky new sources for medicines. In testing: Drugs from silk, hot chili peppers and the venom of snakes, snails and other critters.

Novel uses for existing drugs. Some seizure and depression medicines, for example, can help some types of pain.

The biggest need, however, is for completely new medicines that can be used by lots of people for lots of problems. These also pose the most risk for companies and patients alike.

One drug's bumpy road

In the early 2000s, a small biotech company had a big idea: blocking nerve growth factor, a protein made in response to pain. The company's drug, now called tanezumab (tah-NAZE-uh-mab), works on outlying nerves, helping to keep pain signals from muscles, skin and organs from reaching the spinal cord and brain good for treating arthritis and bad backs.

Pfizer Inc. bought the firm in 2006 and expanded testing. But in 2010, some people on tanezumab and similar drugs being tested by rivals needed joint replacements. Besides dulling pain, nerve growth factor may affect joint repair and regeneration, so a possible safety issue needed full investigation in a medicine that would be the first of its type ever sold, said one independent expert, Dr. Jianguo Cheng, a Cleveland Clinic pain specialist and science chief for the American Academy of Pain Medicine.

Regulators put some of the studies on hold. Suddenly, some people who had been doing well on tanezumab lost access to it. Phyllis Leis in Waterfall, a small town in south-central Pennsylvania, was one.

"I was so angry," she said. "That was like a miracle drug. It really was. Unless you have arthritis in your knees and have trouble walking, you'll never understand how much relief and what a godsend it was."

Her doctor, Alan Kivitz of Altoona Center for Clinical Research, has helped run hundreds of pain studies and consults for Pfizer and many other companies. "You rarely get people to feel that good" as many of them did on the nerve growth factor drugs, he said.

A drug with that much early promise is unusual, said Ken Verburg, who has led Pfizer's pain research for several decades.

"When you do see one, you fight hard to try to bring one to the market," he said.

An independent review ultimately tied just a few serious joint problems to tanezumab and the suspension on testing was lifted in August 2012. But a new issue nervous system effects in some animal studies prompted a second hold later that year, and that wasn't lifted until 2015.

Now Eli Lilly & Co. has joined Pfizer in testing tanezumab in late-stage studies with 7,000 patients. Results are expected late next year about 17 years after the drug's conception.

Avoiding pain to avoid drugs

What if a drug could keep people from needing long-term pain relief in the first place? Heron Therapeutics Inc. is testing a novel, long-acting version of two drugs the anesthetic bupivacaine and the anti-inflammatory meloxicam for notoriously painful operations like tummy tucks, bunion removal and hernia repair.

Company studies suggest it can numb wounds for about three days and cut patients' need for opioids by 30 percent to 50 percent.

There's a good chance of preventing brain responses that lead to chronic pain if patients can get through that "initially very rough period," said Dr. Harold Minkowitz, a Houston anesthesiologist who consults for Heron and treated Hernandez in the tummy tuck study.

Hernandez was part of an experiment testing the drug versus a placebo and doesn't know whether she got the drug or a dummy medicine. But she hurt less than she expected to and never filled a prescription for pain pills.

"The goal would be to have half or more of patients not requiring an opiate after they go home," said Heron's chief executive, Barry Quart. "You have far fewer opiates going out into society, far fewer opiates sitting in medicine cabinets that make their way to a high school."

Studies so far are mid-stage too small to prove safety and effectiveness but Heron plans more aimed at winning approval.

On the horizon

Many companies have their eyes on sodium channel blockers, which affect how nerves talk to each other and thus might help various types of pain. Others are testing cell therapies for nerve pain. Stem cells can modulate immune responses and inflammation, and may "overcome a raft of problems," said Cheng of the pain medicine academy.

Some companies, including Samumed, Centrexion Therapeutics and Flexion Therapeutics, are testing long-acting medicines to inject in knees to relieve arthritis pain. Samumed's aims to regenerate cartilage.

And then there's marijuana. A cannabis extract is sold as a mouth spray in Britain for nerve pain and other problems from multiple sclerosis. But cannabinoid research in the United States has been hampered by marijuana's legal status. A special license is needed and most researchers don't even try to obtain one, said Susan Ingram, a neurosurgery scientist at Oregon Health & Science University.

She is studying cannabinoid receptors in the brain, looking at how pain affects one type but not another. Such work might someday lead to drugs that relieve pain but don't produce a high or addiction.

Selective activity has precedent: The drug buprenorphine partially binds to opioid receptors in the brain and has become "an extraordinarily successful medication" for treating addiction, said Volkow, of the national drug institute.

"It has shown pharmaceutical companies that if you come up with a good intervention, there is an opportunity to recover their costs," she said.

Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP

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The quest for less addictive drugs - Foster's Daily Democrat

Spinal Cord Stem Cells Comments Off on The quest for less addictive drugs – Foster’s Daily Democrat | April 23rd, 2017

Tummy tucks really hurt. Doctors carve from hip to hip, slicing off skin, tightening muscles, tugging at innards. Patients often need strong painkillers for days or even weeks, but Mary Hernandez went home on just over-the-counter ibuprofen.

The reason may be the yellowish goo smeared on her 18-inch wound as she lay on the operating table. The Houston woman was helping test a novel medicine aimed at avoiding opioids, potent pain relievers fueling an epidemic of overuse and addiction.

Vicodin, OxyContin and similar drugs are widely used for bad backs, severe arthritis, damaged nerves and other woes. They work powerfully in brain areas that control pleasure and pain, but the body adapts to them quickly, so people need higher and higher doses to get relief.

This growing dependence on opioids has mushroomed into a national health crisis, ripping apart communities and straining police and health departments. Every day, an overdose of prescription opioids or heroin kills 91 people, and legions more are brought back from the brink of death. With about

2 million Americans hooked on these pills, evidence is growing that theyre not as good a choice for treating chronic pain as once thought.

Drug companies are working on alternatives, but have had little success.

Twenty or so years ago, they invested heavily and failed miserably, said Dr. Nora Volkow, director of the National Institute on Drug Abuse.

Pain is a pain to research. Some people bear more than others, and success cant be measured as objectively as it can be with medicines that shrink a tumor or clear an infection. Some new pain drugs that worked well were doomed by side effects Vioxx, for instance, helped arthritis but hurt hearts.

Some fresh approaches are giving hope:

Bespoke drugs, as Volkow calls them. These target specific pathways and types of pain rather than acting broadly in the brain. One is Enbrel, which treats a key feature of rheumatoid arthritis and, in the process, eases pain.

Drugs to prevent the need for opioids. One that Hernandez was helping test numbs a wound for a few days and curbs inflammation. If people dont have big pain after surgery, their nerves dont go on high alert and theres less chance of developing chronic pain that might require opioids.

Funky new sources for medicines. In testing: Drugs from silk, hot chili peppers and the venom of snakes, snails and other critters.

Novel uses for existing drugs. Some seizure and depression medicines, for example, can help some types of pain.

The biggest need, however, is for completely new medicines that can be used by lots of people for lots of problems. These also pose the most risk for companies and patients alike.

ONE DRUGS BUMPY ROAD

In the early 2000s, a small biotech company had a big idea: blocking nerve growth factor, a protein made in response to pain.

The companys drug, now called tanezumab, works on outlying nerves, helping to keep pain signals from muscles, skin and organs from reaching the spinal cord and brain good for treating arthritis and bad backs.

Pfizer Inc. bought the firm in 2006 and expanded testing. But in 2010, some people on tanezumab and similar drugs being tested by rivals needed joint replacements. Besides dulling pain, nerve growth factor may affect joint repair and regeneration, so a possible safety issue needed full investigation in a medicine that would be the first of its type ever sold, said one independent expert, Dr. Jianguo Cheng, a Cleveland Clinic pain specialist and science chief for the American Academy of Pain Medicine.

Regulators put some of the studies on hold. Suddenly, some people who had been doing well on tanezumab lost access to it. Phyllis Leis in Waterfall, a small town in south-central Pennsylvania, was one.

I was so angry, she said. That was like a miracle drug. It really was. Unless you have arthritis in your knees and have trouble walking, youll never understand how much relief and what a godsend it was.

Her doctor, Alan Kivitz of Altoona Center for Clinical Research, has helped run hundreds of pain studies and consults for Pfizer and many other companies.

You rarely get people to feel that good as many of them did on the nerve growth factor drugs, he said.

A drug with that much early promise is unusual, said Ken Verburg, who has led Pfizers pain research for several decades.

When you do see one, you fight hard to try to bring one to the market, he said.

An independent review ultimately tied just a few serious joint problems to tanezumab and the suspension on testing was lifted in August 2012. But a new issue nervous system effects in some animal studies prompted a second hold later that year, and that wasnt lifted until 2015.

Now Eli Lilly & Co. has joined Pfizer in testing tanezumab in late-stage studies with 7,000 patients.

Results are expected late next year about 17 years after the drugs conception.

AVOIDING PAIN AND DRUGS

What if a drug could keep people from needing long-term pain relief in the first place? Heron Therapeutics Inc. is testing a novel, long-acting version of two drugs the anesthetic bupivacaine and the anti-inflammatory meloxicam for notoriously painful operations like tummy tucks, bunion removal and hernia repair.

Company studies suggest it can numb wounds for about three days and cut patients need for opioids by 30 to 50 percent.

Theres a good chance of preventing brain responses that lead to chronic pain if patients can get through that initially very rough period, said Dr. Harold Minkowitz, a Houston anesthesiologist who consults for Heron and treated Hernandez in the tummy tuck study.

Hernandez was part of an experiment testing the drug versus a placebo and doesnt know whether she got the drug or a dummy medicine. But she hurt less than she expected to and never filled a prescription for pain pills.

The goal would be to have half or more of patients not requiring an opiate after they go home, said Herons chief executive, Barry Quart. You have far fewer opiates going out into society, far fewer opiates sitting in medicine cabinets that make their way to a high school.

Studies so far are mid-stage too small to prove safety and effectiveness but Heron plans more aimed at winning approval.

ON THE HORIZON

Many companies have their eyes on sodium channel blockers, which affect how nerves talk to each other and thus might help various types of pain. Others are testing cell therapies for nerve pain. Stem cells can modulate immune responses and inflammation, and may overcome a raft of problems, said Cheng of the pain medicine academy.

Some companies, including Samumed, Centrexion Therapeutics and Flexion Therapeutics, are testing long-acting medicines to inject in knees to relieve arthritis pain. Samumeds aims to regenerate cartilage.

And then theres marijuana. A cannabis extract is sold as a mouth spray in Britain for nerve pain and other problems from multiple sclerosis. But cannabinoid research in the U.S. has been hampered by marijuanas legal status. A special license is needed and most researchers dont even try to obtain one, said Susan Ingram, a neurosurgery scientist at Oregon Health & Science University.

She is studying cannabinoid receptors in the brain, looking at how pain affects one type but not another. Such work might someday lead to drugs that relieve pain but dont produce a high or addiction.

Selective activity has precedent: The drug buprenorphine partially binds to opioid receptors in the brain and has become an extraordinarily successful medication for treating addiction, said Volkow, of the national drug institute.

It has shown pharmaceutical companies that if you come up with a good intervention, there is an opportunity to recover their costs, she said.

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Overcoming opioids: Quest for less addictive drugs - Mohave Valley News

Spinal Cord Stem Cells Comments Off on Overcoming opioids: Quest for less addictive drugs – Mohave Valley News | April 23rd, 2017

FINDINGS

New research by scientists at the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLAoverturns a long-standing paradigm about how axons thread-like projections that connect cells in the nervous system grow during embryonic development. The findings of the study, led by Samantha Butler, associate professor of neurobiology, could help scientists replicate or control the way axons grow, which may be applicable for diseases that affect the nervous system, such as diabetes, as well as injuries that sever nerves.

As an embryo grows, neurons the cells in the nervous system extend axons into the developing spinal cord. Axons are then guided to reach other areas of the body, such as the brain, to establish a functioning nervous system. It has been generally understood that various guidance cues, which are cellular molecules such as proteins, either attract or repel axon growth as the axons reach out from neurons to find their destination in the nervous system.

Previous research suggested that a particular guidance cue, called netrin1, functions over a long distance to attract and organize axon growth, similar to how a lighthouse sends out a signal to orient a ship from afar. However, previous research also shows that netrin1 is produced in many places in the embryonic spinal cord, raising questions about whether it really acts over a long distance. Most notably, netrin1 is produced by tissue-specific stem cells, called neural progenitors, which can create any cell type in the nervous system. Yet, it was not understood how the netrin1 produced by neural progenitors influences axon growth.

Butler and her research team removed netrin1 from neural progenitors in different areas in mouse embryonic spinal cords. This manipulation resulted in highly disorganized and abnormal axon growth, giving the researchers a very detailed view of how netrin1 produced by neural progenitors influences axons in the developing nervous system.

They found that neural progenitors organize axon growth by producing a pathway of netrin1 that directs axons only in their local environment and not over long distances. This pathway of netrin1 acts as a sticky surface that encourages axon growth in the directions that form a normal, functioning nervous system.

Butlers study is a significant reinterpretation of the role of netrin1 in nervous system formation. The results further scientists understanding of the contribution neural progenitors make to neural circuit formation. Determining how netrin1 specifically influences axon growth could help scientists use netrin1 to regenerate axons more effectively in patients whose nerves have been damaged.

For example, because nerves grow in channels, there is much interest in trying to restore nerve channels after an injury that results in severed nerves, which is seen often in patients who have experienced an accident or in veterans with injuries to their arms or legs. One promising approach is to implant artificial nerve channels into a person with a nerve injury to give regenerating axons a conduit to grow through. Butler believes that coating such nerve channels with netrin1 could further encourage axon regrowth. Her continued research will focus on uncovering more details about how netrin1 functions and how it could be used clinically.

Butler is the senior author of the study. The first author is Supraja Varadarajan, a graduate student in Butlers lab.

The study is published today in the journal Neuron.

The study was funded by grants from the National Institutes of Health (DK097075, HL098294, HL114457, DK082509 HL109233, DK109574, HL119837, NS072804, NS089817, NS063999, NS085097 and HL133900), the Canadian Institutes of Health Research (MOP-97758 and MOP-77556), Brain Canada, the Natural Sciences and Engineering Research Council of Canada, Canada Foundation for Innovation, the W. Garfield Weston Foundation, the March of Dimes Foundation (6-FY10-296 and 1-FY07-458) and the UCLA Broad Stem Cell Research Center.

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Study overturns seminal research about the developing nervous system - UCLA Newsroom

Spinal Cord Stem Cells Comments Off on Study overturns seminal research about the developing nervous system – UCLA Newsroom | April 21st, 2017

Science Daily

Study overturns seminal research about the developing nervous system Science Daily New research by scientists at the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA overturns a long-standing paradigm about how axons -- thread-like projections that connect cells in the nervous system -- grow during ... and more »

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Study overturns seminal research about the developing nervous system - Science Daily

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Zee News

24-year-old treated for multiple sclerosis The Hindu Kanika was diagnosed with multiple sclerosis, a disorder where the body's immune system starts attacking the protective sheet covering the nerve cells in the brain and spinal cord. After going through several rounds of treatments, ... Dr. Rahul ... Multiple Sclerosis patient successfully treated with bone marrow transplantBusiness Standard Diagnosed with multiple sclerosis, girl fights back | The Indian ExpressThe Indian Express Doctors successfully treat 24-year-old girl MS patient with bone marrow transplantZee News all 4 news articles »

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24-year-old treated for multiple sclerosis - The Hindu

Spinal Cord Stem Cells Comments Off on 24-year-old treated for multiple sclerosis – The Hindu | April 20th, 2017

WDTN	Ryan Custer may join stem cell study WDTN CINCINNATI, Ohio (WDTN) The Wright State basketball player who injured his spinal cord during an accident at a party this month is getting some much needed good news. According to a post on Facebook, Ryan Custer might be participating in a medical ...

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Ryan Custer may join stem cell study - WDTN

Spinal Cord Stem Cells Comments Off on Ryan Custer may join stem cell study – WDTN | April 18th, 2017

April 17, 2017 by Hannah L. Robbins SMN protein (red) is necessary for the survival of spinal cord neurons (motor neurons) responsible for breathing and all movement. Harvard researchers have found a compound that stabilized this protein in mouse and human motor neurons. This may lead to the development of new treatments for motor neuron diseases including Spinal Muscular Atrophy and Lou Gehrigs disease. Credit: Natalia Rodriguez-Muela

Harvard Stem Cell Institute (HSCI) researchers have identified a compound that helps protect the cells destroyed by spinal muscular atrophy (SMA), the most frequent fatal genetic disease in children under 2 years of age.

SMA is a neurodegenerative disease targeting motor neurons, the long nerve cells that relay messages from the brain to the muscles and that are, consequently, responsible for bodily movements, including walking, swallowing, and even breathing. Patients with milder forms of SMA experience muscle wasting that may confine them to a wheelchair, while the more severe forms cause paralysis and death before the second birthday.

About one in 50 people are genetic carriers of the disease.

Because of a dysfunctional gene, many motor neurons in SMA patients are unable to produce adequate amounts of a protein called survival of motor neuron (SMN). The deficiency causes cellular stress and eventually cell death. Rather than fixing the gene, which has been the strategy of many labs looking to develop SMA therapies, the Harvard team has identified a compound that helps stabilize the SMN protein both in human neurons in a dish and in mouse models.

The findings were published in the journal Cell Reports.

"This discovery opens up new lines of drug interrogation," said Lee Rubin, HSCI principal faculty member and the senior author on the study. Rubin's lab, which operates out of in Harvard's Department of Stem Cell and Regenerative Biology, uses induced pluripotent stem cells (iPS cells) to make human models of neurological diseases.

In 2015, Rubin made a variety of neuronal types from the iPS cells of SMA patients in order to determine why motor neurons in particular were targeted, and found they experienced a fatal stress response similar to motor neurons affected by amyotrophic lateral sclerosis (ALS), the late-onset neurodegenerative disease more commonly known as Lou Gehrig's disease.

Additionally, some SMA-affected motor neurons were dying before others, though all of the neurons had the same genetic mutations and were experiencing the same stressful environment.

"Clearly, some motor neurons were surviving, so the next question was whether this is random or if there is a molecular explanation," Rubin said.

Early on in their most recent study, the researchers found that within a single petri dish of motor neurons derived from an SMA patient, some produced up to four times as much SMN protein as their neighbors. Over time, those motor neurons with higher levels of SMN were more likely to survive after exposure to toxic environments and stressors.

When the team analyzed motor neurons derived from ALS patients, they found similar results: Motor neurons with higher levels of SMN were likelier to survive than those with lower levels.

"The surprise was when we looked in a control culture and also saw differences between the individual neurons," Rubin said.

"It is clear that the SMN protein is necessary for all motor neuron survival, not just motor neurons targeted by ALS or SMA," said Natalia Rodrguez-Muela, a postdoctoral fellow in Rubin's lab and co-first author on the paper. The results suggest that if the team could increase the amount of SMN protein in any single motor neuron, they would be able to rescue the cell.

During a cell's life span, proteins are constantly being made and degraded, made and degraded again. To interrupt the process of breaking down the SMN protein, the researchers looked at a family of proteins called Cullins, which act as a part of the cell machinery that regulates protein degradation.

In 2011, the Rubin lab had determined that an enzyme called GSK3b helps control SMN stability. Nearly all proteins degraded by GSK3b are flagged for degradation by a pathway that involves a specific member of the Cullin family. Rubin said the researchers hypothesized that if they could block that Cullin-mediated process, the SMN proteins would not be flagged for degradation and would remain stable longer.

The researchers, led by co-first author Nadia Litterman, then dosed human and murine motor neurons with a compound known to block the specific Cullin and found that exposure to the compound made SMN proteins more stable and more abundant. As a consequence, the compound promoted survival of all motor neurons, both in human cells in the dish and in mouse models.

Additionally, mice with SMA, even the more severe forms of the disease, had some of their symptoms improve after exposure to the compound.

"This process points to an unexplored therapeutic direction that could benefit patients of not one, but two separate diseases," Rubin said.

Explore further: Hope against disease targeting children

More information: Natalia Rodriguez-Muela et al. Single-Cell Analysis of SMN Reveals Its Broader Role in Neuromuscular Disease, Cell Reports (2017). DOI: 10.1016/j.celrep.2017.01.035

Journal reference: Cell Reports

Provided by: Harvard University

This story is published courtesy of the Harvard Gazette, Harvard University's official newspaper. For additional university news, visit Harvard.edu.

Harvard Stem Cell Institute (HSCI) researchers studying spinal muscular atrophy (SMA) have found what they term "surprising similarities" between this childhood disorder that attacks motor neurons and amyotrophic lateral ...

Using a new stem-cell based drug screening technology with the potential to reinvent and greatly reduce the cost of the way new pharmaceuticals are developed, Harvard Stem Cell Institute (HSCI) researchers have found a compound ...

Although only 10 percent of amyotrophic lateral sclerosis (ALS) cases are hereditary, a significant number of them are caused by mutations that affect proteins that bind RNA, a type of genetic material. University of California ...

A puzzling question has lurked behind SMA (spinal muscular atrophy), the leading genetic cause of death in infants.

New research from the Advanced Gene and Cell Therapy Lab at Royal Holloway, University of London has used pioneering stem cell techniques to better understand why certain cells are more at risk of degenerating in spinal muscular ...

Cedars-Sinai scientists are seeking to build an improved stem-cell model of amyotrophic lateral sclerosis (ALS) to accelerate progress toward a cure for the devastating neurological disorder. Their findings demonstrate that ...

A new study from the Icahn School of Medicine at Mount Sinai provides important insights into how the body regulates its production of heat, a process known as thermogenesis that is currently intensely studied as a target ...

Harvard Stem Cell Institute (HSCI) researchers have identified a compound that helps protect the cells destroyed by spinal muscular atrophy (SMA), the most frequent fatal genetic disease in children under 2 years of age.

Inflammatory bowel disease (IBD), characterized by chronic relapsing inflammation of the gut, is a common problem in the industrialized world. However, how IBD develops remains unknown. There is currently no cure and treatment ...

Muscles consume a large part of the body's energy. Hence when fat metabolism in muscle cells is impaired, the organism gains weight. Scientists from the Max Planck Institute for Heart and Lung Research in Bad Nauheim have ...

Scientists at the Gladstone Institutes and the University of California, San Francisco (UCSF), identified a common mechanism in two forms of neurodegeneration that affect young adults or the elderly. The discovery advances ...

Patients with colon and rectal cancer have somatic insertions of mitochondrial DNA into the nuclear genomes of the cancer cells, University of Alabama at Birmingham researchers report in the journal Genome Medicine.

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Scientists find evidence that ALS and SMA could be treated with a ... - Medical Xpress

Spinal Cord Stem Cells Comments Off on Scientists find evidence that ALS and SMA could be treated with a … – Medical Xpress | April 17th, 2017

A desperate mum-of-two says she is losing her memory so fast she may soon be unable to recognise her young daughters.

Chantelle Fox was diagnosed with multiple sclerosis (MS) last May after suffering fatigue and "a little numbness" in her arm.

Since the devastating diagnosis, the 41-year-old's condition has quickly deteriorated, leaving her fearful for the future.

She has 79 lesions on her brain and her short-term memory is fading, meaning she often forgets where she has put things.

She also forgets promising her "beautiful" daughters, Lilly, five, and Edie, three, that she will take them somewhere special.

Her worst fear is that in just four years, she may not even remember the little girls at all.

Now, she faces a race against time to fund radical stem cell treatment in Russia - which she believes could halt the progress of her disease.

MS is a chronic condition, for which there is currently no cure.

The disease is caused by the immune system malfunctioning and mistakenly attacking nerve cells in the brain and spinal cord.

It can lead to patients suffering from a range of mild or severe symptoms.

In a bid to stop the progress of the "monster" condition, Chantelle, from Australia, plans to undergo surgery in Moscow.

MS Australia has deemed the treatment risky, while one neurologist told the mum there is no evidence it works and it could be dangerous.

However, another neurologist reportedly told her she would be a great candidate for a haematopoietic stem cell transplant (HSCT) trial.

But Chantelle, who lives in Melbourne, said waiting a long time for the chance to take part in a clinical trial in her home country wasn't an option.

Instead, she plans to travel abroad in June to undergo surgery.

I have two beautiful kids and I might not remember them in four years time if I dont go to Russia," she told the Herald Sun .

She added: I have to fight for my kids. I want to help them study, to see them married, to be a grandparent."

Chantelle has been accepted into an autologous haematopoietic stem cell transplant programme in Moscow.

She claimed the treatment has an "86 per cent success rate" in halting the progress of the neurological condition.

However, her family said the costs involved are "crippling".

They are trying to raise $150,000 (120,000) to cover the price of the treatment and transport to and from Russia.

Chantelle's sister, Maxine Parker, has set up dedicated GoFundMe and Facebook pages to help raise money for the surgery.

On the GoFundMe page, she describes how her younger sibling was "devastated" when she was diagnosed with MS.

She writes: "Chantelle was first diagnosed in May 2016. What started out as fatigue and a little numbness in her left arm, she put it down to just being tired from being a full time working mum of two young girls...

"A trip to her doctor one Sunday afternoon changed her and her family life forever. She was told to head straight to hospital, the dr believes she may have had a minor stroke.

"24 hours later, sitting in the hospital bed the neurologist suggests its either a brain tumour, motor neurone disease or MS and the only way to confirm is with a lumbar puncture and full MRI of her brain & spine.

"I will never forget sitting there holding my baby sister's hand as she lays on the bed with the nurse injecting a large needle into her spine to obtain spinal fluid. Almost an hour and half goes by and they confirm its been unsuccessful and they will need to try again.

"Next is the MRI and after two hours my sister returns to her hospital bed waiting for the news that will change her life forever."

She adds: "That neurologist returns to deliver the news, Chantelle you have multiple sclerosis... Chantelle is devastated, all she can think about is her two young girls and if she will be around to watch them grow up."

In a post on the page, Chantelle herself pays tribute to her sister, her husband Dara O'Donoghue and her two little girls.

Addressing Lilly and Edie, she writes: "You are the reason, I will never give up fighting this terrible disease, MS.

"You are my world and I will love you for eternity."

She also expresses her gratitude to her other relatives and friends.

It is estimated that around 100,000 people in the UK have MS.

HSCT involves the intravenous infusion of stem cells derived from peripheral blood, bone marrow or umbilical cord blood.

In autologous cases, the patient's own stem cells are used.

Their immune system is usually wiped out with chemotherapy treatment before it is regrown using their stem cells.

To visit Chantelle's GoFundMe page, click here .

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Desperate mum's race against time to fund treatment before she forgets her two little girls - Mirror.co.uk

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A quick glance at your calendar will reveal that we're now in 2017. 2017, you may recall, is the year when contraversial surgeon Sergio Canavero has promised to perform the world's first human head transplant.

But just how feasible is a human head transplant? Is it the stuff of science fiction, or does it have a basis in current sceintific thinking? Read on for everything you need to know about 2017 most alarming scientific development.

A human head transplant is exactly what it sounds like taking one living head and putting it onto a new body.

But actually, thats a little misleading. In real terms, its a body transplant, as the head will be gaining a new body to control. However, as the term whole body transplant is already used to mean transferring the brain between bodies, calling it a head transplant makes it clear that the whole head is to be switched, brain included.

Until recently, a head transplant seemed totally implausible, but the Italian scientist Dr Sergio Canavero believes its possible, and intends to conduct the first surgery in 2017.

Canavero outlines the procedure in detail here, but these are the basics of the process. Remember: dont try this at home, kids.

The donor body and the head to be attached are first cooled down to 12-15C to ensure that the cells last longer than a few minutes without oxygen. The tissue around the neck is then cut, with the major blood vessels linked with tiny tubes. The spinal cord on each party is then severed cleanly with an extremely sharp blade.

"Post coma, Canavero believes the patient would immediately be able to move, feel their face and even speak with the same voice."

At this point, the head is ready to be moved, and the two ends of the spinal cord are fused using a chemical called polyethylene glycol, encouraging the cells to mesh. This chemical has been shown to prompt the growth of spinal cord nerves in animals, although Canavero suggests that introducing stem cells or olfactory ensheathing cells into the spinal cord could also be tried.

After the muscles and blood supply are successfully connected, the patient is kept in a coma for a month to limit movement of the newly fused neck, while electrodes stimulate the spinal cord to strengthen its new connections.

Following the coma, Canavero anticipates that the patient would immediately be able to move, feel their face and even speak with the same voice. He believes physiotherapy would allow the patient to walk within a year.

He explains his suggested methods in the TED talk below.

Sceptical would be a nice way of putting it. Horrified would, in most cases, be more accurate.

Dr Hunt Batjer has attracted headlines for being particularly blunt: I would not wish this on anyone. I would not allow anyone to do it to me as there are a lot of things worse than death.

Dr Jerry Silver witnessed the 1970s monkey head transplant experiment more on which later and describes the procedure as bad science, adding that just to do the experiments is unethical. This is a particular blow to Canavero, as he states that Silvers own work in reconnecting rats spinal cords should give hope to the human head transplant. Silver dismisses this: To sever a head and even contemplate the possibility of gluing axons back properly across the lesion to their neighbours is pure and utter fantasy in my opinion.

Dr Chad Gordon, professor of plastic and reconstructive surgery and neurological surgery at Johns Hopkins University, agrees that Canaveros claims are scientifically implausible. He told BuzzFeed: Theres no way hes going to hook up somebodys brain to someones spinal cord and have them be functional.

On the conservative side, were about 100 years away from being able to figure this out, he continued. If hes saying two, and hes promising a living, breathing, talking, moving human being? Hes lying.

Dr Paul Myers, associate professor of biology at the University of Minnesota at Morris, puts it even more explicitly: This procedure will not work... Try it with monkeys first. But he cant: the result would be, at best, a shambling horror, an animal driven mad with pain and terror, crippled and whimpering, and a poor advertisement for his experiment. And most likely what hed have is a collection of corpses that suffered briefly before expiring.

Others wonder whether Canavero might simply be enjoying the limelight with a PR stunt, including Dr Arthur Caplan, director of ethics at the NYU Langone Medical Centre. Describing the doctor as nuts, he explained to CNN: Their bodies would end up being overwhelmed with different pathways and chemistry than theyre used to, and theyd go crazy.

"We'll probably see a head on a robot before we see it on [another] body," he told Live Science.

Dr John Adler of Stanford University's school of medicine is slightly more optimistic... but not much more. "Conceptually, much of this could work, but the most favourable outcome will be little more than a Christopher Reeve level of function," he told Newsweek.

Canavero is aware of this criticism, claiming that silently hes received a lot of support from the medical community. Of Dr Batjers comments that the surgery would be a fate worse than death, Canavero is scathing. Hes a vascular surgeon. A vascular surgeon of the brain, yes, but he knows nothing, he argued. How can you say such a thing? Its incredible.

"The world is moving, the critics are dwindling. Of course, there will always be critics. Science teaches us that when you propose something groundbreaking, you must be confronted by criticism. If no critics really step forward, you are saying nothing special," he told Medical News Today.

No-one has ever attempted a human head transplant before, and attempts on animals have to put it charitably had limited success.

Image: from Motherboard, uploaded under fair use from a 1959 issue of Life

The photo above really does show a dog with two heads and its not a fake. This was the work of Soviet scientist Vladimir Demikhov, and for four days the hybrid of two dogs lived as normally as such a scientific horror could be expected to. Then they died.

Demikhov tried the experiment more than 24 times, but was unable to find a way of avoiding the dogs dying shortly after surgery. Although the results are horrifying to see, Demikhovs research did pave the way for human organ transplants.

"For four days this hybrid of two dogs lived as normally as such a scientific horror could be expected to. Then they died."

But back to the topic of head transplants. The first time a straight swap was successful, was by Dr Robert White, in an experiment on a rhesus monkey in 1970. I feel the need to qualify the word successful with quotation marks, because although the monkey did live, he didnt live very long. Eight days, to be exact, and as the spinal cord wasnt attached to its new body, the monkey was paralysed for its remaining days. However, it could indeed see, hear, smell and taste before the body rejected the foreign head.

According to Canavero in his paper on human head transplants, the monkey lived eight days and was, by all measures, normal, having suffered no complications. However, Dr Jerry Silver who worked in the same lab as Dr White has more haunting memories. He toldCBS: I remember that the head would wake up, the facial expressions looked like terrible pain and confusion and anxiety in the animal. The head will stay alive, but not very long. It was just awful. I dont think it should ever be done again.

More recently, Chinese doctor Xiaoping Ren claims to have conducted head transplants on more than 1,000 mice. The Wall Street Journal reports to have witnessed a mouse with a new head moving, breathing, looking around and drinking. But, crucially, none of these mice have lived longer than a few minutes.

Still, Dr Rens studies continue, and the latest reports are said to be promising, offering a possible answer to the risk of severe blood loss (or brain ischemia) during transplantation. The experimental method that we have described can allow for long-term survival, and thus assessment of transplant rejection and central nervous system recovery, bringing us one step closer to AHBR in man, the researchers wrote.

Ren himself has not ruled out taking part in the first human head transplant operation, according to the Daily Mail. "A human head transplant will be a new frontier in science. Some people say it is the last frontier in medicine. It is a very sensitive and very controversial subject but if we can translate it to clinical practice, we can save a lot of lives," he said.

"Many people say a head transplant is not ethical. But what is the essence of a person? A person is the brain not the body. The body is just an organ," he added.

In January 2016, Canavero told New Scientist that a head transplant had been successfully completed on a monkey in China, although details were sparse. "The monkey fully survived the procedure without any neurological injury of whatever kind," he said, although the article notes that the monkey only kept alive for 20 hours after the surgery for "ethical reasons," limiting its use as a comparison somewhat.

In September 2016, Canavero revealeda further trial of the head transplant on dogs.New Scientisthas seen video footage of a dog appearing to walk three weeks after its spinal cord was severed, with Canavero claiming that the outcome is the result of the same techniques he plans to use on Spiridonov next year.

However, speaking to a number of scientists for their view on the new evidence, New Scientistcould find few sceptics converted. "These papers do not support moving forward in humans," said Jerry Silver a neuroscientist at Cape Western Reserve University in Ohio.

"The dog is a case report, and you cant learn very much from a single animal without controls. They claim they cut the cervical cord 90 per cent but theres no evidence of that in the paper, just some crude pictures," added Silver.

You could say so, though Canavero doesn't see it quite like that. In fact, controversially he sees it more as a failure of other types of medicine, telling Medical News Today, "It will be about curing incurable neurological disorders for which other treatments have failed big time, so gene therapy,stem cells- they all just came to nothing. We have failed despite billions of dollars being poured into this sort of research."

"So actually, head transplant or body transplant, whatever your angle is, is actually a failure of medicine. It is not a brilliant success, a brilliant advancement to medical science. When you just haven't tackled biology, you don't know how to treat genes, you don't really understand, and you really need to resort to a body transplant, it means that you've failed. So this must not be construed as a success of medical research," he added.

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Human head transplant: Sergio Canavero considers the UK as the venue for 2017's most talked about operation - Alphr

Spinal Cord Stem Cells Comments Off on Human head transplant: Sergio Canavero considers the UK as the venue for 2017’s most talked about operation – Alphr | April 14th, 2017

GERMANTOWN, Md., April 12, 2017 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (CUR), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell technology, announced that a new cohort of four patients will be added to its ongoing Phase 1 human clinical trial evaluating the safety and feasibility of using NSI-566 spinal cord-derived neural stem cells to repair chronic spinal cord injury (cSCI). The amended protocol was approved by the U.S. Food and Drug Administration and the Institutional Review Board at the study site, University of California San Diego (UCSD). NSI-566 is Neuralstems lead stem cell therapy candidate.

Under the amended protocol, updated on clinicaltrials.gov (NCT01772810), four qualifying patients with AIS-A complete, quadriplegic, cervical injuries involving C5-C7 cord will be added to the study. The injury must have occurred 1-2 years prior to the time of stem cell treatment, which is a one-time surgery involving six injections of NSI-566 into the affected area of the cord. The study has begun active recruitment of patients.

About 250,000 Americans are living with cSCI, and approximately 11,000 new injuries are reported each year1. Roughly 52% of these individuals will be considered paraplegic and 47% will be considered quadriplegic1. cSCI is a permanent and disabling condition with few to no treatments. Its devastating effect can be measured from social, healthcare, and economic perspectives.

This expansion of the study to cervical injuries builds on the results demonstrating that the implantation of NSI-566 stem cells in the first four patients with AIS-A complete thoracic cSCI was safe and feasible with no serious adverse events, said Karl Johe, Ph.D., Chief Scientific Officer, Neuralstem. There is a tremendous unmet need in the treatment of cSCI and we are privileged to have the experts at UCSD School of Medicine and the Sanford Stem Cell Clinical Center at UC San Diego Health conducting the research. We look forward to further evaluating NSI-566 neural stem cells in chronic complete cervical injuries."

Long-term safety data from the first cohort of chronic complete thoracic injuries is currently being analyzed by the study team at UCSD School of Medicine.

About Neuralstem Neuralstems patented technology enables the commercial-scale production of multiple types of central nervous system stem cells, which are being developed as potential therapies for multiple central nervous system diseases and conditions.

Neuralstems technology also enables the discovery of small molecule compounds by systematic screening chemical compounds against its proprietary human hippocampal stem cell line. The screening process has led to the discovery and patenting of molecules that Neuralstem believes may stimulate the brains capacity to generate new neurons, potentially reversing pathophysiologies associated with certain central nervous system (CNS) conditions.

The company has completed Phase 1a and 1b trials evaluating NSI-189, a novel neurogenic small molecule product candidate, for the treatment of major depressive disorder or MDD, and is currently conducting a Phase 2 efficacy study for MDD.

Neuralstems stem cell therapy product candidate, NSI-566, is a spinal cord-derived neural stem cell line. Neuralstem is currently evaluating NSI-566 in three indications: stroke, chronic spinal cord injury (cSCI), and Amyotrophic Lateral Sclerosis (ALS).

Neuralstem is conducting a Phase 1 safety study for the treatment of paralysis from chronic motor stroke at the BaYi Brain Hospital in Beijing, China. In addition, NSI-566 was evaluated in a Phase 1 safety study to treat paralysis due to chronic spinal cord injury as well as a Phase 1 and Phase 2a risk escalation, safety trials for ALS. Subjects from all three indications are currently in long-term observational follow-up periods to continue to monitor safety and possible therapeutic benefits.

Cautionary Statement Regarding Forward-Looking Information This news release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements relate to future, not past, events and may often be identified by words such as expect, anticipate, intend, plan, believe, seek or will. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Specific risks and uncertainties that could cause our actual results to differ materially from those expressed in our forward-looking statements include risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstems periodic reports, including the Annual Report on Form 10-K for the year ended December 31, 2015, and Form 10-Q for the nine months ended September 30, 2016, filed with the Securities and Exchange Commission (SEC), and in other reports filed with the SEC. We do not assume any obligation to update any forward-looking statements.

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1http://www.sci-info-pages.com/facts.html

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Neuralstem Expands Phase 1 Safety Trial of NSI-566 Neural Stem Cells in Spinal Injury - Yahoo Finance

Spinal Cord Stem Cells Comments Off on Neuralstem Expands Phase 1 Safety Trial of NSI-566 Neural Stem Cells in Spinal Injury – Yahoo Finance | April 14th, 2017

Germantown, Md.-based Neuralstem is involved in a Phase 1 human clinical trial testing the safety and feasibility of using NSI-566 spinal cord-derived neural stem cells to repair chronic spinal cord injury.

A biopharmaceutical company, Neuralstem develops nervous system therapies derived from neural stem cell technology.

Here are six takeaways:

1. NSI-566 represents the company's lead stem cell therapy candidate.

2. University of California San Diego serves as the study site, and just added a new cohort of four patients.

3. The four new patients all have AIS-A complete, quadriplegic, cervical injuries involving C5-C7 cord.

4. The patients suffered the injury one to two years before undergoing stem cell treatment.

5. The treatment involves six injections of NSI-566 into the spinal cord's affected area.

6. UCSD researchers are analyzing long-term safety data from the study's first cohort on chronic complete thoracic injuries.

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UC San Diego adds 4 patients to Neuralstem's neural stem cell study for spinal cord injury: 6 takeaways - Becker's Orthopedic & Spine

Spinal Cord Stem Cells Comments Off on UC San Diego adds 4 patients to Neuralstem’s neural stem cell study for spinal cord injury: 6 takeaways – Becker’s Orthopedic & Spine | April 14th, 2017

Alan Mackay-Sim, the 2017 Australian of the Year, told Tuesday's GE:Decoding Industry conference that too much university medical research languished for want of a different financing model.

Alan Mackay-Sim, the biomedical scientist who is 2017 Australian of the Year, has called for a new model of public-private partnership to fill the void left by major pharmaceutical companies withdrawing from neuroscience research.

Mr Mackay-Sim, a Griffith University researcher who led a team famed for proving the safety of using nasal cells to repair spinal cord damage, told a GE conference on Tuesday that all of the major pharmaceutical companies had closed or scaled back their neuroscience research units this decade because of the expense and risk in proving that drugs worked in the general population.

"Both Pfizer and Eli Lilly had treatments for Alzenheimer's Disease that failed at that finalstage of the [US Food & Drug Administration] approval process, and it had cost them each $US600million to getthere," he said.

With private enterprise less willing to solve complex neurological problems, Mr Mackay-Sim said it fell to "chumps like me" in the publicly-funded research sector.However, a fundamental mismatch between thebusiness model of universities and corporations had to be solved first.

"The problem is that for a university researcher today, the currency is to get your research published, that's how you get the next grant," he told the conference.

"But once it's published, it's no longer novel, it's not patentable and therefore private enterprise has no interest.Uni researchers are in it for the public good but unfortunately none of that good gets to the public without the commercial imperative."

Mr Mackay-Sim said universities could only afford to patent a fraction of the research they produced, and even then it too often languished for a lack of investors able to fund clinical trials. This happened to Mr Mackay-Sim's own 2001 patent for making stem cells from olfactory sheathing cells.

A new model was required which recognised the "value of future costs saved" in medical research and broadened the pool of potential financial backers, he told The Australian Financial Review on the sidelines of the GE conference.

"Our trial to prove that transplanting olfactory sheathing cells into the spinal cord was safe cost us $1 million, a second trial proving it works might costs us $20 million and the third trial to prove it works broadly might be $100 million or more - but we spend $2 billion a year in Australia caring for those with a spinal cord injury, so surely that's a good investment," Mr Mackay-Simsaid.

Insurance companies were a relatively untapped source of funding for medical research, he added, given their commercial interest in reducing the cost of medical care.

Patentable drugs had a hard enough time being commercialised, but it was even more difficult to fund trials for improved procedures.

"A friend of mine [University of WA Professor Sarah Dunlop] is trying to get up a clinical trial where people with spinal cord injuries are cooled as soon as the first responders get there, like what happens with heart attack patients," Mr Mackay-Sim said.

The slowing of the metabolism through cooling is thought to provide an opportunity for interventions that could increase the mobility of someone with a spinal cord injury.

"But it's a process, not a drug, it's not really patentable so it's proving a struggle to get funding despite this maybe meaning the difference between quadraplegiaand just having an arm immobilised."

The potential value of university-generated medical research couldbe recognised and supported by business earlier if a new kind of public-private partnership was supported and incentivised by government, spreading the risks and rewards, according to Mr Mackay-Sim.

"But it will take unis, government, investors, insurers, pharmaceutical companies and perhaps CSIRO coming together, to rethink this system where the patent and guarding all your IP is the model," he said.

Mr Mackay-Sim stressed he was "not a business guy", but said a benefit of being Australian of the Year was the access he was getting to people who could collaborate on a new funding model for medical research.

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Australian of the Year Alan Mackay-Sim calls for medical research funding change - The Australian Financial Review

Spinal Cord Stem Cells Comments Off on Australian of the Year Alan Mackay-Sim calls for medical research funding change – The Australian Financial Review | April 11th, 2017

Eight young Otago people have won awards in the 2017 New Zealand Youth Awards.

The awards recognise young New Zealanders who have achieved outstanding results and given back to their communities, as well as those who have made a significant contribution to the support of young people.

Kelly Young (20) and Jo Mohan (19), both of Dunedin, won a Change Maker Cultural Award for co-founding the University of Otago Students Without Borders Club, which helps refugees integrate into the Dunedin community.

Damon Lillis (21), of Dunedin, won a Working for Youth Award for his work on the board of the Playhouse Children's Theatre and has directed several plays which helps young people to increase their confidence and self-esteem.

He also co-ordinates the Aspire programme which helps young people from low decile schools find out more about University life.

Bokyong Mun (20), of Dunedin, also won a Working for Youth Award for her support and development of the United Nations Youth Council.

Fawzan Dinnunhan (24), of Dunedin, won a Giving Back Award for his contribution to research and improving a number of key IT platforms for the Spinal Cord Society - a non-profit organisation that studies the use of stem cells as a cure for type-1 diabetes.

Leo Munro-Heward (16), of Wanaka, also won a Giving Back Award for his establishment of the Queer Straight Alliance in Wanaka, which aims to raise awareness and support.

Holly Robinson (22), of Dunedin, won a Youth with Disability Award for representing New Zealand as the flag bearer in the opening ceremony for the Rio 2016 Paralympic Games.

She also broke the world record for the F46 javelin, and placed second overall.

Casey Davies-Bell (23), of Dunedin, won a Leadership Award for establishing Global Energy Impact Assessment (Geia) Ltd - a New Zealand based start-up company which aims to accelerate New Zealand's transition towards a sustainable future.

Youth Minister Nikki Kaye said about 190 nominations from around the country were received, and 50 were given awards at a ceremony in Parliament last night.

''The calibre of the award winners in the new Youth Enterprise category was outstanding, with the recipients including a number of under-20-year-olds who have founded successful businesses which have achieved significant social or business impact, both locally and internationally,'' she said.

''It's particularly encouraging to see the way these young leaders and entrepreneurs have embraced new technology and social media, to develop innovative new approaches to achieve their business or social vision.

''When you look at the drive, skills, compassion and integrity evident in the winners across all the categories, it's clear that our young people have enormous talent and potential, and the future of our country is in safe hands.''

john.lewis@odt.co.nz

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Eight from Otago receive NZ youth awards - Otago Daily Times

Spinal Cord Stem Cells Comments Off on Eight from Otago receive NZ youth awards – Otago Daily Times | April 11th, 2017

Suspended from a tree in the wilds of Tennessee, the remains of his hang-glider entangled in the branches above, his lower left leg pulverised and his chest badly bruised from his dramatic fall into the forest canopy, Alan Mackay-Sim felt hyper-alert from the electricity of adrenalin, the clarity of shock. Only the wind was audible, softly rustling the branches around him as he sucked in the forest air, perfumed with poplar and sweet-gum.

Knowing that the adrenalin coursing through his veins would soon give way to an agonising and possibly debilitating pain, the 28-year-old used these precious minutes to assess his predicament, to figure it out coolly like a man of science.

A broken leg, no doubt shattered in multiple places. Possibly hours before his fellow hang-gliding friends would be able to locate him; if they didn't reach him by nightfall, he could be dangling here until the next morning. Unfastening his harness and climbing down to the ground five metres below was not an option, at least, not without incurring further injury. To prevent blood from pooling and to save his leg, he quickly concluded, he'd have to carefully oh-so carefully free the hang-glider's stirrup bar and one of the ropes from his harness, create a splint for his injured left leg, secure it to his right leg and hoist up both limbs while hanging there like a gammy fruit bat.

Mackay-Sim had only arrived in the US a few weeks before, a post-doctoral researcher from the University of Sydney eager to extend his studies into the olfactory system specifically, what the nose tells the brain at the University of Philadelphia. But on that blustery October day back in 1979, when a freak wind gust whooshing around Lookout Mountain near Chattanooga sent a promising young Australian scientist nosediving into the forest, before a rescue team found himhanging in the tree just before sunset, both legs securely elevated, Mackay-Sim was set to gain some useful insights that would become valuable to him in his later life. Insights that would be peculiarly relevant to his work as a pioneering stem cell researcher specialising in the treatment of spinal cord injuries.

So badly broken was his leg that Mackay-Sim spent more than six months in a wheelchair, and many more months afterwards receiving intensive physiotherapy.

"It gave me some insight into what life's like in a wheelchair, and it stayed with me," says Mackay-Sim, settling into a chair in his office at the Institute for Drug Discovery at Griffith University, just down the corridor from the laboratory where he spent years toiling over petri dishes of nasal stem cells, in his life's mission to treat spinal injuries, hereditary spastic paraplegia and diseases like Parkinson's.

A photo of the late actor Christopher Reeve is pinned on a noticeboard behind him. "I met Christopher in 2003 when he came out for a conference; he was interested in our clinical trials," Mackay-Sim says, looking at the photo. "Then in the following year I spent some time at his home in New York, and we talked a lot about spinal cord injury repair, and his own personal story."

As Mackay-Sim explains, the higher up the spinal cord an injury is, the more severe the effects. "As we know, Christopher fell off a horse and became a full paraplegic on a respirator, but in fact he suffered only a small injury; the problem was that the bleed went straight into his spinal cord. It only takes a very small injury to stop transmission; you can have large injuries to the chest and not suffer long-term repercussions but here, in the neck, a small event can change your life."

Back in the late 1980s, after he started at Griffith University, Mackay-Sim became interested in a set of extraordinary busy-bee cells in the human nose called olfactory ensheathing cells nerve cells that regenerate every single day to recreate our sense of smell. If these wonder cells are continually regenerating, he kept asking himself, could they not be transplanted to another part of the body where cells don't regenerate, like the spinal cord?

Years of scientific slog followed until 2002, when Mackay-Sim was the first researcher in the world to remove cells from the nose of a patient paralysed in a car accident, grow them in a cell culture and then, with the help of surgeons at Brisbane's Princess Alexandra Hospital, implant them in the same patient's spinal cord. "By the time Christopher died in 2006, we'd transferred stem cells from the nose into three patients and shown it was safe to do so," he says. "One of the patients recovered some sensation above the injury, which was hopeful, but one person does not make real scientific evidence."

For Mackay-Sim, the importance of scientific breakthroughs in the treatment of life-threatening illnesses is deeply personal. In 2014, he was diagnosed with multiple myeloma, an incurable form of leukaemia. As a result of the illness, which breaks down bones in an advanced form of osteoporosis, and the punishing series of treatments that followed his diagnosis, involving radiation, chemotherapy and stem cell therapy (albeit a very different form from the one the scientist was researching), Mackay-Sim lost nine centimetres in height and shed more than 15 kilograms of body weight. "I became extremely sick from the chemotherapy just prior to the bone marrow transplant," the 65-year-old recalls. "It was the worst experience of my life."

There was also the initial shock of the diagnosis, and grief for the loss of his health after a highly active life, from football and rowing in his teens to distance cycling, scuba diving and hang-gliding, which he took up while atuniversity. "Both my parents lived into their 80s and 90s and I'd been cycling up to 200 kilometres a week for decades, so I wasn't anticipating something like this."

Still, as a scientist he couldn't help but observe the trajectory of his illness with stricken fascination. "I had some good conversations with my oncologist," he smiles. "As a biologist examining my own biology, it did demystify lots of things. One minute I was a grieving patient, the next an interested scientist."

Above all, Mackay-Sim refuses to sentimentalise his battle with the illness and asks that I don't embroider it in this story by turning it into some kind of triumph of personal will power over disease. "My survival is determined by the vagaries of the particular cancer I've got," he says matter-of-factly. "Some people have nasty genetic diseases that mean they die earlier. For the moment, I feel very healthy."

Surely his extreme fitness at least helped him to survive the ravages of chemo? "I think being fit and active all my life has given me a higher quality of life after treatment," he acknowledges. "But one doctor put it to me that I probably would have sought out treatment earlier if I wasn't so fit, because I dismissed the symptoms as simple back pain from the cycling. It took two years after the chemo and radiation for the pain to go away. 2016 was a year of normality for me my back became stable enough for me to get on a road bike again."

The diagnosis added poignancy to the evening in Canberra in late January when Mackay-Sim, out of 3000- plus nominations, was crowned Australian of the Year. Sitting alongside him were his American-born wife of nearly 34 years, Lisa Peine, a retired primary school teacher, their 28-year-old daughter Matilda, a trainee psychiatrist, and 25-year-old son Callum, an engineer.

Mackay-Sim with wife Lisa Peine in North Queensland in 1983. Photo: Courtesy of Alan Mackay-Sim

Perhaps no Australian of the Year is better placed to recognise just how precious a year can be, and more determined to seize the moment to put science and innovation at the top of the national conversation. A former Queenslander of the Year, Mackay-Sim sees science as vital to our future national wellbeing, especially after the recent wake-up call in international school education rankings, which placed Australia behind Kazakhstan and Slovenia in maths and science.

Mackay-Sim agrees unequivocally with Michelle Simmons, professor of quantum physics at the University of NSW, who drew headlines recently when she declared that the "feminised" nature of Australia's high school physics curriculum (emphasising the sociology of science with essays and theory instead of rigorous lab experiments and mathematical problem-solving) had been an unmitigated failure. Introduced in the 1980s, the approach had resulted in a long, slow decline in standards.

"Scientific understanding comes from learning the processes; it can be hard work but is absolutely essential," Mackay-Sim insists. "The key to a good science education in schools is to get well-trained teachers." (Mackay-Sim has been deeply encouraged by some of the science teachers he's met since winning the award.)

The choice of Mackay-Sim the first scientist honoured as Australian of the Year since immunologist Ian Frazer in 2006 was met with near-universal applause by Australia's scientific community, who no doubt feel dispirited in this post-truth world of climate-change denial, cuts to the CSIRO and the growing view by government agencies that basic research isn't worth it.

"We need to invest in young scientists," Mackay-Sim declared in his acceptance speech, adding that the discovery of new medical treatments can reduce the strain on health budgets. "More than 10,000 Australians live with a spinal cord injury a new person is added to this tally every day." But politicians need to take a long-term view of the benefits of basic research, he tells me, "a view much longer than the political horizon".

The announcement also gave the image of the Australian of the Year awards a much-needed polish. The 2016 winner, Lieutenant-General David Morrison, drew criticism for charging up to $15,000 a pop forpublic speaking engagements, as well as grandstanding about sexism in the military despite his own handling of the army's "Jedi Council" sex scandal, in which demeaning sex videos of women were distributed among a group of soldiers. (It was revealed that Morrison's office knew of the scandal 11 months prior to the former Chief of Army releasing a now-famous condemnation on YouTube of those involved.)

Will Mackay-Sim accept speakers' fees? "I knew nothing about speakers' fees when I accepted the award," he says crisply. "I'm not pursuing money after all, I've spent my life doing public research."

Although he hasn't received any fees to date, Mackay-Sim insists that if they are offered, the funds will be donated to the Hereditary Spastic Paraplegia Research Foundation, his charity of choice.

Mackay-Sim only had a day or so to bask in the glow of being named Australian of the Year before there was a claim his scientific achievements had beenoverstated in the application. A Polish scientist, Professor Pawel Tabakow, after being approached by an Australian journalist in Europe, declared that Mackay-Sim had nothing to do with the world-first surgery using olfactory stem cells that enabled a Polish paraplegic, Darek Fidyka, to walk again. "It is not our business who should be Australian of the Year," Tabakow told The Weekend Australian. "But it is our business when his work is being linked to the surgery of Fidyka. He has no link whatsoever."

The scientific hullaballoo arose from the submission to the Australia Day Council (ADC), which states that Mackay-Sim's research "helped play a central role in proving the safety of science that was a precursor to Dr Tabokow in Poland undertaking the first successful restoration of mobility in a quadriplegic man".

Although Mackay-Sim didn't write the submission to the ADC, doesn't know who did, and never claimed to be involved in Tabokow's work, an artificial straight line was drawn between the two scientists, especially when the word "precursor" was dropped from condensed versions of the ADC's quote in multiple news stories (we'll examine the fallout from the controversy a little later).

Padding amiably about his large, multi-room laboratory, past refrigerator-sized storage cabinets containing cell cultures, past white-coated scientists peering into microscopes, Mackay-Sim seems to be in his element, with every second person saying "Hi", "Hello", or "How are you?" If stem cells are indeedthe microscopic building blocks of the world, this is the tiny universe the scientist feels most comfortable in. But it's a laboratory that now has to hum along without him Mackay-Sim retired late last year, his duties now limited to popping into the university once a week as an emeritus professor.

Later in the day, Professor George D. Mellick, head of Clinical Neurosciences at Griffith, tells me that Mackay-Sim has always set aside time to mentor younger scientists, and to explain sometimes hideously complicated science to a lay audience, but would be the last person to crow about his own scientific achievements.

"One of the things that isn't highlighted very much about Alan's work is his research into Parkinson's. We've been able to learn a lot about Parkinson's by studying cells from people with the disease, and the information coming out of this research will hopefully lead to better treatments."

Back in his office, Mackay-Sim gives me a quick rundown, 101-style, on the human nose. No, the human sense of smell doesn't necessarily decline with age, unless illness or disease set in, and it is astonishingly adept at distinguishing hundreds of thousands of different odours. Yes, women do have a superior sense of smell to men, but the difference is surprisingly only slight. Yes, the first symptom of Parkinson's, before the typical tremors set in, is a reduced sense of smell, as it is with those sufferers who will go on to develop dementia. And yes paws down dogs do have a vastly more powerful sense of smell than humans, although it's impossible to quantify by exactly how much (Mackay-Sim has been known to hide from his spoodle Henry, to measure how long it takes for the dog to find him).

As he relays all this, Mackay-Sim's eyes twinkle and a smile lights up his face: it's easy to see how he'd be the perfect academic for Griffith to call on to schmooze a government minister or potential philanthropist and secure desperately sought-after funding. I ask him about his trademark moustache, which he's had since the early 1990s, when he shaved off a beard. "My wife wouldn't recognise me without it," he jokes. "She says that a small mammal could roost beneath my mouth."

Mackay-Sim, whose double-barrelled surname comes from his paternal grandfather, grew up in middle-class Roseville, on Sydney's leafy North Shore, the third of four brothers. His mother Lois was a nurse during World War II and later a full-time mum while his father Malcolm ran a hardware importing and distributing business, Macsim Distributors (now Macsim Fasteners, owned by Alan's eldest brother, Fraser). At North Sydney Boys' High he was "the opposite of a shit-stirrer. I was vice captain, head of the cadets, played football, was in the rowing team, had a shot at athletics, sang in the choir I did it all."

With wife, Lisa Peine, in Sulawesi, Indonesia, 2007. Photo: Courtesy of Alan Mackay-Sim

After graduating with honours in science from Macquarie University, Mackay-Sim picked up tutoring work in the department of physiology at the University of Sydney, where he completed a PhD on the brain's visual system. Two academic stints in the US followed, first at the University of Pennsylvania from 1979 until 1981, followed by two years at the University of Wyoming, during which time he met his wife Lisa, then living in northern Colorado.

The pair married in 1984, by which time Mackay-Sim had been offered a research role in the department of physiology at the University of Adelaide. He started at Griffith University in 1987, where his research concentrated on the biology of nasal cells.

At the height of the heated moral debate over the use of embryonic stem cells whether the therapeutic potential of stem cells could justify destroying human embryos to extract them Mackay-Sim met Pope Benedict XVI at a Vatican conference in 2005. The Pope congratulated him on his exclusive use of adult stem cells.

"I wasn't avoiding embryonic stem cells for religious reasons," Mackay-Sim explains. "It just so happenedthat I was working with adult stem cells at the time and the conference was looking at alternatives to using embryonic stem cells. But it was a scientific conference and I was impressed with its calibre; the only difference was that men in purple robes were sitting at the back asking questions."

Later in the same trip, Mackay-Sim was invited, along with a host of others, to the Apostolic Palace at Castel Gandolfo the Vatican summer palace. "You feel the history of the Roman Catholic Church, with the Pope coming in with his cardinals and the Swiss Guards," he says. "I'm not a believer, but it was a very powerful experience."

In 2006, the debate over embryonic stem cells virtually vanished when scientist Shinya Yamanaka from Japan's Kyoto University stunned the world by proving that stem cells needn't come from human embryos adult cells can be reprogrammed to act like stem cells, to be returned to an embryo-like state (Yamanaka's discovery won him the Nobel Prize in 2012). "Yamanaka worked out how to genetically engineer any cells so that they had the properties of embryonic stem cells," says Mackay-Sim, who nonetheless continued to focus on adult stem cells only.

Mackay-Sim accomplished his own world first in 2002 when, with the assistance of doctors at Brisbane's Princess Alexandra Hospital, he transplanted olfactory stem cells into the spinal cord of a man crippled in a car accident. The procedure was repeated with two other paraplegic patients at the same hospital and the study wrapped up in 2007.

While the procedures didn't result in any of the patients regaining useful movement in their legs, the results of Mackay-Sim's clinical trials, published in 2005 and 2008, paved the way for further development of olfactory stem cell transplantation.

One researcher who followed Mackay-Sim's trials closely was Geoffrey Raisman from University College London, who visited the Australian team shortly after the first operation in Brisbane to study their work. Raisman later led the British team who worked with Polish surgeon Tabakow on Darek Fidyka in 2012.

Tabakow deployed 100 separate micro-injections of olfactory sheathing cells above and below Fidyka's spinal injury, with the hope these cells would provide a skeleton for nerve fibres to grow and reconnect. A former volunteer firefighter, Fidyka had become paralysed in 2010 after a severe knife attack by the jealous ex-husband of his girlfriend. The repeated stab wounds to Fidyka's back severed his spinal cord, paralysing from the waistdown. (Fidyka's attacker, a fellow firefighter, committed suicide shortly afterwards.)

There's no doubt Tabakow's work was a major advance on Mackay-Sim's research. Tabakow's strategy was to extract ensheathing cells specifically from the olfactory bulbs in Fidyka's nose, grow them in a culture, while also extracting nerve cells from his ankle in a multi-pronged attempt at spinal cord reconstruction. After a series of operations, Fidyka can walk with the assistance of a frame, has regained some bladder control and sexual function, and can ride a tricycle.

Raisman described their new stem cell procedure as "more impressive than man walking on the moon", but it will have be tested on other paraplegics, including those with more severe injuries than Fidyka's, such as car accident victims who have had more of their spinal cord damaged, before it can be declared a reliable method of restoring mobility. As impressive as Tabakow's achievement is, it has still only worked on one patient.

Nobody, however, disputes Mackay-Sim's immense contribution to stem cell transplantation; his work is unimpeachable. If nothing else, he was at the forefront of the science showing that restoring the ability to walk to paraplegics is no longer science fiction. "What I've always said is that we did the first phase of clinicaltrials with olfactory stem cells, and the aim of those trials was to show they were safe," says Mackay-Sim. "That was the first important step."

Mackay-Sim wrote to Tabakow shortly after the controversy blew up, explaining that he didn't write the submission to the Australia Day Council, and was in no way claiming credit for Fidyka's remarkable recovery. "He wrote back a very nice email," says Mackay-Sim. "I believe I've given credit to other scientists in every interview I've given to journalists. I feel comfortable in my behaviour and ethics."

With Prime Minister Turnbull in January this year. Photo: Elesa Kurtz

Mackay-Sim can remember the day when he felt something was wrong terribly wrong. He'd been suffering back pain for months, but dismissed it as old age, or strain from bending over on his bicycle on long rides, and stocked up his pantry with painkillers. "I was in Colorado with Lisa visiting her family, and the pain became so bad I couldn't walk very far. I found the pain eased when I got on my bicycle. I flew home a week before she did; the plane trip back was absolute hell."

What followed was a swift diagnostic journey from his GP to specialists at Brisbane's Wesley Hospital, resulting in a devastating diagnosis. "They suspected something cancerous quite quickly. I didn't realise how ill I was; by this stage, my kidneys weren't coping at all with the antibodies released from my white blood cells, which were going berserk trying to fight the disease. I was at risk of kidney failure and my bones were becoming very fragile. I started therapy almost immediately, in June 2014. Then began the cycles of chemotherapy and stem cell treatment in December."

Since the beginning of last year, however, Mackay-Sim's health has dramatically improved, and even though he's retired to his beachside home in Currimundi on the Sunshine Coast, he is still active in university affairs. He concedes that his health may prevent him from being as active as Rosie Batty, perhaps our most vigorous Australian of the Year to date. But he's already spoken at functions in Brisbane, Sydney and Perth, and will be attending the national March for Science on April 22, which coincides with Earth Day. He moves with the speed and fluidity of a man 10 or 15 years younger.

"I feel very healthy, very energised at the moment," says Mackay-Sim, who is planning a bicycle ride in Italy's Dolomites in July with a couple of mates. (Last year he and his wife went on the Great Victorian Bike Ride, a seven-day ride averaging 85 kilometres a day.)

"I do need to be selective with the number of invitations around Australian of the Year," he concedes, "but I'll do everything I can. After all, what more exciting time could you have to talk about science?"

Original post:
Australian of the Year Alan Mackay-Sim on the advantage of being 'an interested scientist' - The Sydney Morning Herald

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