Malia

March is Multiple Sclerosis Month and Hadassah leads the world in the stunning success and implementation of the research at Hadassah Hospital in Jerusalem. Malia is just one of the many stories of triumph in Prof. Dimitrios Karussis program.

Malia was a top Dallas trial attorney-a senior partner in a law firm and the mother of three children, the youngest, age five. Her energy level was high and her life was full. And then, 18 years ago, she was diagnosed with multiple sclerosis (MS).

In the beginning, her symptoms were mild. For example, she was a little unsteady in her walking. She began taking a weekly injection of Avonex because, as her doctor told her, "You wouldn't want me to treat you for high blood pressure only after you had a heart attack."

Malia took Avonex for about 10 years. Still, her life became a journey of declining energy and mobility. Her biggest fear was that she would lose her vision and not be able to drive her children around. Fortunately, she didn't experience any problems with her vision, but her gait did get worse, as did the fatigue.

Ultimately, she could only walk a very short distance with a walker. Her balance became more unsteady. Her speech was harder to understand. And the fatigue got so bad that even taking a shower was so exhausting that she needed a nap afterward.

Malia tried four or five different medicines, but none seemed to help. As she explained, however, the promise of these medicines is only to slow the progression of the disease, not to improve upon one's symptoms.

At one point on this odyssey of decline, Malia fell and broke her leg and found herself in a wheelchair for six weeks. She began to research other treatment options, surfing the Internet extensively. It was how she came upon the innovative stem-cell work of Prof. Dimitrios Karussis, senior neurologist at Hadassah Hospital Ein Kerem and head of its Multiple Sclerosis Center. She learned that Prof. Karussis was conducting a unique MS clinical trial involving the injection of a patient's own bone marrow-derived stem cells directly into the spinal cord.

When she met Prof. Karussis for the first time, she was walking with a walker, but couldn't walk any real distance. It was December 2014. In the spring of 2015, Malia, who was accepted into one of Prof. Karussis' clinical trials, traveled back to Hadassah to have a bone marrow extraction, which would be the basis for her stem-cell transplant. As she explains, just a syringe of cells is extracted, but then these cells are enhanced in culture for six months. In the fall of 2016, Malia received her first infusion. The actual infusion, itself, Malia relates, took only five minutes!

"I got the infusion at 2 p.m.," Malia recalled, "and eight hours later, I did something I had not done in two to three years." She explained that before the infusion, whenever she got out of bed, to get back in, she would have to lift her right leg with her hands. This time, post infusion, after she got up to go to the bathroom, she was able to get back into bed by just lifting her right leg onto the bedwithout holding it! She called the kids; her husband, David, made a video of her new ability. When her doctors came in that next morning to see how she was doing, she showed them her new skill. "Everyone was sobbing," she recalled; "we were all so excited by how amazing it was."

Malia said: "The most important thing of all was that the level of my fatigue was so improved."

Taking herself back to the night she returned home from that first infusion, Malia recalled: "We arrived back home at midnight. The next morning at 8, I was up writing my blog. Then I unpacked, did laundry, and made a five-course dinner for my husband, after which he went to bed, exhausted from the jet lag. I, however, stayed up to crochet a new blanket until midnight."

That renewed energy has never disappeared since Malia started getting stem-cell infusions at Hadassah. She received two more in 2016 and the most recent in February 2017. The kind of improvements varied with each infusion-sometimes the improvement in her gait was most noticeable; other times, it was the clarity of her speech. With the 2017 infusion, it was her balance. A year or so ago, she could only balance herself on a "whole body vibration machine" for about a minute and a half. Then she worked this up to five minutes. After this fourth infusion, she could stay on the machine for 12 minutes and even let go of the bar with one hand.

In addition, before every infusion, a baseline measurement of her abilities is taken. The most recent baseline, Malia reported, was higher than ever before. By the same token, her overall physical improvements are the best they've been.

Malia's recovery is not without its setbacks. As the stem-cell treatment wears off, she does experience some backsliding in her improvements-perhaps in her speech or the way she walks. Nevertheless, after she has a treatment, the improvements return or surpass the previous ones.

"I had forgotten what it was like to feel like a regular person, like someone with a normal level of energy; I had forgotten what it was like to feel good," Malia said.

When she is out and about with her walker, she sees people looking at her with sympathy. But she doesn't feel sorry for herself, she notes, because she has gotten her life back. Malia feels blessed that she has come this far. "Until you've been there, you can't really understand just how important it is to feel like a regular person."

Malia had stopped practicing law when she was diagnosed with MS. But just recently she reactivated her law license. She took on a case, with a colleague. And in the beginning of April, she will be going to trial.

"When you feel like you can do things you used to do, life is as it should be," Malia said.

Malia no longer takes any medication for MS and being an MS patient is no longer a central focus of her life. But, she is now a stem-cell activist and fundraiser on behalf of Hadassah because "I feel I have been given a gift and I want to ensure that more people with MS can be helped."

While she doesn't know the other participants in the clinical trial, she did meet one man from London last time she was at the hospital for her infusion. As she relates, this man was "giddy with excitement, lifting his cane in the air with one hand." They began to talk and he explained that he just had his first stem-cell infusion and, overnight, he was able to lift his cane up in the air with his right hand when for 15 years he had been unable to even hold anything in that hand.

"What I would like Hadassah supporters around the world to understand," Malia related, "is that yes, I get the wonderful benefits of Prof. Karussis' stem-cell treatments (and, of course, she does not minimize his trailblazing hard work and miraculous success), "but I also was surprised to learn that I have this large Hadassah cheering squad that gives me hope and supports me-making me believe in possibilities for improvement. As Malia recalled, when she sits with a visitor from Hadassah and sees the look of awe on the face of this Hadassah supporter because of the leap in her improvement, it gives her renewed strength. "There are many things I want to do with the rest of my life," Malia said, "and raising money for Hadassah is at the top of the list."

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Hadassah is winning the battle with MS - Heritage Florida Jewish News

Spinal Cord Stem Cells Comments Off on Hadassah is winning the battle with MS – Heritage Florida Jewish News | March 24th, 2017

A small stem cell trial in which patients with severe spinal injuriesappeared to make remarkable progress is still showing excellent results, according to the company conductingthe research.

One of the patients in the trial is 21-year-old Kris Boesen, from Bakersfield, California, whose story we reported on last year.A car crash had left theBakersfield, California native with three crushed vertebrae, almost no feeling below his neck, and a grimprognosis. Doctors believed he would live the rest of his life as a paraplegic.

Enter stem cell therapy. Most treatments for serious spinal injuries concentrate on physical therapy to expand the range of the patients remainingmotor skills and to limit further injury, not to reverse the actual damage. But last April, as part of an experimental phase 2 clinical trial called SCiStar, researchers injected Boesen with 10 million stem cells. By July, hehad recovered use of his hands to the point where he could use a wheelchair, a computer and a cellphone, and could take care of most of his daily living needs.In recent months his progress has continued, says his father.

Boesen is not the only patient to have improved in the trial, according toAsterias Biotherapeutics, which is conducting the research. Boesen is part of a cohort of six patients who were experiencing various levels of paralysis and were injected with the 10 million stem cell dose. In a Jan. 24update, the company saidfive of those patientshad improved either one or twolevels on a widely used scale to measuremotor function in spinal injury patients.

On Tuesday, Asterias issued a newupdate, announcingthat the sixth patient in the cohort has experienced a similar improvement.

While spontaneous recovery for spinal injury patients does occur,the likelihood of all six patients recovering to the degree they haveis less likely, researchers say.

This is as good as you could hope at this point, said Charles Liu, Boesens neurosurgeon and director of the USC Neurorestoration Center. So far all the evidence is pointing in the right direction.

To measure improvement in spinal injury patients, researchers use two yardsticks: the Upper Extremity Motor Scale, or UEMS, and the International Standards for Neurological Classification of Spinal Cord Injury, or ISNCSCI. On the UEMS scale,patients are scored from 0 to 5 on theirability to use five key muscles in the wrists, elbows and fingers. The ISNCSCI scale assesses where damage has occurred along the different levels of the cervical vertebrae, which generally determines the scope of impairment to the body and the level of care needed.

For instance, if a patient has sustained damage at the fourth cervical vertebra down, known as C-4, at the base of the neck, it generally means that person is paralyzed from the neck down, requiring round-the-clock care and a ventilator to breathe.A patient with a C-5 injury may not be able to move her arms or hands, requiring about 6 to 12 hours per day of assisted care; and at the C-6 level, better motor function mayallow a patient to take care of most of herdaily living needs on her own.

Which is all to say that even one level of recovery could substantially improve the daily life ofa spinal injury patient.

According to Asterias, all six patients in the 10million-cell cohort have improved their general UEMS scores, and jumped at least one motor level on the ISNCSCI scale on one or both sides of their body.

Two patients have improvedtwo motor levels on one side; and one patient,Boesen, has improved two motor levels on both sides.

Steve Cartt, president and CEO of Asterias, said anotherpatient, Jake Javier of Danville, California, has gonefrom partial paralysis to being able to use his hands well enough to considerpursuing a computer science career.

Throws Like a Regular Throw

In September, Boesens father, Rod Boesen, told us how excited he wasthat his son had regained some feeling in one of his feet. Last week, at11 months post-injection, the elder Boesensaid Kris has continued to improve.

Now he can move his toe and his knee together at the same time, Boesen said. Theyre about to give him a manual wheelchair now [instead of a motorized one]. He can grip with his hands enough to use a manual one.

Boesen said the movement in his sons arms and hands has greatlyimproved since September.Kris, a formerhigh school pitcher, had beenflinging a ball to his dog like people throw hand grenades, Boesen said. They kind of cradle them and thats how Kris would do it. But now he throws like a regular throw, tosses that ball down the hall, has that release point down, and just wings it.

Asterias is currently recruiting patients for a trial in which theyll receive 20 million stem cells, the optimal dose, according to company researchers. Two patients have already started the 20 million stem cell therapy, and six-month results from those patients will be released in the fall, Cartt said.

Patients who received 2 million stem cells in an earlier phase of the study have not shown much change in their condition, according to the Jan. 24 update.

Guarded Optimism

While Boesens father is impressed with the results, the optimism of researchers inside and outside the studyhas been guarded.The trial is still in its early stages, and the sample size is small, said Paul Knoepfler, a cell biology professor and stem cell researcher at UC Davis, who is not involved in the SCiStar study.

As a scientist, I still would want to wait for more data, Knoepfler said. Its certainly interesting, but its still early. Its a phase 2 trial.

To address the issue of small sample size, Asterias islooking at historical data to determinethe level of improvement for patients in similar circumstances who did not receive stem cell therapy. The company has said it found a meaningful difference in the recovery of its study patients compared to the norm.

Liu said one of the most importantresults is the lack of significant side effects or other negative outcomes resulting from the treatment to date.

Thats very significant to me, Liu said. Thats the first thing you look for, is anyone hurt from this therapy.

There was also a concern, he said, that some patients might regress over time, once the initial injection of stem cells wore off. Thathasyet to occur.

No one has lost anything theyve gained, Liu said. We were very happy to see that. This is all very promising.

The next step for the SCiStartrial will be to establish a control group, Cartt said.

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Strong Progress for Paralyzed Patients After Stem Cell Therapy, Company Says - KQED

Spinal Cord Stem Cells Comments Off on Strong Progress for Paralyzed Patients After Stem Cell Therapy, Company Says – KQED | March 23rd, 2017

For a soldier who suffered a spinal cord injury on the battlefield, the promise of regenerative medicine is to fully repair the resulting limb paralysis. But that hope is still years from reality.

Not only powerful, but efficient. Studying diseases in lab-created tissue may help reduce the price tag now roughly $1.8 billion for bringing a new drug to market, which is one of the reasons Ashton received a National Science Foundation CAREER Award for advancing tissue engineering of the human spinal cord. During the projects five-year funding period, his lab in the Wisconsin Institute for Discovery will fine-tune the technology for growing a neural tube, the developmental predecessor of the spinal cord, from scratch.

As the neural tube matures and diversifies during the development of a human embryo, it gives rise to the two core parts of our central nervous system: the brain and spinal cord. By replicating this process in a dish, Ashton hopes to develop a platform for research that is highly reproducible and can be broadly disseminated. Biologists could simply add their cells to Ashtons starter tissue to build a model of whichever spinal cord disease they desire.

By starting with cells from an individual patient, researchers will be able to target disease therapies to a particular genetic background a concept known as personalized medicine. Drug tests in engineered spinal cords may become an intermediate step between animal models and clinical trials of patients affected by Lou Gehrigs disease, multiple sclerosis or spinal cord injuries, helping to bridge the differences between a human and rodent spinal cord.

Weve cured spinal cord diseases in a lot of rodents over the years, but only a small percentage of those drugs work in humans, Ashton says. If we can make the engineered tissue as close as possible to whats in our body, this will eventually translate to better drugs.

The recipe Ashton and fellow UWMadison engineering professors Lih-Sheng (Tom) Turng and David Beebe plan to follow to coax stem cells into forming a neural tube goes something like this: First, they use water-soluble Lego-type molds to create microscale cavities within a jelly-like substance. Then they add human neural stem cells into these cavities, and let the cells coalesce as they do naturally to form neural tube-resembling tissue.

Next, they add signaling molecules whose variable concentration instructs the stem cells to turn into different types of neurons and neuron-supporting cells. Last comes the greatest challenge: getting these specialized cells to connect to one another and form electric circuits that give the spinal cord its function.

The complexity of the central nervous system exists because specific circuits have to form over very long distances. If any part of a circuit goes awry, you lose function, Ashton explains. The biggest open question is whether the tissue we create in vitro will have the proper wiring of different cell types to yield circuits similar to those in our body.

Ashtons CAREER Award will also fund educational activities that range from expanding outreach programs for underrepresented minority K-12 students, to creating a website and exhibit for the public, to educating Madison-area high school teachers about tissue engineering.

Ashton, who is African-American, comes from a socially active family background his grandfather was a minister and president of the Virginia chapter of the NAACP. He has assisted the nonprofit group 100 Black Men of Madison with its K-12 mentoring programs for years.

He plans to use the new grant to develop virtual interactive lab experiments and matching teaching modules.

I hope to attract more students to the fast-growing field of regenerative medicine, Ashton says, and to motivate people to continue to fund this kind of research so that we can develop therapies to cure diseases, instead of just treating their symptoms.

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

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Growing a Neural Tube in a Dish | Technology Networks - Technology Networks

Spinal Cord Stem Cells Comments Off on Growing a Neural Tube in a Dish | Technology Networks – Technology Networks | March 22nd, 2017

Men's Fitness

Want more stem cells and a higher pain tolerance? Try shocking yourself. Men's Fitness The acupuncture stimulus we're giving these animals has a rapid effect on neuroanatomical pathways that connect the stimulus point in the arm to responsive neurons in the spinal cord and into a region in the brain called the hypothalamus. In turn, the ...

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Want more stem cells and a higher pain tolerance? Try shocking yourself. - Men's Fitness

Spinal Cord Stem Cells Comments Off on Want more stem cells and a higher pain tolerance? Try shocking yourself. – Men’s Fitness | March 22nd, 2017

Spinal Cord Injury Treatment Status and Improvements after Treatment

Till the end of 2014, our department has treated 3166 patients with sequela of spinal cord injury, including 1452 patients with cervical cord injury, 1193 patients with thoracic cord injury (do not include T12-L1), 216 patients with both cervical cord and thoracic cord injury, and 305 patients with thoracic and lumbar cord injury (mainly T12-L1). We invented CT-guided intraspinal injection in 2006 and stem cell transplantation via endovascular intervention in 2011 to treat sequela of spinal cord injury, which apparently improved the treatment effect. Since 2011, the improvement rate of patients with sequela of spinal cord injury has reached 96%......Read More >>

Spinal Cord Injury Cases

Name: Qanat Age: 32 Diagnosis: old spinal cord injury Nationality: kazakhstan The patient got spinal cord injury of T6 in a car accident in November 2006. He came to our department three times for 3 cycles of stem cells transplantation treatment in June 2009, March 2010, and April 2011.

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Spinal Cord Injury

Spinal cord injury -- caused by direct/indirect external factors, there could be dyskinesia, sensory and sphincter dysfunction, dystonia and pathologic reflex at the injured segments. The injury level and clinical feature lie on the position and property of the primary injury.

Spinal Cord InjurySymptoms

Different injury segments have different symptoms and signs, we can distinguish the segment of injured spine from the injury features: 1. Upper cervical spinal ( C1-4 ) 2. Lower cervical spinal ( C5-8 ) injury 3. Thoracic spine ( T1-12 ) injury 4. Intumescentia lumbar ( L1-S2 ) injury 5. Conus medullaries ( S3-5 ) injury 6. Cauda equnia injury Read MoreSpinal Cord Injury Symptoms >>

AboutUs

The Stem Cell Department of General Hospital of Chinese Peoples Armed Police Forces andthe 309th Hospital of Chinese People's Liberation Army is the first neural stem cell transplantation center at home and abroad, which went through WHO clinical trial registration, obtained the FDA clinical trial approval and had laboratory with GMP certification of stem cell research and preparation. Leaders in stem cell treatments for cerebral palsy, spinal cord injury, traumatic brain injury syndrome, ulcerative colitis, cirrhosis, stroke, diabetes and multiple system atrophy.Till now, we have used stem cell therapy to treat about 10,000+ patients from more than 30 countries. More About Us >>

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Spinal Cord Injury (SCI) - Stem Cell Therapy China

Spinal Cord Stem Cells Comments Off on Spinal Cord Injury (SCI) – Stem Cell Therapy China | March 22nd, 2017

BUFFALO, N.Y. A discovery, several years in the making, by a University at Buffalo research team has proven that adult skin cells can be converted into neural crest cells (a type of stem cell) without any genetic modification, and that these stem cells can yield other cells that are present in the spinal cord and the brain.

The applications could be very significant, from studying genetic diseases in a dish to generating possible regenerative cures from the patients own cells.

Its actually quite remarkable that it happens, says Stelios T. Andreadis, PhD, professor and chair of UBs Department of Chemical and Biological Engineering, who recently published a paper on the results in the journal Stem Cells.

The identity of the cells was further confirmed by lineage tracing experiments, where the reprogrammed cells were implanted in chicken embryos and acted just as neural crest cells do.

Stem cells have been derived from adult cells before, but not without adding genes to alter the cells. The new process yields neural crest cells without addition of foreign genetic material. The reprogrammed neural crest cells can become smooth muscle cells, melanocytes, Schwann cells or neurons.

In medical applications this has tremendous potential because you can always get a skin biopsy, Andreadis says. We can grow the cells to large numbers and reprogram them, without genetic modification. So, autologous cells derived from the patient can be used to treat devastating neurogenic diseases that are currently hampered by the lack of easily accessible cell sources.

The process can also be used to model disease. Skin cells from a person with a genetic disease of the nervous system can be reprogrammed into neural crest cells. These cells will have the disease-causing mutation in their chromosomes, but the genes that cause the mutation are not expressed in the skin. The genes are likely to be expressed when cells differentiate into neural crest lineages, such as neurons or Schwann cells, thereby enabling researchers to study the disease in a dish. This is similar to induced pluripotent stem cells, but without genetic modification or reprograming to the pluripotent state.

The discovery was a gradual process, Andreadis says, as successive experiments kept leading to something new. It was one step at a time. It was a very challenging task that took almost five years and involved a wide range of expertise and collaborators to bring it to fruition, Andreadis says. Collaborators include Gabriella Popescu, PhD, professor in the Department of Biochemistry in the Jacobs School of Medicine and Biomedical Sciences at UB; Song Liu, PhD, vice chair of biostatistics and bioinformatics at Roswell Park Cancer Institute and a research associate professor in biostatistics UBs School of Public Health and Health Professions; and Marianne Bronner, PhD, professor of biology and biological engineering, California Institute of Technology.

Andreadis credits the persistence of his then-PhD student, Vivek K. Bajpai, for sticking with it.

He is an excellent and persistent student, Andreadis says. Most students would have given up. Andreadis also credits a seed grant from UBs office of the Vice President for Research and Economic Developments IMPACT program that enabled part of the work.

The work recently received a $1.7 million National Institutes of Health grant to delve into the mechanisms that occur as the cells reprogram, and to employ the cells for treating the Parkinsons-like symptoms in a mouse model of hypomyelinating disease.

This work has the potential to provide a novel source of abundant, easily accessible and autologous cells for treatment of devastating neurodegenerative diseases. We are excited about this discovery and its potential impact and are grateful to NIH for the opportunity to pursue it further, Andreadis said.

The research, described in the journal Stem Cells under the title Reprogramming Postnatal Human Epidermal Keratinocytes Toward Functional Neural Crest Fates, was supported by grants from the National Institutes of Health.

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From skin to brain: Stem cells without genetic modification - UB News Center

Spinal Cord Stem Cells Comments Off on From skin to brain: Stem cells without genetic modification – UB News Center | March 22nd, 2017

Spinal cord injuries are among the most dramatic and devastating of all injuries, in part because they stem from traumatic accidents but also because there are very few treatment options.

While medical advances have been made in the areas of injury management and improved long-term functioning, for those dealing with spinal cord injuries the sad truth is that researchers have yet to come up with a cure for paralysis.

Victims of spinal cord injuries are left facing a lifelong disability, one that comes not only with a range of personal burdens but which also extracts its toll on the healthcare system studies have shown that the lifetime economic burden of spinal cord injuries in Canada ranges between $1.5 to $3.0 million per individual.

Yet cell therapies represent one area of current research that appears likely to deliver positive results. According to a new study from researchers with the University Health Network and the University of Toronto, the neuroregenerative potential of this approach is promising.

Cell therapy, which in general refers to any procedure involving the implantation of cells, comes in different guises in spinal cord research, depending on the type of cells employed. Clinical research is already being performed using stem cells, which have the ability to self-renew and to differentiate into a variety of specialized cells, and glial cells, which support neural functioning.

The aim in both cases is to introduce the new cells so as to encourage regrowth of nerve fibres where they have been severed and thereby restore nerve function, a seemingly impossible task, since along with the structural damage caused by spinal cord injury comes a series of secondary events such as scarring and inflammation which, although normal bodily repair processes, can effectively impede the chances at regrowth and reconnection of neural networks.

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Reviewing the current state of affairs in spinal cord research, the researchers find that cell therapies, especially those that combine more than one approach, are showing promise but need further study and clinical trials. While combinatorial treatments using cell-coupling, trophic factors, biomaterials, and rehabilitation, may help to improve stem cell effectiveness among a heterogeneous patient population, there is still much research required to optimize their application, say the studys authors.

The researchers found that in early clinical trials, for example, cell therapies have shown modest improvements connected to functional recovery, yet they say that the results are encouraging and that even slight enhancements in sensation and function for those dealing with spinal cord injuries are often quite meaningful. It is clear that a lot remains to be understood in the translation of stem cell therapies, say the studys authors. However, given the significant strides in laboratory work, we should not lose sight of their potential.

The new research is published in the journal Expert Opinion on Biological Therapy.

The primary causes of spinal cord injuries are motor vehicle accidents and unintentional falls, each accounting for a little over 40 per cent of spinal cord injuries. According to Spinal Cord Injury Ontario, there are 1,500 new spinal cord injuries each year and a total of 86,000 Canadians currently living with spinal cord injuries.

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Stem cell therapy shows promise in treating spinal cord injuries ... - Cantech Letter

Spinal Cord Stem Cells Comments Off on Stem cell therapy shows promise in treating spinal cord injuries … – Cantech Letter | March 22nd, 2017

By Staff

Electroacupuncture triggers a neurological response that releases stem cells that can relieve injury-induced pain, and help promote tissue repair, says a study in the journal Stem Cells led by Indiana University School of Medicine.

The school outlined its findings in a media release:

Electroacupuncture is a form of acupuncture that uses a small electrical current to augment the ancient Chinese medical practice of inserting fine needles into the skin at pre-determined points throughout the body.

For the study, a team of more than 40 scientists at institutions in the United States and South Korea was led by four senior authors including IU School of Medicines Maria B. Grant, MD, Marilyn Glick Professor of Ophthalmology and co-corresponding author; Mervin C. Yoder, MD, IU Distinguished Professor, Richard and Pauline Klingler Professor of Pediatrics, associate dean for entrepreneurial research at IU School of Medicine, director of the Herman B Wells Center for Pediatric Research and co-corresponding author; and Fletcher A. White, PhD, Vergil K. Stoelting Chair ofAnesthesia, professor of anesthesia, pharmacology and toxicology.

This work is a classic example of the power of team science, where investigators in different institutions with specific expertise worked together to unravel the complexity of how electroacupuncture works to help the body respond to stressors, said Dr. Yoder.

The researchers performed a series of lab tests involving humans, horses and rodents that follow the effects of electroacupuncture from the stimulus of the needle all the way to the brain, resulting in the release of reparative mesenchymal stem cells (MSCs) into the bloodstream.

Depending on the species, electroacupuncture led to activation of the hypothalamusa part of the brain that controls the nervous system and involuntary bodily functions such as heart rate and digestionwithin nine to 22 minutes. The stem cells were mobilized within two hours.

The acupuncture stimulus were giving these animals has a rapid effect on neuroanatomical pathways that connect the stimulus point in the arm to responsive neurons in the spinal cord and into a region in the brain called the hypothalamus. In turn, the hypothalamus directs outgoing signals to stem cell niches resulting in their release, said Dr. White, who is a neuroscientist at the Richard L. Roudebush VA Medical Center in Indianapolis.

The researchers found electroacupuncture treatments resulted in higher thresholds for injury-induced pain, as well as considerable increases in the presence of a type of collagen that promotes tendon repair and anti-inflammatory cells known to be predictors of faster healing time.

Dr. White said these findings could lead to new strategies for tissue repair and pain management related to injuries.

We could potentially capture the MSCs from an individuals blood following electroacupuncture and save the cells for future re-introduction in the patient post-surgery or to treat chronic pain due to an injury, he said.

The horses used in the study had been injured during training for international dressage competitions, and the six people who took part were healthy volunteers, who still showed activation of their hypothalamus through brain imaging.

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Electroacupuncture Releases Stem Cells to Relieve Pain and More, Study Finds - National Pain Report

Spinal Cord Stem Cells Comments Off on Electroacupuncture Releases Stem Cells to Relieve Pain and More, Study Finds – National Pain Report | March 20th, 2017

A discovery, several years in the making, by a University at Buffalo research team has proven that adult skin cells can be converted into neural crest cells (a type of stem cell) without any genetic modification, and that these stem cells can yield other cells that are present in the spinal cord and the brain.

The applications could be very significant, from studying genetic diseases in a dish to generating possible regenerative cures from the patients own cells.

Its actually quite remarkable that it happens, says Stelios T. Andreadis, PhD, professor and chair of UBs Department of Chemical and Biological Engineering, who recently published a paper on the results in the journal Stem Cells.

The identity of the cells was further confirmed by lineage tracing experiments, where the reprogrammed cells were implanted in chicken embryos and acted just as neural crest cells do.

Stem cells have been derived from adult cells before, but not without adding genes to alter the cells. The new process yields neural crest cells without addition of foreign genetic material. The reprogrammed neural crest cells can become smooth muscle cells, melanocytes, Schwann cells or neurons.

In medical applications this has tremendous potential because you can always get a skin biopsy, Andreadis says. We can grow the cells to large numbers and reprogram them, without genetic modification. So, autologous cells derived from the patient can be used to treat devastating neurogenic diseases that are currently hampered by the lack of easily accessible cell sources.

The process can also be used to model disease. Skin cells from a person with a genetic disease of the nervous system can be reprogrammed into neural crest cells. These cells will have the disease-causing mutation in their chromosomes, but the genes that cause the mutation are not expressed in the skin. The genes are likely to be expressed when cells differentiate into neural crest lineages, such as neurons or Schwann cells, thereby enabling researchers to study the disease in a dish. This is similar to induced pluripotent stem cells, but without genetic modification or reprograming to the pluripotent state.

The discovery was a gradual process, Andreadis says, as successive experiments kept leading to something new. It was one step at a time. It was a very challenging task that took almost five years and involved a wide range of expertise and collaborators to bring it to fruition, Andreadis says. Collaborators include Gabriella Popescu, PhD, professor in the Department of Biochemistry in the Jacobs School of Medicine and Biomedical Sciences at UB; Song Liu, PhD, vice chair of biostatistics and bioinformatics at Roswell Park Cancer Institute and a research associate professor in biostatistics UBs School of Public Health and Health Professions; and Marianne Bronner, PhD, professor of biology and biological engineering, California Institute of Technology.

Andreadis credits the persistence of his then-PhD student, Vivek K. Bajpai, for sticking with it.

He is an excellent and persistent student, Andreadis says. Most students would have given up. Andreadis also credits a seed grant from UBs office of the Vice President for Research and Economic Developments IMPACT program that enabled part of the work.

The work recently received a $1.7 million National Institutes of Health grant to delve into the mechanisms that occur as the cells reprogram, and to employ the cells for treating the Parkinsons-like symptoms in a mouse model of hypomyelinating disease.

This work has the potential to provide a novel source of abundant, easily accessible and autologous cells for treatment of devastating neurodegenerative diseases. We are excited about this discovery and its potential impact and are grateful to NIH for the opportunity to pursue it further, Andreadis said.

The research, described in the journal Stem Cells under the title Reprogramming Postnatal Human Epidermal Keratinocytes Toward Functional Neural Crest Fates, was supported by grants from the National Institutes of Health.

Reference:

Bajpai, V. K., Kerosuo, L., Tseropoulos, G., Cummings, K. A., Wang, X., Lei, P., Liu, B., Liu, S., Popescu, G. K., Bronner, M. E. and Andreadis, S. T. (2017), Reprogramming Postnatal Human Epidermal Keratinocytes Toward Functional Neural Crest Fates. Stem Cells. doi:10.1002/stem.2583

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

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Stem Cells Reprogrammed without Genetic Modification - Technology Networks

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Science Daily

From skin to brain: Stem cells without genetic modification: Study ... Science Daily A discovery, several years in the making, demonstrates that adult skin cells can be converted into neural crest cells (a type of stem cell) without any genetic ... From skin to brain: Stem cells without genetic modification - UB Now ...University at Buffalo Reporter all 2 news articles »

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From skin to brain: Stem cells without genetic modification: Study ... - Science Daily

Spinal Cord Stem Cells Comments Off on From skin to brain: Stem cells without genetic modification: Study … – Science Daily | March 18th, 2017

Three women suffering from a degenerative eye condition were blindedlikely permanentlyin a clinical trial for stem cell therapy, according to a report published Wednesday in the New England Journal of Medicine.

The women, who were all between the ages of 72 and 88, had a common medical condition called age-related macular degeneration, in which cells in the retina begin to die off, resulting in spotty or blurred vision. Researchers suspected stem cells derived from the patient's own body could regenerate some of the cells lost to the disease. So in the clinical trial, which was conducted in 2015, researchers removed some blood and fat from participants' anesthetized abdomens, treated the cells in a standardized way to make them revert to stem cells, then injected into their eyes. They were instructed to use an eyedrops antibiotic for a few days. The three patients had found the trial listed on the government web site clinicaltrials.gov, and had each paid $5,000 for the procedure. The informed consent form listed that blindness was possible as a result of the procedure.

MoreIt's Shockingly Easy To Buy Unregulated Stem Cell Treatments

A few days after the patients received the injected stem cells, the participants ended up in the hospital with vision loss, detached retinas, and hemorrhage. The patients lost vision; subsequent checkups led doctors to conclude that they would likely never regain their sight.

Despite the fact that the participants found the procedure on clinicaltrials.gov, the informed consent forms do not mention that it is in fact a clinical trial. "The patients paid for a procedure that had never been studied in a clinical trial, lacked sufficient safety data, and was performed in both eyes on the same day," the study authors write. Injecting something experimental into both eyes is both not safe and not typical, they continue.

Recently researchers have been testing lots of different medical uses for stem cells, from treating multiple sclerosis to spinal cord injuries. With the passage of the 21st Century Cures Act in December, Congress cleared the way for faster regulatory approval for promising treatments based on stem cells. At least 13 clinical trials were registered to treat AMD alone as of November 2016, the article authors write.

But anecdotes like these bolster those who counsel restraint when it comes to stem cells. "Although numerous stem-cell therapies for medical disorders are being investigated at research institutions with appropriate regulatory oversight, many stem-cell clinics are treating patients with little oversight and with no proof of efficacy," the article authors write.

Jeffrey Goldberg, a professor of ophthalmology at Stanford University and one of the authors of the article, calls this a "call to awareness for patients, physicians and regulatory agencies of the risks of this kind of minimally regulated, patient-funded research," according to a press release.

The post Three Women Blinded In Stem Cell Clinical Trial appeared first on Vocativ.

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3 women blinded in stem cell clinical trial - AOL

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Electroacupuncture releases stem cells to relieve pain, promote tissue repair, study finds Science Daily "The acupuncture stimulus we're giving these animals has a rapid effect on neuroanatomical pathways that connect the stimulus point in the arm to responsive neurons in the spinal cord and into a region in the brain called the hypothalamus. In turn, the ...

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Electroacupuncture releases stem cells to relieve pain, promote tissue repair, study finds - Science Daily

Spinal Cord Stem Cells Comments Off on Electroacupuncture releases stem cells to relieve pain, promote tissue repair, study finds – Science Daily | March 18th, 2017

Three women suffering from a degenerative eye condition were blindedlikely permanentlyin a clinical trial for stem cell therapy, according to a report published Wednesday in the New England Journal of Medicine.

The women, who were all between the ages of 72 and 88, had a common medical condition called age-related macular degeneration, in which cells in the retina begin to die off, resulting in spotty or blurred vision. Researchers suspected stem cells derived from the patients own body could regenerate some of the cells lost to the disease. So in the clinical trial, which was conducted in 2015, researchers removed some blood and fat from participants anesthetized abdomens, treated the cells in a standardized way to make them revert to stem cells, then injected into their eyes. They were instructed to use an eyedrops antibiotic for a few days. The three patients had found the trial listed on the government web site clinicaltrials.gov, and had each paid $5,000 for the procedure. The informed consent form listed that blindness was possible as a result of the procedure.

A few days after the patients received the injected stem cells, the participants ended up in the hospital with vision loss, detached retinas, and hemorrhage. The patients lost vision; subsequent checkups led doctors to conclude that they would likely never regain their sight.

Despite the fact that the participants found the procedure on clinicaltrials.gov, the informed consent forms do not mention that it is in fact a clinical trial. The patients paid for a procedure that had never been studied in a clinical trial, lacked sufficient safety data, and was performed in both eyes on the same day, the study authors write. Injecting something experimental into both eyes is both not safe and not typical, they continue.

Recently researchers have been testing lots of different medical uses for stem cells, from treating multiple sclerosis to spinal cord injuries. With the passage of the 21st Century Cures Act in December, Congress cleared the way for faster regulatory approval for promising treatments based on stem cells. At least 13 clinical trials were registered to treat AMD alone as of November 2016, the article authors write.

But anecdotes like these bolster those who counsel restraint when it comes to stem cells. Although numerous stem-cell therapies for medical disorders are being investigated at research institutions with appropriate regulatory oversight, many stem-cell clinics are treating patients with little oversight and with no proof of efficacy, the article authors write.

Jeffrey Goldberg, a professor of ophthalmology at Stanford University and one of the authors of the article, calls this a call to awareness for patients, physicians and regulatory agencies of the risks of this kind of minimally regulated, patient-funded research, according to a press release.

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Three Women Blinded In Stem Cell Clinical Trial - Vocativ

Spinal Cord Stem Cells Comments Off on Three Women Blinded In Stem Cell Clinical Trial – Vocativ | March 16th, 2017

By Isaac GuererroStaff writer

Xue-Jun Li spends her days studying motor neurons, the cells that send signals from the brain to the body's voluntary muscles.

Motor neuron diseases are degenerative, which means that the muscles don't stop working all at once. When the motor neurons begin to fail, one slowly loses control of the arms and legs, the ability to swallow and, eventually, to breathe.

Scientists know very little about the human nervous system and what causes the motor neurons to stop functioning. Li has published more than 37 peer-reviewed manuscripts and has developed human stem cell models for spastic paraplegias and spinal muscular atrophy, which is the leading genetic cause of death for infants.

Li joined the University of Illinois College of Medicine at Rockford as an associate professor in the Biomedical Sciences Department last May. Her research is supported by the National Institute of Health and ALS Association, among others.

I love the satisfaction of new discoveries, new ideas you get from working in the lab, the interaction with students, she said. But any breakthrough you make is a collaboration.

Her stem cell research is concerned with, among other things, an attempt to better understand microtubule defects that disrupt signals from the brain to motor neurons along the spinal cord. Mitochondrial defects the mitochondria are the energy factories of the cells are another focus.

This fall, Li will teach a class that's a first for the university: stem cells and regenerative engineering.

Isaac Guerrero: 815-987-1361; iguerrero@rrstar.com;@isaac_rrs

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Transform 815: Xue Jun-Li's stem cell research in Rockford sheds light on motor neuron diseases - Rockford Register Star

Spinal Cord Stem Cells Comments Off on Transform 815: Xue Jun-Li’s stem cell research in Rockford sheds light on motor neuron diseases – Rockford Register Star | March 16th, 2017

March 09, 2017 07:03 ET | Source: Neuralstem, Inc.

-NSI-566 Achieved Robust Engraftment and Long-Term Survival After Transplantation-

- Data Published in Journal of Neurotrauma-

GERMANTOWN, Md., March 09, 2017 (GLOBE NEWSWIRE) -- Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on the development of nervous system therapies based on its neural stem cell technology, announced the recent publication of preclinical data on NSI-566 spinal cord-derived neural stem cells in Journal of Neurotrauma. These data showed robust engraftment and long-term survival of NSI-566 post transplantation in a rat model of penetrating ballistic-like brain injury (PBBI). NSI-566 is Neuralstems lead stem cell therapy candidate.

The study entitled, Amelioration of penetrating ballistic-like brain injury induced cognitive deficits after neuronal differentiation of transplanted human neural stem cells," was led by Ross Bullock, M.D., Ph.D., The Miami Project to Cure Paralysis, University of Miami School of Medicine. These are the first data from the 4-year proof-of-concept research program, funded by the United States Department of Defense, for NSI-566 in traumatic brain injury.

These data on NSI-566 are encouraging, particularly since researchers have long been challenged to achieve durable engraftment and survival of neural stem cells after transplantation, said Dr. Bullock. No long-term treatment beyond physical therapy is currently available to restore cognition after a traumatic brain injury. Transplantation of stem cells into the injured brain may allow a unique replacement therapy and fill a significant medical need.

Researchers transplanted NSI-566 into rats 7-10 days after PBBI. The rats were immunosuppressed to enable survival of NSI-566 neural stem cells. Robust engraftment with evidence of prominent neuronal differentiation was observed after 4 months, and axons from grafted cells extended a significant distance from the graft site along host white matter tracts.

These data continue to support our research and development platform. The results provide additional insight into our proprietary regionally specific stem cells and their potential benefits in nervous system disorders, said Karl Johe, Ph.D., Chief Scientific Officer, Neuralstem. We look forward to additional preclinical data from this collaboration with Dr. Bullocks group to support the potential use of NSI-566 in traumatic brain injury.

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 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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Neuralstem Announces Publication of NSI-566 Data in a Rodent Model of Traumatic Brain Injury - GlobeNewswire (press release)

Spinal Cord Stem Cells Comments Off on Neuralstem Announces Publication of NSI-566 Data in a Rodent Model of Traumatic Brain Injury – GlobeNewswire (press release) | March 10th, 2017

The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of March 9, 2017.

GAINERS

1. Ocera Therapeutics Inc. (OCRX)

Gained 71.82% to close Thursday's trading at $1.89.

News: The Company reported additional encouraging results from its Phase 2b STOP-HE study of intravenous (IV) OCR-002 in hospitalized patients with Hepatic Encephalopathy.

The initial STOP-HE results, reported in January 2017, had demonstrated highly statistically significant reduction in ammonia levels over placebo, strong evidence of benefit across multiple endpoints with higher doses (15g, 20g), clinical improvement dose trend, increased responder rate with increased dose and superiority over placebo at all doses. OCR-002 was also safe and well-tolerated.

The additional study data revealed on Thursday indicates that IV OCR-002 provided clinical benefit over placebo in other parameters as well, such as the Physician Overall Evaluation, Model for End-Stage Liver Disease (MELD) scores, and in renal function as measured by the change from baseline in Blood Urea Nitrogen (BUN) levels.

2. Cymabay Therapeutics Inc. (CBAY)

Gained 20.29% to close Thursday's trading at $4.09.

News: The Company will provide a corporate overview at the 29th Annual ROTH Conference on March 13th and at the Oppenheimer 27th Annual Healthcare Conference on March 21st.

Near-term catalysts:

- The results from phase II study of Cymabay's investigational drug Seladelpar in primary biliary cholangitis are expected in 3Q 2017. - The company's most advanced product candidate is Arhalofenate for treatment of gout, which has completed phase II studies. The drug candidate is licensed to Kowa Pharmaceuticals America, Inc. in the U.S.

Licensing discussions for other territories are underway. Ex-US licensing agreement for Arhalofenate is expected to be inked this year.

3. Neuralstem Inc. (CUR)

Gained 19.64% to close Thursday's trading at $5.30.

News: The preclinical data of the Company's NSI-566 spinal cord-derived neural stem cells in a rodent model of traumatic brain injury shows robust engraftment and long-term survival. The data are published in Journal of Neurotrauma.

NSI-566 is being explored in three indications: stroke, chronic spinal cord injury (cSCI), and Amyotrophic Lateral Sclerosis (ALS).

A phase I safety study of NSI-566 for the treatment of paralysis from chronic motor stroke is being conducted 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, according to the company.

Near-term catalyst:

-- Data from a phase II trial of NSI-189 for the treatment of major depressive disorder is expected in 3Q 2017.

4. Immunomedics Inc. (IMMU)

Gained 19.48% to close Thursday's trading at $6.01.

News: A global licensing agreement between Seattle Genetics (SGEN) and Immunomedics, worth over $2 billion, has been put on hold by a Delaware judge, following an injunction filed by venBio Select Advisor LLC, the largest shareholder of Immunomedics, to block the deal.

The license agreement between Seattle Genetics and Immunomedics was signed last month, and it involves antibody-drug conjugate, Sacituzumab govitecan, or IMMU-132.

Sacituzumab Govitecan (IMMU-132) is Immunomedics' lead investigational drug. As part of the agreement, Seattle Genetics is responsible for initiating phase III clinical trials of IMMU-132 in patients with metastatic triple-negative breast cancer (TNBC) and will be responsible for submitting the initial Biologics License Application to the FDA for accelerated approval.

VenBio is seeking to thwart the deal saying it undervalues the potential of IMMU-132. Now that a temporary restraining order has been placed on the deal, maybe there is an opportunity for a better deal.

5. Curis Inc. (CRIS)

Gained 20.78% to close Thursday's trading at $3.08.

News: The Company reported Q4 and full-year 2016 financial results and updated the progress of its pipeline.

The net loss for Q4, 2016 narrowed to $11.3 million or $0.08 per share on total revenue of $2.36 million. This compared with a net loss of $13.5 million or $0.10 per share and total revenue of $2.09 million in the year-ago period.

As for its clinical pipeline, the company noted that its phase I trial for CA-170 continues to progress on track through the dose escalation stage, and extension of the CA-170 Phase 1 study is all set to begin with enrollment of immunotherapy-nave patients in Korea and Spain, and with additional trial centers in other European countries projected to open in the second quarter.

A phase II trial of another drug candidate CUDC-907 in patients with relapsed/refractory MYC-altered diffuse large B cell lymphoma, or DLBCL , is expected to complete enrollment within the first half of this year.

6. VIVUS Inc. (VVUS)

Gained 16.35% to close Thursday's trading at $1.21.

News: The Company reported Q4 and full-year 2016 financial results.

VIVUS reversed to profit in the fourth quarter and full year of 2016 from net losses in the comparable year-ago periods.

Net income for the 2016 fourth quarter and full year was $56.6 million or $0.54 per share and $23.3 million or $0.22 per share, respectively, as compared to a net loss of $12.2 million or $0.12 per share and $93.1 million or $0.90 per share in 2015, respectively.

VIVUS had cash, cash equivalents and available-for-sale securities of $269.5 million at December 31, 2016.

The company noted that it will use its strong cash position for the acquisition and development of a new product pipeline to drive value creation for its stockholders while addressing the unmet needs of patients.

7. TG Therapeutics Inc. (TGTX)

Gained 16.26% to close Thursday's trading at $11.80. Shares of TG Therapeutics have been on the rise since announcing positive top line data from its phase III trial of TG-1101 in patients with high risk Chronic Lymphocytic Leukemia, dubbed GENUINE, on March 6, 2017.

News: The Company has priced an underwritten public offering of 5,128,206 shares of its common stock at a price of $9.75 per share.

Anticipated event: Q4 and full-year 2016 financial results and an update on business outlook for 2017 are slated to be presented on March 10, 2017.

LOSERS

1. InspireMD Inc. (NSPR)

Lost 37.56% to close Thursday's trading at $1.23.

News: The Company has priced its public offering of shares of Series C Convertible Preferred Stock, Series B warrants and Series C warrants.

Each share of Series C Convertible Preferred Stock is convertible into 4 shares of common stock at a conversion price equal to $1.60 per share. The Series B warrants have an exercise price of $2.00 per share of common stock and Series C warrants have an exercise price of $1.60 per share of common stock.

The gross proceeds from the offering are estimated to be up to $7.5 million. The offering is expected to close on or about March 14, 2017.

2. Cogentix Medical Inc. (CGNT)

Lost 13.12% to close Thursday's trading at $1.92.

News: The Company reported Q4 and full-year 2016 financial results.

Net loss for Q4 2016 widened to $18.57 million or $0.40 per share on revenue of $13.2 million. This compared with a net loss of $1.09 million or $0.04 per share and revenue of $13.64 million in the year-ago period.

3. BIOLASE Inc. (BIOL)

Lost 12.41% to close Thursday's trading at $1.20.

News: The Company reported Q4 and full-year 2016 financial results

The net loss for the fourth quarter of 2016 widened to $4.4 million or $0.07 per share as revenues declined to $13.8 million. This compared with a net loss of $2.5 million or $0.04 per share and revenue of $14.5 million in the fourth quarter of 2015.

4. Tandem Diabetes Care Inc. (TNDM)

Lost 11.63% to close Thursday's trading at $1.90.

News: The Company reported Q4 and full-year 2016 financial results.

The net loss for the fourth quarter of 2016 widened to $14.82 million or $0.48 per share as sales fell to $28.91 million. This compared with a net loss of $12.09 million or $0.40 per share and sales of $29.12 million in the fourth quarter of 2015. Tandem has also filed a registration statement on Form S-1 with the SEC relating to a proposed follow-on public offering of approximately $50 million of its common stock.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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Gainers & Losers Of Mar.9: CBAY, IMMU, TGTX, NSPR, TNDM... - RTT News

Spinal Cord Stem Cells Comments Off on Gainers & Losers Of Mar.9: CBAY, IMMU, TGTX, NSPR, TNDM… – RTT News | March 10th, 2017

Stem cell therapy is a quickly advancing treatment being used across the country. Now, its becoming more prevalent in eastern North Carolina to those living with chronic pain an alternative to surgery. The minimally invasive procedure is showing results in alleviating back, knee, hip and shoulder pain. Though stem cell therapy is classified by the Food and Drug Administration as experimental, patients say theyre finding relief. Meet New Bern resident and a local endodontist Dr. Donnie Luper. He was skeptical of the procedure at first.

How did you know what those stem cells were going to differentiate into? I mean was I going to grow a foot out of my shoulder or something like that?

Luper tore his rotator cuff 25 years ago during a tubing incident on the Trent River. A subsequent fall during a golf trip in 2015 sent him to a specialist.

I went to see a shoulder surgeon in Richmond. He told me that he didnt think it was a complete tear of my rotator cuff, that I could probably have a minor surgical procedure done and I asked him about stem cell.

After talking with a friend who opted for stem cell treatment for her knee pain, Luper decided to find out more.

My option was if I would have had that shoulder surgery and they had do that bicep tendon repair, I mean I would have been in a sling for six weeks and probably not working for three months.

According to the Food and Drug Administration, stem cells sometimes called the bodys master cells - have the ability to divide and develop into many different cell types. Each new cell has the potential to remain a stem cell or become another type of cell, such as a nerve cell, a skin cell, or a red blood cell. They may also help repair the body by dividing to replenish cells that are damaged by disease, injury or normal wear. Parkinsons disease, spinal cord injuries, damaged organs and cancer could all be possibly treated with the use of stem cells, but more research is needed. Dr. Angelo Tellis is the owner/physician of Aegean Medical, which provides stem cell therapy to patients in Cary, Jacksonville, Morehead City and New Bern.

The adult stem cells we call multipotent stem cells so they can only differentiate into very specific or certain kinds of tissue. Whereas the embryonic stem cells we call pluripotent and can become a variety, almost any tissue. But I only deal with adult stem cells, theyre found to be more useful in clinical applications.

Dr. Tellis says adult stem cells are more responsive to growing tissue in very specific locations. When patients go into Dr. Tellis office for the two hour procedure, he starts by numbing an area of the abdomen and performing liposuction to collect one or two syringes of body fat.

Stem cells can be found in a lot of different tissues throughout the body, but theyre actually in one of the highest concentrations in your own body fat.

The stem cell sample is combined with platelet rich plasma or PRP collected through a blood draw.

That has a lot of the chemical signals and messengers that activate stem cells. So Ill typically combine that with some of the stem cells collected from the body fat and then go under x-ray guidance and put it exactly in the targeted location where we want to create that healing process.

Soreness and stiffness can be expected immediately following the procedure and for about a week after. Dr. Tellis says the results tend to improve with time, taking about three to six months for full recovery. This was Lupers experience in 2016.

Really didnt have to take any pain medications. The joint was really sore over the weekend just because of the injection of the fluid there and after that, I had a small amount of discomfort, but nothing I really had to take medication for.

After three months, Luper says he felt 90 percent better. But he decided to get a second opinion from a shoulder surgeon.

And he told me he thought the stem cells had done a lot but that I still had one little bone spur that was rubbing against the muscle and constantly tearing the little bit of the muscle.

After surgery, Luper says his left shoulder started feeling significantly better in about a month. He was also able to return to one of his favorite pastimes golf. While surgery helped eliminate all of his pain, Luper believes stem cells helped regenerate tissue that was damaged years ago.

He said my rotator cuff muscle didnt even look like it had been torn. I actually tore that, Im sixty now, and I actually tore that when I was 34, 35 tubing on the river and I had to do physical therapy for about three months, but he said he saw absolutely no evidence that Id ever had a rotator cuff tear.

Even though some have found relief and possibly a cure through stem cell therapy, the Food and Drug Administration has not approved any stem cell-based products for use, other than HEMACORD (HE-muh-cord). According to their website, the use of stem cells raises safety concerns such as excessive cell growth, the development of tumors as well as cells migrating from the site of administration and differentiating into inappropriate cell types. And then, theres the cost of the procedure, which is not covered by insurance. The price for the treatment ranges from $2,500 to $5,000. But for those who want to avoid major surgery and the downtime associated with recovery, the risk and cost may be worth it.

If Id have surgery, my deductible would have been that because I have an out-of-pocket max. And I would want to do anything to avoid surgery, especially something that would keep me out of work for three months.

The FDA recommends that consumers interested in stem cell therapy should start a conversation with their doctor about the potential risk to benefit ratio. In addition to Aegean Medical, Advanced Health and Physical Medicine in Greenville and Regenerative Medicine Clinic of Wilmington also provide stem cell therapy in eastern North Carolina.

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Stem Cell Therapy An Option For ENC Patients | Public Radio East - Public Radio East

Spinal Cord Stem Cells Comments Off on Stem Cell Therapy An Option For ENC Patients | Public Radio East – Public Radio East | March 7th, 2017

A U.S. biotech company is preparing to start experiments using stem cells to try to stimulate 20 brain-dead patients back to life. And no, this isn't an elevator pitch for a sci-fi horror film.

The Mind Unleashed reports the company Bioquark will be trying to use stem cells to regrow and stimulate neurons to bring the patients back from brain death. It works like this: They implant stem cells in the patient's brain while also infusing the spinal cord with chemicals typically used to try and wake up coma patients. Then, hopefully, brain activity is essentially 'jump-started.' The technique is untested, so these experiments will go a long way toward proving (or disproving) the viability of the process.

Bioquark CEO Ira Pastor said they hope to see some results within 2-3 months after treatment begins, with the long-term goal being to develop techniques for brain-dead patients to eventually be able to make a full recovery. Which is certainly a heady, and ethically tricky, goal. You know, and also kind of scary. Ambitious and potentially live-saving, but still a little freaky.

What do you think of the technique? Is this going to revolutionize brain recovery or be the first step toward the T-virus?

(via The Mind Unleashed)

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Scientists moving ahead with research to resurrect the dead with stem cells - Blastr

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Science Times

Suicide Switch for Transplanted Stem Cells The Scientist The team then differentiated the iPSCs into neural stem and progenitor cells, and transplanted them into mice with a spinal cord injury. The mice began to recover some motor function, but as neural tumors and teratomas grew from the transplanted cells ... Stem Cell Assay Market, 2016-2024: By Type, Applications ...QWTJ LIVE One Stop all 17 news articles »

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Suicide Switch for Transplanted Stem Cells - The Scientist

Spinal Cord Stem Cells Comments Off on Suicide Switch for Transplanted Stem Cells – The Scientist | March 2nd, 2017

Notes This is a 7-day-old embryo that scientists kept alive in a laboratory dish. If it developed further, the clusters in green would become cells that shape the body and the red/purple cells would form the placenta.

Ali Brivanlou slides open a glass door at the Rockefeller University in New York to show off his latest experiments probing the mysteries of the human embryo.

"As you can see, all my lab is glass just to make sure there is nothing that happens in some dark rooms that gives people some weird ideas," says Brivanlou, perhaps only half joking.

Brivanlou knows that some of his research makes some people uncomfortable. That's one reason he has agreed to give me a look at what's going on.

His lab and one other discovered how to keep human embryos alive in lab dishes longer than ever before at least 14 days. That has triggered an international debate about a long-standing convention (one that's legally binding in some countries, though not in the U.S.) that prohibits studying human embryos that have developed beyond the two-week stage.

Ali Brivanlou's research team at Rockefeller University in New York was one of two groups internationally that figured out how to keep human embryos alive in lab dishes beyond the 14-day stage of development. Rob Stein/NPR hide caption

And in other experiments, he's using human stem cells to create entities that resemble certain aspects of primitive embryos. Though Brivanlou doesn't think these "embryoids" would be capable of developing into fully formed embryos, their creation has stirred debate about whether embryoids should be subject to the 14-day rule.

Brivanlou says he welcomes these debates. But he hopes society can reach a consensus to permit his work to continue, so he can answer some of humanity's most fundamental questions.

"If I can provide a glimpse of, 'Where did we come from? What happened to us, for us to get here?' I think that, to me, is a strong enough rationale to continue pushing this," he says.

For decades, scientists thought the longest an embryo could survive outside the womb was only about a week. But Brivanlou's lab, and one in Britain, announced last year in the journals Nature and Nature Cell Biology that they had kept human embryos alive for two weeks for the first time.

That enabled the scientists to study living human embryos at a crucial point in their development, a time when they're usually hidden in a woman's womb.

"Women don't even know they are pregnant at that stage. So it has always been a big black box," Brivanlou says.

Gist Croft, a stem cell biologist in Brivanlou's lab, shows me some samples, starting with one that's 12 days old.

"So you can see this with the naked eye," Croft says, pointing to a dish. "In the middle of this well, if you look down, there's a little white speck it looks like a grain of sand or a piece of dust."

Under a microscope, the embryo looks like a fragile ball of overlapping bubbles shimmering in a silvery light with thin hairlike structures extending from all sides.

Croft and Brivanlou explain that those willowy structures are what embryos would normally extend at this stage to search for a place to implant inside the uterus. Scientists used to think embryos could do that only if they were receiving instructions from the mother's body.

"The amazing thing is that it's doing its thing without any information from mom," Brivanlou says. "It just has all the information already in it. That was mind-blowing to me."

The embryos they managed to keep alive in the lab dish beyond seven days of development have also started secreting hormones and organizing themselves to form the cells needed to create all the tissues and organs in the human body.

The two scientists think studying embryos at this and later stages could lead to discoveries that might point to new ways to stop miscarriages, treat infertility and prevent birth defects.

"The only way to understand what goes wrong is to understand what happens normally, or as normally as we can, so we can prevent all of this," Brivanlou says.

The 14-day cutoff

But Brivanlou isn't keeping these embryos alive longer than 14 days because of the rule.

A long-standing rule prohibits scientists from keeping human embryos alive more than two weeks, after which the central nervous system starts to develop. The 14-day rule was developed decades ago to avoid raising too many ethical questions about experimenting on human embryos. It's a law in some countries, and just a guideline in the U.S.

"The decision about pulling the plug was probably the toughest decision I've made in my scientific career," he says. "It was sad for me."

The 14-day rule was developed decades ago to avoid raising too many ethical questions about experimenting on human embryos.

Two weeks is usually the moment when the central nervous system starts to appear in the embryo in a structure known as the "primitive streak."

It's also roughly the stage at which an embryo can no longer split into twins. The idea behind the rule is, that's when an embryo becomes a unique individual.

But the rule was initiated when no one thought it would ever be possible to keep embryos growing in a lab beyond two weeks. Brivanlou thinks it's time to rethink the 14-day rule.

"This is the moment," he says.

Scientists, bioethicists and others are debating the issue in the U.S., Britain and other countries. The rule is law in Britain and other countries and incorporated into widely followed guidelines in the United States.

Insoo Hyun, a bioethicist at Case Western Reserve University, advocates revisiting the rule. It would allow more research to be done on embryos that are destined to be destroyed anyway, he says embryos donated by couples who have finished infertility treatment.

"Given that it has to be destroyed," Hyun says, "some would argue that it's best to get as much information as possible scientifically from it before you destroy it."

But others find it morally repugnant to use human embryos for research at any stage of their development and argue that lifting the 14-day rule would make matters worse.

"Pushing it beyond 14 days only aggravates what is the primary problem, which is using human life in its earliest stages solely for experimental purposes," says Dr. Daniel Sulmasy, a Georgetown University bioethicist.

The idea of extending the 14-day rule even makes some people who support embryo research queasy, especially without first finding another clear stopping point.

Hank Greely, a Stanford University bioethicist, worries that going beyond 14 days could "really draws into question whether we're using humans or things that are well along the path to humans purely as guinea pigs and purely as experimental animals."

Embryo alternative: "Embryoids"

So as that debate continues, Brivanlou and his colleagues are trying to develop another approach. The scientists are attempting to coax human embryonic stem cells to organize themselves into entities that resemble human embryos. They are also using induced pluripotent stem (iPS) cells, which are cells that behave like embryonic stem cells, but can be made from any cell in the body.

Embryoids like this one are created from stem cells and resemble very primitive human embryos. Scientists hope to use them to learn more about basic human biology and development. Courtesy of Rockefeller University hide caption

Embryoids like this one are created from stem cells and resemble very primitive human embryos. Scientists hope to use them to learn more about basic human biology and development.

Brivanlou's lab has already shown that these "embryo-like structures" or "embryoids" can create the three fundamental cell types in the human body.

But the scientists have only been able to go so far using flat lab dishes. So the researchers are now trying to grow these embryonic-like structures in three dimensions by placing stem cells in a gel.

"Essentially, we're trying to, in a way, to re-create a human embryo in a dish starting from stem cells," says Mijo Simunovic, another of Brivanlou's colleagues.

In early experiments, Simunovic says, he has been able to get stem cells to "spontaneously" form a ball with a "cavity in its center." That's significant because that's what early human embryos do in the uterus.

Simunovic says it's unclear how close these structures could become to human embryos entities that have the capability to develop into babies.

"At the moment, we don't know. That's something that's very hot for us right now to try to understand," Simunovic says.

Simunovic argues the scientists are not "ethically limited to studying these cells and studying these structures" by the 14-day rule.

There's a debate about that, however.

"At what point is your model of an embryo basically an embryo?" asks Hyun, especially when the model seems to have "almost like this inner, budding life."

"Are we creating life that, in the right circumstances, if you were to transfer this to the womb it would continue its journey?" he asks.

Dr. George Daley, the dean of the Harvard Medical School and a leading stem cell researcher, says scientists have been preparing for the day when stem-cell research might raise such questions.

"I think what prospects people are concerned about are the kinds of dystopian worlds that were written about by Aldous Huxley in Brave New World," Daley says. "Where human reproduction is done on a highly mechanized scale in a petri dish."

Daley stresses scientists are nowhere near that, and may never get there. But science moves quickly. So Daley says it's important scientists move carefully with close ethical scrutiny.

The latest guidelines issued by the International Society for Stem Cell Research call for intensive ethical review, Daley notes.

Brivanlou acknowledges that some of his experiments have produced early signs of the primitive streak. But that's a very long way from being able to develop a spinal cord, or flesh and bones, let alone a brain. He dismisses the notion that the research on embryoids would ever lead to scientists creating humans in a lab dish.

"They will not get up start walking around. I can assure you that," he says, noting that full human embryonic development is a highly complex process that requires just the right mix of the biology, physics, geometry and other factors.

Nevertheless, Brivanlou says all of his experiments go through many layers of review. And he's convinced the research should continue.

"It would be a travesty," he says, "to decide that, somehow, ignorance is bliss."

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