Clinical Trials for Stem Cell - Spinal Cord Injuries Set to Begin

Clinical Trials for Stem Cell - Spinal Cord Injuries Set to Begin

StemCells, Inc. (Nasdaq:STEM) announced today the initiation of a Phase I/II clinical trial of its proprietary HuCNS-SC(R) human neural stem cells in chronic spinal cord injury. This trial is now open for enrollment, and will accrue patients with both complete and incomplete degrees of paralysis who are three to 12 months post-injury. The trial is being conducted in Switzerland at the Balgrist University Hospital, University of Zurich, a world leading medical center for spinal cord injury and rehabilitation, and is being led by Armin Curt, MD, Professor and Chairman, Spinal Cord Injury Center at the University of Zurich, and Medical Director of the Paraplegic Center at the Balgrist University Hospital.

Dr. Curt stated, "The launch of this trial is truly a landmark event for the field of spinal cord injury research. For patients facing a lifetime of paralysis, the prospect that neural stem cell transplantation may one day help restore some degree of function offers new hope. What is particularly exciting to me is the innovative design of this trial. Within the setting of one trial, we will progress from the most severely injured to less severely injured. In addition to our primary focus on assessing safety, the design of the trial will afford a very real near-term opportunity to observe possible benefits to the patient, which may include improved sensation, motor function, bowel or bladder function. I am extremely pleased to be involved in a study that is breaking barriers in the search for a treatment that could lead to improved quality of life for injured patients."

Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc., added, "Dr. Curt is an internationally renowned expert in spinal cord injury, and we look forward to working with him and his team of experienced investigators at Balgrist. Our HuCNS-SC cells have shown significant promise in preclinical studies for restoring lost motor function, and we are excited to take this important first step toward our goal of developing a neural stem cell therapy that could offer similar benefits for patients living with paralysis. We plan to enroll the first cohort of patients with complete injury this year, and will then transition to patients with incomplete injuries early next year."

About the Trial

The trial is designed to assess both safety and preliminary efficacy. The trial will enroll 12 patients with thoracic (chest-level) spinal cord injury who have a neurological injury level of T2-T11, and will include both complete and incomplete injuries as classified by the American Spinal Injury Association (ASIA) Impairment Scale. The first cohort will be patients classified as ASIA A, or patients who have what is considered to be a "complete" injury, or no movement or feeling below the level of the injury. The second cohort will progress to patients classified as ASIA B, or patients with some degree of feeling below the injury. The third cohort will consist of patients classified as ASIA C, or patients with some degree of movement below the injury. In addition to assessing safety, the trial will measure defined clinical endpoints, such as changes in sensation, motor, and bowel/bladder function. All patients will receive HuCNS-SC cells through direct transplantation into the spinal cord, and will be temporarily immunosuppressed. Following transplantation, the patients will be evaluated regularly over a 12-month period in order to monitor and evaluate the safety and tolerability of the HuCNS-SC cells, the surgery and the immunosuppression, and to measure any recovery of neurological function below the injury site. As the Company intends to follow the effects of this therapy long-term, a separate four-year observational study will be initiated at the conclusion of this trial. For information on patient enrollment, interested parties may contact the study nurse either by phone at +41 44 386 39 01, or by email at stemcells.pz@balgrist.ch.

Additional information about the Company's spinal cord injury program can be found on the StemCells, Inc. website at http://www.stemcellsinc.com/Therapeutic-Programs/Clinical-Trials.htm and at http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm, including video interviews with Company executives and independent collaborators.

About Chronic Spinal Cord Injury

Chronic spinal cord injury is characterized as a continuum of time after injury, which starts when inflammation has stabilized and behavioral recovery is reaching a plateau. The chronic phase typically does not set in until several months following the injury. To date, treatment approaches for neural repair and regeneration have generally targeted the acute and sub-acute time points, which are considered to be hours or days following injury. Restoring some degree of function for patients at later time points beyond the acute recovery phase could have a transformative impact on the field as there are no effective treatment options for these patients today. StemCells hopes to address a broad population of spinal cord-injured patients by opening the window of opportunity for therapeutic intervention to months or longer post-injury, and by targeting a wide range of injury levels and degrees of impairment.

About HuCNS-SC Cells

StemCells' lead product candidate, HuCNS-SC cells, is a highly purified composition of human neural stem cells that are expanded and stored as banks of cells. The Company's preclinical research has shown that HuCNS-SC cells can be directly transplanted in the central nervous system (CNS) with no sign of tumor formation or adverse effects. Because the transplanted HuCNS-SC cells have been shown to engraft and survive long-term, this suggests the possibility of a durable clinical effect following a single transplantation. StemCells believes that HuCNS-SC cells may have broad therapeutic application for many diseases and disorders of the CNS, and to date has demonstrated human safety data from completed and ongoing studies of these cells in two fatal brain disorders in children.

About Balgrist University Hospital

Balgrist University Hospital (www.balgrist.ch) is recognized worldwide as a highly specialized, leading center of excellence providing examination, treatment and rehabilitation opportunities to patients with serious musculoskeletal conditions. The clinic owes its first-rate international reputation to its unique combination of specialized medical services. The hospital's carefully-balanced, interdisciplinary network brings together medical specialties ranging from orthopedics, paraplegiology, radiology and anesthesiology to rheumatology and physical medicine under one roof.

About StemCells, Inc.

StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. In its therapeutic product development programs, StemCells is targeting disorders of the central nervous system and the liver. StemCells' lead product candidate, HuCNS-SC(R) cells (purified human neural stem cells), is currently in clinical development for spinal cord injury and two fatal neurodegenerative disorders in children, and in preclinical development for retinal disorders such as age-related macular degeneration. StemCells also markets stem cell research products, including media and reagents, under the SC Proven(R) brand, and is developing stem cell-based assay platforms for use in pharmaceutical research, drug discovery and drug development. Further information about StemCells is available at http://www.stemcellsinc.com.

Fat Accumulation In The Liver Leads To Disease But Certain Molecules Offer Protection

he liver normally makes and stores fat, which is required in moderation for normal body function. However, if the process goes awry, excess fat in the liver can cause major liver damage. In fact, fatty liver is a leading cause of liver failure in the United States, and is often brought on by obesity and diabetes. In turn, the increasing prevalence of these diseases has brought with it an epidemic of liver disease.

Abnormal sleep patterns, such as those of shift-workers, can be risk factors for obesity and diabetes. Investigators have known for decades that fat production by the liver runs on a 24-hour cycle, the circadian rhythm, and is similar to the sleep-wake cycle. A research team led by Mitchell Lazar, MD, PhD, director of the Institute for Diabetes, Obesity, and Metabolism at the University of Pennsylvania School of Medicine, has discovered molecules that act as "shift workers" to maintain the daily rhythm of fat metabolism. When those molecules do not do their jobs, the liver dramatically fills with fat. These findings are reported in this week's issue of Science.

Lazar and his colleagues, including Cell and Molecular Biology graduate student Dan Feng, found a team of molecules that, in normal mice, migrates to the genome of liver cells during the daytime. One of the team members, a protein called Rev-erb, delivers the molecular workers to thousands of specific locations in the liver genome, many of which are near genes involved in the production of fat. Another team member, called histone deacetylase 3 (HDAC3), does construction work on the protein scaffold (the epigenome) surrounding the genome to dampen the activity of the fat-related genes.

"This work shows that the epigenome, which is critical for regulating how genes are expressed, undergoes reversible remodeling every day", said Lazar. "This leads to a circadian rhythm of metabolism that is important, because disruption of this rhythm leads to fatty liver. This may explain in part why altered circadian rhythms in people who do shift work is associated with metabolic disorders."

Histones are proteins found in the nucleus that package and order DNA into structural units. Changes to these epigenetic structures alter how DNA folds in chromosomes, making genes less or more accessible to regulatory proteins and enzymes that copy genes into RNA messages.

Construction Team

During the night, the day shift molecules depart the liver genome, and fat production increases due to other regulatory molecules. The fat production is kept in check when the Rev-erb construction team returns to the genome the next day. However, if either Rev-erb or HDAC3 is prevented from doing its job, the cycles do not occur, and the liver fills with fat.

By sequencing the DNA associated with HDAC-3 in the liver the Penn team found HDAC in 100 places in the liver genome at 5:00am, but 12 hours later at 5:00pm, HDAC was present in 15,000 places in the liver genome, indicating that it had been brought to the liver during the day. They also found that Rev-erb follows the same daily pattern, because it is the protein that gives HDAC-3 a ride to work.

The Lazar lab is looking in other tissues - fat cells, muscle, for example - to see if the same team of molecules is at work, as well as delving deeper into human applications to see how the findings may help explain what goes wrong with fat production and storage in conditions such as metabolic syndrome, insulin resistance, and diabetes. These findings also raise the interesting question of whether certain drugs should be given at specific times of day, to have greater benefit with reduced side-effects. 
Notes: 

In addition to Lazar and Feng, Penn co-authors are Zheng Sun, Shannon Mullican, and Theresa Alenghat. The study was a collaboration with Tao Liu and X. Shirley Liu, at the Dana-Farber Cancer Institute in Boston. The National Institute of Diabetes, Digestive, and Kidney Diseases provided funding for this research. 

Source: 
Karen Kreeger
University of Pennsylvania School of Medicine 

HIV Diagnosis Is not a Death Warrant

HIV Diagnosis Is not a Death Warrant

Medical advances have transformed the prognosis for HIV. Being treated by an experienced HIV specialist is the vital first step. As both of you will be seeing a lot of each other over the years it is essential the two of you are able to discuss everything easily.

What the doctor will do.

Firstly the health care practitioner should get a history wanting to know about your general fitness & way of life, do a physical exam and take some blood for a battery of tests. This is the first of numerous opportunities you’ll have to ask appropriate questions. Females should possibly have a cervical smear & pregnancy test as well.

Questions you will intend to raise

There will almost certainly be plenty of questions buzzing in the cranium. A number of factors to bring up may take in the hazards & benefits of HIV treatment, how your chances of developing further conditions can be affected, lifestyle changes, adjustments you could make to keep yourself healthy & get out of passing on the virus.

The blood investigation you will undergo.

When you are initially diagnosed & on a regular basis onwards you’ll have a sequence of blood tests to establish a starting point and enable the effectiveness of the management to be measured.

The CD4 count measures how many CD4 cells in the blood. They’re a vital part of your immune system and help out the body to combat illness. HIV infection affects your CD4 cells, thus making the immune system compromised. The amount of CD4 cells you have is a complete signal of your immune system function and has an effect on the HIV signs and symptoms.

The viral lode test just examines how much of the HIV virus is there in the blood. It is one more measure of the proficiency of the body in combating the virus. you will undergo a HIV RNA amplification or a branched chain DNA test. It doesn’t if truth be told matter which you have as long as you always have the same test carried out for uniformity.

Like a lot of bacteria and viruses HIV may change as it spreads so before any treatment conclusions are ready you will have drug resistance testing carried out. This will help to suggest which combination of medicines most likely to be successful.

In addition you will most likely also have a quantity of regular blood test done, the same that are done in all conditions. These include full blood count, protein levels, kidney function & urine scrutiny.

With all these blood results to hand it helps you & the health professional to discuss your treatment options and plan as a result for a lengthy life. The science being carried out all over the globe means advances are being reported every day so treatment is constantly evolving.

For all you plan to understand on HIV cure visit this site. Grow healthy with thepersonal trainer birmingham.

Kids receive medical marijuana

Kids receive medical marijuana

Montana residents are expressing mixed feelings over children with medical conditions being allowed to use medical marijuana.

In Montana, there are more than 28,000 medical cannabis card holders, and 51 of them are under the age of 18.

"That's one of the things that I think is one of the biggest misperceptions is that there's a ton of kids that are out here that have cards that are in high school and junior high and that are buying this medical cannabis and giving it to their friends, and that's just simply not true," said Tayln Lang, director of Montana Medical Growers Association.

Children must follow certain guidelines to get medical marijuana. The minor's physician has to explain the potential risks and benefits of the medical use of marijuana; the custodial parent must consent to the use of medical marijuana; the custodial parent must agree to serve as the minor's caregiver; and the custodial parent must also control the acquisition, dosage and frequency of the use of marijuana by the minor.

"More often though, the children who are under the age of 18 have very, very, very serious medical conditions," Lang said.

Cash Hyde, 2, battled a brain tumor and won. Cash is one of the youngest medical cannabis patients in Montana.

"I believe that Cash is with us for a lot of reasons," said Michael Hyde, Cash's father. "You know, he is a patient of medical cannabis, which has I think greatly benefited his battle."

Cash's parents say they have watched as the drugs that were prescribed by doctors made Cash hallucinate and stopped his heart.

"I watched Cashy not be able to eat for over 40 days to the point where he couldn't lift his head up off his pillow," Hyde said. "I realized along the way in this journey that there is a quality of life that a lot of people do not have, and it's because of the drugs that they're given."

Some people are worried about the effect that medical marijuana may have on a young developing brain.

"The Tetrahydrocannabinol (THC) will interfere with concentration, learning, problem-solving and short-term memory. All the things that kids need, especially when they're in school and trying to learn," said Brandee Tyree, an Underage Substance Abuse Prevention specialist. "It's a substance that's hurtful for the brain during development. We believe it's harmful for kids, and in our opinion, no, we don't think kids should be using marijuana."

Hyde said he would advise people to do research on medical marijuana before they make a decision.

"If you or someone you know has battled cancer, I don't have to tell you how devastating it is to watch chemotherapy and cancer consume your loved one," Hyde said. "And when you can actually watch something that you're doing for them actually benefit them in a way that nobody else can do, you feel empowered - you feel like you can make a difference."

Montana is considering a repeal of its medical marijuana law. To make that happen, a bill has to pass in the state house and move to the Senate.

No Brain Damage From Ecstasy, New Research Shows

No Brain Damage From Ecstasy, New Research Shows  

Contrary to long-held opinion, ecstasy, the popular rave-culture drug, may not harm your brain.
This is according to one of the largest studies ever conducted on the illegal drug's effect on cognition, published last week in the journal Addiction.


Though former studies have concluded quite the opposite about the drug (technical name 3,4-Methylenedioxymethamphetamine, or MDMA) there's been concern that these conclusions were overstated and reached through faulty methods.


The latest research, a $1.8 million study funded by the National Institute on Drug Abuse (NIDA), set out to correct these methods by eliminating all other factors that could possibly contribute to mental impairment: 1) sleep deprivation and dehydration commonplace in rave culture, 2) previous habitual drug or alcohol use, or 3) former cognitive damage for any reason.


After screening subjects for these factors (even testing hair samples to make sure they weren't lying about drug use) researchers whittled down the initial pool of 1,500 people to just 52 cognitively clean subjects, the Guardian reports.


John Halpern, lead researcher from the Harvard Medical School team, told Addition:

Researchers have known for a long time that earlier studies of ecstasy use had problems that later studies should try to correct. When NIDA decided to fund this project, we saw an opportunity to design a better experiment and advance our knowledge of this drug.

Ecstasy is most commonly associated with the 1980s and 90s rave scene -- all-night dance complete with strobe lights and glow sticks to enhance the drug's effect. Ecstasy's symptoms include a feeling of euphoria, a heightened sense of intimacy and pleasure, and decreased anxiety. Negative side effects include blurred vision, and in rare cases overdoses can be fatal.

The common understanding, and certainly the argument from the anti-drug camp, has been that ecstasy can cause memory loss, pose a serious brain damage risk, and have long-lasting effects on behavior.
Researchers are quick to point out that despite the study's conclusion, ecstasy is still a dangerous drug. The illegal pills have no warning labels, and can contain a number of harmful contaminants.
Studies have also looked into MDMA-assisted psychotherapy as a possible treatment for post-traumatic stress disorder (PTSD). The idea is to provide at least a brief experience of what life feels like without the aftermath of trauma, to provide a state in which learning can occur.

What Do You Believe - Miracles or Science?

What Do You Believe - Miracles or Science? (Miracle Detectives) 

(RNS) Dirt at an ancient holy site in Chimayo, N.M. reputedly cures a woman's rare bone cancer.

In North Carolina, a 14-year-old girl stricken with pneumonia is removed from life support but survives after an angelic image appears on a security monitor outside her hospital room.

A Texas man lives despite being cut in half after being run over by a train.

Were these acts of God, or is there a scientific explanation for events that seem to defy reason?

For an hour every Wednesday night (10 p.m. EST), that divisive question is the focus of Miracle Detectives, one of prime-time television's first forays into exploring the miraculous.

The show features two investigators -- one a believer, the other a scientist -- who seek answers to "mysterious incidents that seem to transcend logic." It's one of 17 programs on the new Oprah Winfrey Network (OWN), which debuted New Year's Day.

In a society less devout than the United States, and in an era of near daily scientific breakthroughs, such a show might seem a waste of valuable air time. But polls in the U.S. consistently show that 80 percent of Americans believe miracles occur, and slightly more than half believe in guardian angels.

Miracle Detectives may be preaching to the converted: An OWN online survey found that more than 92 percent of those watching the program said they believe in miracles; nearly 3 percent said they do not; and almost 5 percent said they "need proof."

Each week, hosts Randall Sullivan, who says he experienced a miracle himself, and Indre Viskontas, a neuroscientist who sings in her church choir but approaches the supernatural with skepticism, visit the sites of reported miracles to hear first-hand accounts.

Interviewing experts and conducting experiments, the duo gathers information and attempts to answer the question: Miracle, or not?

Sullivan, 59, said there is no conflict being an evidence-hungry reporter while also believing in supernatural signs and wonders.

"A journalist's role is to explore," he said. "Yes, you're certainly seeking truth, but you're also exploring. First thing I want to know is, what happened to people? What did they experience? I want it from the inside out, from them and from me."

Viskontas, 34, holds a doctorate in cognitive neuroscience, but also calls herself "a very spiritual person," who was raised a Roman Catholic and is a soloist in her church choir. 

"I identify as a scientist," she says. "A scientist is interested in trying to understand the phenomenon in front of them. They're trying to get at what is actually happening."

An expert in how memories are formed and retrieved, Viskontas says she's in a unique position to discover what someone remembers, what actually happened and how circumstances led them to believe there is a supernatural force at work.

That doesn't mean she denies the possibility of the miraculous. In fact, she struggles with it.

"One of things I struggle with the most is the idea that an all-loving, all-powerful, all-knowing God would choose to use miracles in which to operate," says Viskontas.

"There are so many instances in which those miracles don't happen. It's very hard for me to believe that God would act in such a direct way, and it seems to me if that were true, then he's kind of an underachiever," she said.

Sullivan had a life-altering experience while covering the war in Bosnia in the 1990s for Rolling Stone magazine. Raised in an irreligious family, he found himself "skeptical and guarded" in the village of Medjugorje, where visions of the Virgin Mary have been reported, drawing pilgrims by the busload.

"I was there to observe, not to be a pilgrim," he recalls.

While climbing the Mountain of the Cross, the central feature in the village, Sullivan was caught up a violent thunderstorm and feared he might die. He encountered a group of nuns, singing in French and kneeling in prayer.

"For the very first time in my life I got down on my knees in the mud and stone and prayed with them and felt an immense sense of release and uplift," he recalled. "It was like a cork had been pulled out of a bottle."

A young woman draped a cloth on his shivering shoulders. "I felt instantly warmed and comforted. But when I opened my eyes, the nuns and the woman were gone."

No one else had seen or heard the nuns, Sullivan said. "The only thing that made me feel I wasn't completely insane was that I still had the cloth in my hand."

After struggling with the experience, Sullivan decided to embrace it and concluded that it had been a gift from God.

"That core belief inside is so deeply set that I really do believe there are miracles, and I approach most of these cases (on the program) wanting to believe," he said.

"But I'm certainly willing to check it out. If it's true, there's nothing to be lost challenging it."

Communication Pathways Within Proteins May Yield New Drug Targets To Stop Superbugs

Communication Pathways Within Proteins May Yield New Drug Targets To Stop Superbugs

A School of Science at Indiana University-Purdue University Indianapolis biophysicist has developed a new method to identify communication pathways connecting distant regions within proteins. 

With this tool, Andrew J. Rader, Ph.D., assistant professor of physics, has identified a mechanism for cooperative behavior within an entire molecule, a finding that suggests that in the future it may be possible to design drugs that target anywhere along the length of a molecule's communication pathway rather than only in a single location as they do today. The discovery holds promise for increasing the likelihood of therapeutic success. 

The study, "Correlating Allostery with Rigidity" is published in the current issue ofMolecular BioSystems, a journal of the Royal Society of Chemistry. 

Microorganisms frequently contain enzymes, protein molecules that carry out most of the important functions of cells, not present in human cells. Blocking these enzymes can stop or kill a harmful invader. 

Drugs are often developed to block or restrict the function of such enzymes, thereby treating the underlying infectious disease they convey. These drugs often target specific chemical sites on bacterial or viral enzymes, and alter the enzymes so they no longer function. Unfortunately, microorganisms can evolve enzymes that are impervious to these drugs, resulting in drug resistant organisms. 

"With the growth of drug resistant organisms, it is increasingly important that we gain a better understanding of what makes enzymes within cellular proteins do what they do, so that we can develop alternative approaches to targeting these proteins, shutting down enzymes and killing these superbugs," said Rader, first author of the study. 

He has found that the "poking" of one spot on the rigid pathway connecting regions within proteins produces communication along the entire pathway, indicating that drugs could be targeted to multiple locations on the pathways that had not developed drug resistance and could travel to where needed. His new method identified more than twice as many communication pathways as previous studies. 

To use the analogy of a railroad track, dislocating a single rail, anywhere on the track, effects the entire track as trains cannot travel from one end to the other due to the rail that is out of alignment. Returning the rail to its proper location makes the entire track function normally. In the case of the rigid pathways within proteins, affecting a single chemical locus on the pathway affects the entire pathway. 

"We now see in these rigid pathways that we can effect something at a distance. This holds great potential for drug targeting. We can do something at one site on the pathway, where drug resistance is not an issue, and it will affect another, perhaps turning an enzyme off and eliminating drug resistance. It's too early to say whether we can successfully counter tuberculosis, Methicillin-resistant Staphylococcus aureus [MRSA] and others of the growing number of multidrug resistant organisms this way, but it's a promising approach well worth further exploration," said Rader. 

Notes: 

This study by Rader, co-authored by graduate student Stephen M. Brown, was funded by the Department of Physics, School of Science at IUPUI.