In a new study, 60 mg of Cymbalta(R) (duloxetine HCl) taken once daily significantly reduced chronic low back pain, as measured by the Brief Pain Inventory (BPI) average pain rating, compared with placebo.(1) The data were presented at the annual meeting of the American Academy of Pain Medicine (AAPM) in San Antonio, Texas.
A total of 401 patients participated in the 12-week, double-blind, placebo-controlled study, designed to assess the efficacy of duloxetine 60 mg once daily on the reduction of pain severity in patients with chronic low back pain. In the study, duloxetine-treated patients experienced a statistically significantly greater improvement on BPI average pain scale compared with placebo in chronic low back pain (p
Cymbalta is approved in the United States for the treatment of major depressive disorder, the treatment of generalized anxiety disorder, the management of diabetic peripheral neuropathic pain and the management of fibromyalgia, all in adults (18+). Cymbalta is not approved for use in pediatric patients.
Indications and Important Safety Information for Cymbalta
Indications
Cymbalta is approved to treat major depressive disorder and generalized anxiety disorder, and to manage diabetic peripheral neuropathic pain and fibromyalgia.
Important Safety Information
Antidepressants can increase suicidal thoughts and behaviors in children, adolescents, and young adults. Suicide is a known risk of depression and some other psychiatric disorders. Patients should call their doctor right away if they experience new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Be especially observant within the first few months of treatment or after a change in dose. Cymbalta is approved only for adults 18 and over.
Cymbalta is not for everyone. Patients should not take Cymbalta if they have recently taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI), are taking Mellaril(R) (thioridazine), or have uncontrolled glaucoma (increased eye pressure). Patients should speak with their doctor about all their medical conditions including kidney or liver problems, glaucoma, diabetes, seizures, or if they have bipolar disorder. Cymbalta may worsen a type of glaucoma or diabetes. Patients should talk to their doctor if they have itching, right upper belly pain, dark urine, yellow skin or eyes, or unexplained flu-like symptoms, which may be signs of liver problems. Severe liver problems, sometimes fatal, have been reported. They should also talk to their doctor about alcohol consumption. Patients should tell their doctor about all their medicines, including those for migraine, to avoid a potentially life-threatening condition. Symptoms may include high fever, confusion, and stiff muscles. Taking Cymbalta with NSAID pain relievers, aspirin, or blood thinners may increase bleeding risk. Patients should consult with their doctor before stopping Cymbalta or changing the dose. If after starting Cymbalta, patients experience dizziness or fainting upon standing, they should contact their doctor. Cymbalta can increase blood pressure. Healthcare providers should check patients' blood pressure prior to and while taking Cymbalta. Patients should tell their doctor if they experience headache, weakness, confusion, problems concentrating, memory problems, or feel unsteady while taking Cymbalta as this may be signs of low sodium levels. Patients should consult their doctor if they develop problems with urine flow while taking Cymbalta or if they are pregnant or nursing.
The most common side effects of Cymbalta include nausea, dry mouth, sleepiness, and constipation. This is not a complete list of side effects. Cymbalta may cause sleepiness and dizziness. Until patients know how Cymbalta affects them, they should not drive a car or operate hazardous machinery.
About Eli Lilly and Company (NYSE: LLY)
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.
This press release contains forward-looking statements about the potential of Cymbalta for the management of chronic low back pain, and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that the product will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
References
(1) Skljarevski, et al. "Effect of Duloxetine 60 mg Once-daily Versus Placebo in Patients With Chronic Low Back Pain: A 12-week, Randomized, Double-blind Trial." Presented at 2010 American Academy of Pain Medicine Annual Meeting, Feb. 3, 2010.
(2) Thomas E, et al. BMJ. 1999;318:1662-1667.
(3) International Association for the Study of Pain. "IASP Pain Terminology"
(4) American Pain Society. "Pain Control in the Primary Care Setting." 2006:15.
Source: Eli Lilly and Company
View drug information on Cymbalta.
вторник, 21 июня 2011 г.
понедельник, 20 июня 2011 г.
Patients With Back Pain Recover Without Surgery
If you suffer from a ruptured disk in your lower back your will recover whether you have surgery or not. However, your pain will be eased earlier if you have surgery. US researchers, in two new studies suggest there is no harm in waiting if you don't want to undergo surgery.
You can read about this in the Journal of the American Medical Association (JAMA).
There was some resistance to the trial from surgeons who felt it would be wrong to ask patients in pain to forfeit surgery just to see whether they would recover. However, the trial went ahead and the researchers concluded that both surgery and waiting are effective - neither one is better than the other. In other words, the patient can safely decide whether he/she wants to wait or undergo surgery. In the USA, surgery costs about $6,000.
One study involved 472 patients, with an average age of 42. They were all followed up for two years after being randomly assigned either surgery or non-invasive treatment. The non-invasive treatment included education, physiotherapy (physical therapy) and painkilling drugs. Surgery meant taking out part of the swollen disk (outpatient basis). The researchers found that both groups experienced similar improvements and relief of pain over the two year period. 4% of patients who had surgery needed another operation within 12 months.
(North America - Physical Therapy. UK/Ireland/Australasia - Physiotherapy)
The other study involved 743 patients. In this study the patients chose whether they wanted surgery or not. The researchers found that the surgery patients experienced earlier pain relief. After three months 82% of surgery patients felt better, compared to 48% of non-surgery patients. By the end of two years the difference between the two groups was insignificant.
In neither study did any patient develop Cauda Equina Syndrome - a disabling condition - a fear many doctors and patients have if they do not have surgery. These two studies show compelling evidence that the fear is perhaps unnecessary. In other words, a patient can safely decide whether or not to have surgery.
The researchers believe these two studies will have a major impact on how lower back pain is treated in future. In the USA about 300,000 patients undergo surgery to relieve back pain each year. Patients are often told that if they do not have the operation they risk serious complications - the two studies showed the complications do not happen.
Surgeons' fears of complications if patients did not have an operation were real - before these two studies there was no way of knowing.
From what I can gather after reading the studies, surgery is more likely to get rid of the pain earlier. If you can tolerate the pain and are willing to wait (not have surgery), you most likely will get better without complications.
Surgical vs Nonoperative Treatment for Lumbar Disk Herniation
1. "The Spine Patient Outcomes Research Trial (SPORT): A Randomized Trial"
James N. Weinstein, DO, MSc; Tor D. Tosteson, ScD; Jon D. Lurie, MD, MS; Anna N. A. Tosteson, ScD; Brett Hanscom, MS; Jonathan S. Skinner, PhD; William A. Abdu, MD, MS; Alan S. Hilibrand, MD; Scott D. Boden, MD; Richard A. Deyo, MD, MPH
JAMA. 2006;296:2441-2450.
Click here to see abstract online
2. "The Spine Patient Outcomes Research Trial (SPORT) Observational Cohort"
James N. Weinstein, DO, MSc; Jon D. Lurie, MD, MS; Tor D. Tosteson, ScD; Jonathan S. Skinner, PhD; Brett Hanscom, MS; Anna N. A. Tosteson, ScD; Harry Herkowitz, MD; Jeffrey Fischgrund, MD; Frank P. Cammisa, MD; Todd Albert, MD; Richard A. Deyo, MD, MPH
JAMA. 2006;296:2451-2459.
Click here to see abstract online
Another article that may be of interest:
"Surgical Treatment of Lumbar Disk Disorders"
Eugene Carragee, MD
JAMA. 2006;296:2485-2487
Click here to see editorial
Written by:
You can read about this in the Journal of the American Medical Association (JAMA).
There was some resistance to the trial from surgeons who felt it would be wrong to ask patients in pain to forfeit surgery just to see whether they would recover. However, the trial went ahead and the researchers concluded that both surgery and waiting are effective - neither one is better than the other. In other words, the patient can safely decide whether he/she wants to wait or undergo surgery. In the USA, surgery costs about $6,000.
One study involved 472 patients, with an average age of 42. They were all followed up for two years after being randomly assigned either surgery or non-invasive treatment. The non-invasive treatment included education, physiotherapy (physical therapy) and painkilling drugs. Surgery meant taking out part of the swollen disk (outpatient basis). The researchers found that both groups experienced similar improvements and relief of pain over the two year period. 4% of patients who had surgery needed another operation within 12 months.
(North America - Physical Therapy. UK/Ireland/Australasia - Physiotherapy)
The other study involved 743 patients. In this study the patients chose whether they wanted surgery or not. The researchers found that the surgery patients experienced earlier pain relief. After three months 82% of surgery patients felt better, compared to 48% of non-surgery patients. By the end of two years the difference between the two groups was insignificant.
In neither study did any patient develop Cauda Equina Syndrome - a disabling condition - a fear many doctors and patients have if they do not have surgery. These two studies show compelling evidence that the fear is perhaps unnecessary. In other words, a patient can safely decide whether or not to have surgery.
The researchers believe these two studies will have a major impact on how lower back pain is treated in future. In the USA about 300,000 patients undergo surgery to relieve back pain each year. Patients are often told that if they do not have the operation they risk serious complications - the two studies showed the complications do not happen.
Surgeons' fears of complications if patients did not have an operation were real - before these two studies there was no way of knowing.
From what I can gather after reading the studies, surgery is more likely to get rid of the pain earlier. If you can tolerate the pain and are willing to wait (not have surgery), you most likely will get better without complications.
Surgical vs Nonoperative Treatment for Lumbar Disk Herniation
1. "The Spine Patient Outcomes Research Trial (SPORT): A Randomized Trial"
James N. Weinstein, DO, MSc; Tor D. Tosteson, ScD; Jon D. Lurie, MD, MS; Anna N. A. Tosteson, ScD; Brett Hanscom, MS; Jonathan S. Skinner, PhD; William A. Abdu, MD, MS; Alan S. Hilibrand, MD; Scott D. Boden, MD; Richard A. Deyo, MD, MPH
JAMA. 2006;296:2441-2450.
Click here to see abstract online
2. "The Spine Patient Outcomes Research Trial (SPORT) Observational Cohort"
James N. Weinstein, DO, MSc; Jon D. Lurie, MD, MS; Tor D. Tosteson, ScD; Jonathan S. Skinner, PhD; Brett Hanscom, MS; Anna N. A. Tosteson, ScD; Harry Herkowitz, MD; Jeffrey Fischgrund, MD; Frank P. Cammisa, MD; Todd Albert, MD; Richard A. Deyo, MD, MPH
JAMA. 2006;296:2451-2459.
Click here to see abstract online
Another article that may be of interest:
"Surgical Treatment of Lumbar Disk Disorders"
Eugene Carragee, MD
JAMA. 2006;296:2485-2487
Click here to see editorial
Written by:
воскресенье, 19 июня 2011 г.
Chronic Pain Relieved By Strength Training Of Neck Muscles
Neck pain has been steadily increasing over the past two decades and is now second to back pain, the most common musculoskeletal disorder. Women are more likely than men to suffer from persistent neck pain, in particular those who engage in repetitive tasks such as working at a computer keyboard. Previous studies have shown conflicting results as to whether or not exercise can effectively treat neck pain, but there has not been enough high-quality research in this area to draw firm conclusions. A new study on women with neck pain published in the January issue of Arthritis Care & Research found that specific strength training exercises led to significant prolonged relief of neck muscle pain, while general fitness training resulted in only a small amount of pain reduction.
Led by Gisela SjГёgaard and Lars L. Andersen of the National Research Centre for the Working Environment in Copenhagen, Denmark, researchers conducted a randomized controlled trial for which they recruited 94 women from seven workplaces in Copenhagen between September 2005 and March 2006. The work tasks performed by the women consisted of assembly line work and office work, with 79 percent of the participants using a keyboard for more than three-quarters of their working time. Participants first answered a questionnaire about their pain and then underwent a clinical exam to confirm a diagnosis of trapezius myalgia (muscle pain in the trapezius muscle, which extends along the back of the neck). Participants were assigned to three intervention groups: those who did supervised specific strength training (SST) exercises for the neck and shoulder muscles, those who did high-intensity general fitness training (GFT) on a bicycle ergometer, and a control group that received health counseling but no physical training. Both exercise groups worked out for 20 minutes three times a week for 10 weeks.
The results showed that the GFT group showed a small decrease in neck muscle pain only immediately after exercise, while the SST group showed a marked decrease in pain over a prolonged training period and with a lasting effect after the training ended. "Thus specific strength training locally of the neck and shoulder muscles is the most beneficial treatment in women with chronic neck muscle pain," the authors state.
The study also showed that the reduction in pain occurred gradually in the SST group, with trapezius muscle pain gradually decreasing as muscle strength increased. Although the GFT decreased the pain only temporarily, the authors note that even minor decreases in pain may be enough motivation to overcome barriers to exercise, and the resulting increase in fitness may benefit overall long-term health.
The authors state that the marked reduction in pain in the SST group is of "major clinical importance." They conclude: "Based on the present results, supervised high-intensity dynamic strength training of the painful muscle 3 times a week for 20 minutes should be recommended in the treatment of trapezius myalgia."
Article: "Effect of Two Contrasting Types of Physical Exercise on Chronic Neck Muscle Pain," Lars L. Andersen, Michael Kjær, Karen Søgaard, Lone Hansen, Ann I. Kryger, Gisela Sjøgaard, Arthritis Care & Research , January 2008; 59:1; pp. 84-91.
Source: Amy Molnar
Wiley-Blackwell
Led by Gisela SjГёgaard and Lars L. Andersen of the National Research Centre for the Working Environment in Copenhagen, Denmark, researchers conducted a randomized controlled trial for which they recruited 94 women from seven workplaces in Copenhagen between September 2005 and March 2006. The work tasks performed by the women consisted of assembly line work and office work, with 79 percent of the participants using a keyboard for more than three-quarters of their working time. Participants first answered a questionnaire about their pain and then underwent a clinical exam to confirm a diagnosis of trapezius myalgia (muscle pain in the trapezius muscle, which extends along the back of the neck). Participants were assigned to three intervention groups: those who did supervised specific strength training (SST) exercises for the neck and shoulder muscles, those who did high-intensity general fitness training (GFT) on a bicycle ergometer, and a control group that received health counseling but no physical training. Both exercise groups worked out for 20 minutes three times a week for 10 weeks.
The results showed that the GFT group showed a small decrease in neck muscle pain only immediately after exercise, while the SST group showed a marked decrease in pain over a prolonged training period and with a lasting effect after the training ended. "Thus specific strength training locally of the neck and shoulder muscles is the most beneficial treatment in women with chronic neck muscle pain," the authors state.
The study also showed that the reduction in pain occurred gradually in the SST group, with trapezius muscle pain gradually decreasing as muscle strength increased. Although the GFT decreased the pain only temporarily, the authors note that even minor decreases in pain may be enough motivation to overcome barriers to exercise, and the resulting increase in fitness may benefit overall long-term health.
The authors state that the marked reduction in pain in the SST group is of "major clinical importance." They conclude: "Based on the present results, supervised high-intensity dynamic strength training of the painful muscle 3 times a week for 20 minutes should be recommended in the treatment of trapezius myalgia."
Article: "Effect of Two Contrasting Types of Physical Exercise on Chronic Neck Muscle Pain," Lars L. Andersen, Michael Kjær, Karen Søgaard, Lone Hansen, Ann I. Kryger, Gisela Sjøgaard, Arthritis Care & Research , January 2008; 59:1; pp. 84-91.
Source: Amy Molnar
Wiley-Blackwell
суббота, 18 июня 2011 г.
MRI Abundance May Lead To Excess In Back Surgeries, Stanford Study Shows
Patients reporting new low-back pain are more likely to undergo surgery if treated in an area with a higher-than-average concentration of magnetic resonance imaging machines, according to research from the Stanford University School of Medicine.
This may be bad news for patients, since previous studies have found that increased surgery rates don't improve patient outcomes. "The worry is that many people will not benefit from the surgery, so heading in this direction is concerning," said senior author Laurence Baker, PhD, professor of health research and policy.
In their new study, to be published online Oct. 14 in Health Affairs, Baker and first author Jacqueline Baras correlate areas with high numbers of MRI machines to an increased likelihood that MRIs will be performed on new low-back pain patients. In turn, high local MRI availability correlates with increased rates of low-back surgery.
"It is important that policymakers recognize that infrastructure matters, and that the number of MRI machines in any particular area may affect the volume and quality of health care that patients receive," said Baras, a Stanford medical student with a master's degree in health services research.
Low-back pain was the fifth-most common reason for physician visits in the United States, with 26.4 percent of adults reporting low-back pain for a day or more during a three-month period in 2002. More than 80 percent of low-back pain was diagnosed as nonspecific, a category that includes lumbar strains and sprains, degenerative disk disease and spinal instability.
MRIs visualize the body's internal structure and allow doctors to rule out some specific causes of back pain. However, MRIs may also detect anomalies unrelated to back pain, prompting doctors to perform surgery that may not benefit the patient, the authors noted.
To determine how MRI technology influences patient treatment, the researchers collected data on traditional Medicare patients who received care for nonspecific low-back pain from 1998 through 2005. Patient data were linked with the number of MRI machines in the area. The areas of MRI availability were then divided into four groups, from high to low, and the incidence of MRI scans and surgeries were determined in each group.
Researchers projected that in 2004 there would have been 5.4 percent fewer low-back MRIs and 9 percent fewer back surgeries if all Medicare patients reporting new-onset low-back pain had been living in the areas of lowest MRI availability.
Two-thirds of the MRI scans that appear to result from increased availability happened within the first month of onset. Clinical guidelines recommend delaying MRI use until four weeks after onset, during which time most low-back pain patients show spontaneous improvement. "Not only are patients in high-availability areas getting more MRIs, but they are getting them earlier," said Baras.
Between 2000 and 2005, the MRI availability in the United States more than tripled, from 7.6 machines per 1 million persons to 26.6 machines. Each machine costs more than $2 million and one low-back scan costs $1,500. Increased rates of scans and surgeries are increasing the cost to treat low-back pain, the authors said.
Doctors and patients face difficult decisions when using high-tech medical equipment, such as MRIs. "The big issue is how we handle new and exciting technologies in ways that allow us to reap the benefits of medical advances, without letting all of our new things generate waste or, worse, actual reductions in patient well-being," said Baker.
John Birkmeyer, MD, professor of surgery and a health policy researcher at the University of Michigan, who was not involved in the Stanford study, said the research confirms fears that greater access to MRI technology leads to more back surgeries. "The net result is increased risks of unnecessary surgery for patients and increased costs for everybody else," Birkmeyer said.
This research was funded by the California Healthcare Foundation and the Stanford Medical Scholars Research Program.
Source:
Michelle Brandt
Stanford University Medical Center
This may be bad news for patients, since previous studies have found that increased surgery rates don't improve patient outcomes. "The worry is that many people will not benefit from the surgery, so heading in this direction is concerning," said senior author Laurence Baker, PhD, professor of health research and policy.
In their new study, to be published online Oct. 14 in Health Affairs, Baker and first author Jacqueline Baras correlate areas with high numbers of MRI machines to an increased likelihood that MRIs will be performed on new low-back pain patients. In turn, high local MRI availability correlates with increased rates of low-back surgery.
"It is important that policymakers recognize that infrastructure matters, and that the number of MRI machines in any particular area may affect the volume and quality of health care that patients receive," said Baras, a Stanford medical student with a master's degree in health services research.
Low-back pain was the fifth-most common reason for physician visits in the United States, with 26.4 percent of adults reporting low-back pain for a day or more during a three-month period in 2002. More than 80 percent of low-back pain was diagnosed as nonspecific, a category that includes lumbar strains and sprains, degenerative disk disease and spinal instability.
MRIs visualize the body's internal structure and allow doctors to rule out some specific causes of back pain. However, MRIs may also detect anomalies unrelated to back pain, prompting doctors to perform surgery that may not benefit the patient, the authors noted.
To determine how MRI technology influences patient treatment, the researchers collected data on traditional Medicare patients who received care for nonspecific low-back pain from 1998 through 2005. Patient data were linked with the number of MRI machines in the area. The areas of MRI availability were then divided into four groups, from high to low, and the incidence of MRI scans and surgeries were determined in each group.
Researchers projected that in 2004 there would have been 5.4 percent fewer low-back MRIs and 9 percent fewer back surgeries if all Medicare patients reporting new-onset low-back pain had been living in the areas of lowest MRI availability.
Two-thirds of the MRI scans that appear to result from increased availability happened within the first month of onset. Clinical guidelines recommend delaying MRI use until four weeks after onset, during which time most low-back pain patients show spontaneous improvement. "Not only are patients in high-availability areas getting more MRIs, but they are getting them earlier," said Baras.
Between 2000 and 2005, the MRI availability in the United States more than tripled, from 7.6 machines per 1 million persons to 26.6 machines. Each machine costs more than $2 million and one low-back scan costs $1,500. Increased rates of scans and surgeries are increasing the cost to treat low-back pain, the authors said.
Doctors and patients face difficult decisions when using high-tech medical equipment, such as MRIs. "The big issue is how we handle new and exciting technologies in ways that allow us to reap the benefits of medical advances, without letting all of our new things generate waste or, worse, actual reductions in patient well-being," said Baker.
John Birkmeyer, MD, professor of surgery and a health policy researcher at the University of Michigan, who was not involved in the Stanford study, said the research confirms fears that greater access to MRI technology leads to more back surgeries. "The net result is increased risks of unnecessary surgery for patients and increased costs for everybody else," Birkmeyer said.
This research was funded by the California Healthcare Foundation and the Stanford Medical Scholars Research Program.
Source:
Michelle Brandt
Stanford University Medical Center
пятница, 17 июня 2011 г.
BrainStorm's NurOwn™ Stem Cell Technology Shows Promise For Treating Sciatic Nerve Injury
BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI), a leading developer of adult stem cell technologies and therapeutics, announced that intramuscular transplantation of autologous, astrocyte-like cells that produce and secrete neurotrophic factors (NTFs), representing the company's NuOwn™ technology platform, preserved motor function, significantly inhibited the degeneration of the neuromuscular junctions (NMJs), and preserved the myelinated motor axons in an animal sciatic nerve injury model. Results of the study appear in the online edition of the journal Stem Cell Reviews and Reports.
"The findings from this study demonstrating that BrainStorm's autologous NurOwn™ stem cell therapy can alleviate signs of sciatic nerve injury is an important milestone for the company," said Chaim Lebovits, President of BrainStorm. "One of the major caveats of stem cell transplantation is the fate of the transplanted cells. In the current study, we show that our transplanted cells can integrate and survive in the host muscles of animals after sciatic nerve crush for at least 3 weeks. This preclinical work provides additional support for the upcoming Phase 1 clinical trial of NurOwn™ for patients with amyotrophic lateral sclerosis (ALS) and other neurological disorders."
In a study conducted at Tel Aviv University, mesenchymal stem cells (MSCs) isolated from the femurs and tibias of adult rats were developed into NurOwn™ using a two-step medium based differentiating protocol to induce the MSCs into NTF secreting cells. These cells produce and release high amounts of NTFs, such as glial derived neurotrophic factor (GDNF) and brain derived neurotrophic factor (BDNF). The NTF secreting cells (NurOwn™) were labeled with superparamagnetic iron oxide (SPIO) to enable tracking of surviving cells following injection into the muscles of the right hind limb 24-hours after sciatic nerve crush.
Four days after transplantation, there was a statistically significant beneficial effect on the motor function in the NurOwn™ treated animals compared to the control rats, which did not receive cell transplants, or rats transplanted with non-differentiated MSCs. The high compound muscle action potential and low latency indices recorded in the hind limb muscles of NurOwn™ treated animals provided evidence that NurOwn™ preserved the myelinated motor axons and innervated peripheral muscles. Histology of the animal's hind limb muscles 3-weeks after transplantation revealed significant amount of pre-labeled NurOwn™ cells and high levels of BDNF in the muscles.
About Sciatica
One of the most common peripheral neuropathy is sciatica, damage to the sciatic nerve, with a high reported prevalence. Sciatica is characterized by muscle weakness, reflex changes and numbness. Tumors, cysts or other extraspinal insults can cause sciatica. The majority of sciatica patients suffer from persistent and severe types of pain, motor dysfunctions and prolonged disability.
About Amyotrophic Lateral Sclerosis
Amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's Disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. According to the ALS Association, approximately 5,600 people in the U.S. are diagnosed with ALS each year and it is estimated that as many as 30,000 Americans may have the disease at any given time. The financial cost to families of patients is exceedingly high, and it is estimated that in the advanced stage, care can cost an average of $200,000 per year, which represents more than a $6 billion cost to the healthcare system.
About NurOwn™
BrainStorm's core technology, NurOwn™, is based on the scientific achievements of Professor Eldad Melamed, former Head of Neurology, Rabin Medical Center, and Tel-Aviv University, and a member of the Scientific Committee of the Michael J. Fox Foundation for Parkinson's Research, and Professor Daniel Offen, Head of the Neuroscience Laboratory, Felsenstein Medical Research Center (FMRC) at the Tel-Aviv University.
The NurOwn™ technology processes adult human mesenchymal stem cells that are present in bone marrow and are capable of self-renewal as well as differentiation into many other cell types. The research team is among the first to have successfully achieved the in vitro differentiation of adult bone marrow cells (animal and human) into astrocyte-like cells capable of releasing neurotrophic factors, including glial-derived neurotrophic factor (GDNF). The ability to induce differentiation into astrocyte-like cells along with intramuscular or intrathecal (or other) delivery makes NurOwn™ technology highly attractive for treating ALS and Parkinson's disease as well as MS and spinal cord injury.
BrainStorm's stem cell therapy contains human mesenchymal stromal cells induced to differentiate into astrocyte-like cells secreting neurotrophic factors by means of a specific differentiation-inducing culture medium.
Source:
BrainStorm Cell Therapeutics, Inc.
"The findings from this study demonstrating that BrainStorm's autologous NurOwn™ stem cell therapy can alleviate signs of sciatic nerve injury is an important milestone for the company," said Chaim Lebovits, President of BrainStorm. "One of the major caveats of stem cell transplantation is the fate of the transplanted cells. In the current study, we show that our transplanted cells can integrate and survive in the host muscles of animals after sciatic nerve crush for at least 3 weeks. This preclinical work provides additional support for the upcoming Phase 1 clinical trial of NurOwn™ for patients with amyotrophic lateral sclerosis (ALS) and other neurological disorders."
In a study conducted at Tel Aviv University, mesenchymal stem cells (MSCs) isolated from the femurs and tibias of adult rats were developed into NurOwn™ using a two-step medium based differentiating protocol to induce the MSCs into NTF secreting cells. These cells produce and release high amounts of NTFs, such as glial derived neurotrophic factor (GDNF) and brain derived neurotrophic factor (BDNF). The NTF secreting cells (NurOwn™) were labeled with superparamagnetic iron oxide (SPIO) to enable tracking of surviving cells following injection into the muscles of the right hind limb 24-hours after sciatic nerve crush.
Four days after transplantation, there was a statistically significant beneficial effect on the motor function in the NurOwn™ treated animals compared to the control rats, which did not receive cell transplants, or rats transplanted with non-differentiated MSCs. The high compound muscle action potential and low latency indices recorded in the hind limb muscles of NurOwn™ treated animals provided evidence that NurOwn™ preserved the myelinated motor axons and innervated peripheral muscles. Histology of the animal's hind limb muscles 3-weeks after transplantation revealed significant amount of pre-labeled NurOwn™ cells and high levels of BDNF in the muscles.
About Sciatica
One of the most common peripheral neuropathy is sciatica, damage to the sciatic nerve, with a high reported prevalence. Sciatica is characterized by muscle weakness, reflex changes and numbness. Tumors, cysts or other extraspinal insults can cause sciatica. The majority of sciatica patients suffer from persistent and severe types of pain, motor dysfunctions and prolonged disability.
About Amyotrophic Lateral Sclerosis
Amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's Disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. According to the ALS Association, approximately 5,600 people in the U.S. are diagnosed with ALS each year and it is estimated that as many as 30,000 Americans may have the disease at any given time. The financial cost to families of patients is exceedingly high, and it is estimated that in the advanced stage, care can cost an average of $200,000 per year, which represents more than a $6 billion cost to the healthcare system.
About NurOwn™
BrainStorm's core technology, NurOwn™, is based on the scientific achievements of Professor Eldad Melamed, former Head of Neurology, Rabin Medical Center, and Tel-Aviv University, and a member of the Scientific Committee of the Michael J. Fox Foundation for Parkinson's Research, and Professor Daniel Offen, Head of the Neuroscience Laboratory, Felsenstein Medical Research Center (FMRC) at the Tel-Aviv University.
The NurOwn™ technology processes adult human mesenchymal stem cells that are present in bone marrow and are capable of self-renewal as well as differentiation into many other cell types. The research team is among the first to have successfully achieved the in vitro differentiation of adult bone marrow cells (animal and human) into astrocyte-like cells capable of releasing neurotrophic factors, including glial-derived neurotrophic factor (GDNF). The ability to induce differentiation into astrocyte-like cells along with intramuscular or intrathecal (or other) delivery makes NurOwn™ technology highly attractive for treating ALS and Parkinson's disease as well as MS and spinal cord injury.
BrainStorm's stem cell therapy contains human mesenchymal stromal cells induced to differentiate into astrocyte-like cells secreting neurotrophic factors by means of a specific differentiation-inducing culture medium.
Source:
BrainStorm Cell Therapeutics, Inc.
четверг, 16 июня 2011 г.
Rat Model Provides Insights Into Sciatica
A newly developed animal model for the painful nerve condition known as sciatica should help researchers diagnose and treat it, according to Duke University bioengineers and surgeons.
Sciatica is not a single disorder, but rather a diverse range of symptoms, such as numbness or pain from the lower back to the feet, radiating leg pain or difficulty in controlling the leg. It is often caused by compression, or pinching, of any of the five nerve roots that combine to make up the sciatic nerve. These roots are the parts of the nerve that pass through openings in the spine to the spinal cord.
Surgical simulation of nerve compression in rats was led by Mohammed Shamji, a neurosurgery resident and recent Ph.D. graduate working in the laboratory of senior researcher Lori Setton, professor of biomedical engineering and surgery at Duke's Pratt School of Engineering. Shamji and post-doctoral research fellow Kyle Allen observed that the animals' gait became asymmetric, and that they over-responded to temperature changes and touch in their limbs after the surgery.
They also found, for the first time, that the physical symptoms experienced by the affected animals seemed to be linked to an increase in levels of interleukin-17 (IL-17), a protein involved in regulating the inflammatory response. Elevated levels of IL-17 have already been implicated in such autoimmune diseases as rheumatoid arthritis and asthma.
"This finding suggests a possible role for immune system activation in contributing to symptoms of sciatica," said Shamji, now completing his neurosurgical residency at the Ottawa Hospital in Canada. "This offers new insight into the pathophysiology of the disease, and may also identify novel therapeutic targets to treat it."
The results of Shamji's and Allen's experiments were published online in the journal Spine.
"If immune system activation is involved, and it turns out to be an important part of the condition, it is possible that existing or new drugs that can block this immune response could offer relief to patients," Setton said. "This new model should help us find answers for a disorder that has few good treatments."
For their experiments, the researchers compressed a specific nerve root known as the dorsal root ganglia in the lumbar region of the spine, which simulated sciatica in one of the rear legs. They performed numerous tests on the animals' ability to move as well as their reaction to pain and temperature. Throughout this process, they took blood samples to measure any changes in the levels of specific immune system molecules.
One of the more novel tests, developed by Allen, involved taking high-speed videotapes of the animals - those that received the procedure and those that did not - and analyzing step by step the particulars of the animals' gait. Specifically, they measured how the animals responded to the pressure of walking with an affected leg and how they shifted their weight in response.
"Following surgery, we noticed some novel signs of limping, characterized by changes in gait symmetry and the placement of more weight on the non-affected limb," Allen explained. "While some of our findings confirmed what others have suggested, our results were able to quantify the extent of the gait asymmetry, or limping, which could prove important as we evaluate different treatments."
Further studies are planned to test the effects of different IL-17 blockers on the mechanics of the animals' movement.
The research was support by funds from Zimmer Orthopedics, National Institutes of Health and a Pratt-Gardner Predoctoral Research Fellowship.
Other Duke members of the research team were Stephen So, Liufang Jing, Samuel Adams, Reinhard Schuh, Janet Huebner, Virginia Kraus, Allan Friedman and William Richardson.
Source:
Richard Merritt
Duke University
Sciatica is not a single disorder, but rather a diverse range of symptoms, such as numbness or pain from the lower back to the feet, radiating leg pain or difficulty in controlling the leg. It is often caused by compression, or pinching, of any of the five nerve roots that combine to make up the sciatic nerve. These roots are the parts of the nerve that pass through openings in the spine to the spinal cord.
Surgical simulation of nerve compression in rats was led by Mohammed Shamji, a neurosurgery resident and recent Ph.D. graduate working in the laboratory of senior researcher Lori Setton, professor of biomedical engineering and surgery at Duke's Pratt School of Engineering. Shamji and post-doctoral research fellow Kyle Allen observed that the animals' gait became asymmetric, and that they over-responded to temperature changes and touch in their limbs after the surgery.
They also found, for the first time, that the physical symptoms experienced by the affected animals seemed to be linked to an increase in levels of interleukin-17 (IL-17), a protein involved in regulating the inflammatory response. Elevated levels of IL-17 have already been implicated in such autoimmune diseases as rheumatoid arthritis and asthma.
"This finding suggests a possible role for immune system activation in contributing to symptoms of sciatica," said Shamji, now completing his neurosurgical residency at the Ottawa Hospital in Canada. "This offers new insight into the pathophysiology of the disease, and may also identify novel therapeutic targets to treat it."
The results of Shamji's and Allen's experiments were published online in the journal Spine.
"If immune system activation is involved, and it turns out to be an important part of the condition, it is possible that existing or new drugs that can block this immune response could offer relief to patients," Setton said. "This new model should help us find answers for a disorder that has few good treatments."
For their experiments, the researchers compressed a specific nerve root known as the dorsal root ganglia in the lumbar region of the spine, which simulated sciatica in one of the rear legs. They performed numerous tests on the animals' ability to move as well as their reaction to pain and temperature. Throughout this process, they took blood samples to measure any changes in the levels of specific immune system molecules.
One of the more novel tests, developed by Allen, involved taking high-speed videotapes of the animals - those that received the procedure and those that did not - and analyzing step by step the particulars of the animals' gait. Specifically, they measured how the animals responded to the pressure of walking with an affected leg and how they shifted their weight in response.
"Following surgery, we noticed some novel signs of limping, characterized by changes in gait symmetry and the placement of more weight on the non-affected limb," Allen explained. "While some of our findings confirmed what others have suggested, our results were able to quantify the extent of the gait asymmetry, or limping, which could prove important as we evaluate different treatments."
Further studies are planned to test the effects of different IL-17 blockers on the mechanics of the animals' movement.
The research was support by funds from Zimmer Orthopedics, National Institutes of Health and a Pratt-Gardner Predoctoral Research Fellowship.
Other Duke members of the research team were Stephen So, Liufang Jing, Samuel Adams, Reinhard Schuh, Janet Huebner, Virginia Kraus, Allan Friedman and William Richardson.
Source:
Richard Merritt
Duke University
среда, 15 июня 2011 г.
Do UK GPs Need Educating On The Psychosocial Management Of Back Pain
Researchers from Bournemouth, UK set out to identify whether there were any inconsistencies or deficits in the knowledge and understanding of local general practitioners (GPs) about the management of lower back pain - both physically and psychosocially. The intent was to inform the development of new and improved educational tools and interventions designed to improve confidence and clinical effectiveness in treating this group of patients.
Twenty-one general practitioners from the Somerset area in the UK initially took part in a short semi-structured telephone interview about the management of back pain. The responses from these first phase interviews helped develop the structure of more in-depth focus groups that took place two months later with the same group. Both discussions were transcribed, coded and quantitatively analysed for consistent themes and specific issues.
On review of the information provided by this group, five consistent areas of discussion evolved: the patient-practitioner relationship; feelings of the patient; time; education (of both patients and professionals) and resources. Psychosocial issues were rarely mentioned.
The researchers conclude by recognising how complicated and frustrating lower back pain consultations can be for physicians, but they also emphasise the value of improved GP education regarding the psychosocial aspects of lower back pain and how a better understanding of these complications might substantially improve quality of care.
paineuropenewswire
Twenty-one general practitioners from the Somerset area in the UK initially took part in a short semi-structured telephone interview about the management of back pain. The responses from these first phase interviews helped develop the structure of more in-depth focus groups that took place two months later with the same group. Both discussions were transcribed, coded and quantitatively analysed for consistent themes and specific issues.
On review of the information provided by this group, five consistent areas of discussion evolved: the patient-practitioner relationship; feelings of the patient; time; education (of both patients and professionals) and resources. Psychosocial issues were rarely mentioned.
The researchers conclude by recognising how complicated and frustrating lower back pain consultations can be for physicians, but they also emphasise the value of improved GP education regarding the psychosocial aspects of lower back pain and how a better understanding of these complications might substantially improve quality of care.
paineuropenewswire
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