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It is the first large phase II international multicentre clinical trial to determine the safety of a consensus treatment protocol established by the International Mesenchymal Stem Cells Transplantation Study Group to obtain information on its effectiveness on multiple sclerosis patients. Promising results are that so far the treatment appears safe, without adverse side effects.
Multiple Sclerosis - Italians Lead Clinical Trial Testing Safety and Effectiveness of Stem Cell Transplantation MS Patients
(ANSA) – Boston, September 9 – Mesenchymal stem cell therapy to treat multiple sclerosis so far appears safe and without side effects, according to data released Tuesday and obtained through clinical trials on patients as part of the international Mesems project coordinated by University of Genoa neurologist Antonio Uccelli.
The results were announced ahead of the World Congress on Treatment and Research in Multiple Sclerosis opening in Boston Wednesday through Saturday. The Mesems project involves researchers from nine countries – Italy, Spain, France, Britain, Sweden, Denmark, Switzerland, Canada and Australia.
It is the first large phase II international multicentre clinical trial to determine the safety of a consensus treatment protocol established by the International Mesenchymal Stem Cells Transplantation Study Group to obtain information on its effectiveness on multiple sclerosis patients.
So far, 81 patients have been involved in the project – half of the 160 needed for the whole clinical trial. About 73 – or 90% of those involved in blind testing – were given at least one injection with mesenchymal therapy or got a placebo while 51 – or 63% – were given both injections and 27 – 33% – completed the study.
“The promising result is that so far none of these 27 people have suffered significant adverse events, which means that, so far, the treatment appears to be safe”, said Uccelli. The neurologist warned that “caution is necessary” and that the effectiveness of the therapy can only be determined once the study is completed in 2016.
Uccelli however added that preliminary studies on animals have persuaded researchers that mesenchymal stem cells “can halt inflammation on the central nervous system and probably succeed in protecting nervous tissue, even repairing it where damage is minor”. Out of the 81 patients recruited so far, “28 are Italian and 10 of them have completed the study”, Uccelli said, adding that all patients over the past year did relatively well except for one who was treated with placebo.
The neurologist expressed the hope that “data in 2016 will give final confirmation that the therapy is effective so we can take the subsequent step with a larger phase III study aimed at demonstrating the role of stem cells as neurorepairers”. Meanwhile Genoa’s bioethics committee has approved a two-year extension of the project, which will be called Mesems Plus, “to verify, beyond the year of observation provided for by Mesems, the long-term safety of treatments in the study and the potential insurgence of adverse events in all those treated”, said Uccelli.
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A study last week showed statin use increases the risk of diabetes by 46 per cent, and those who take the cholesterol-lowering drugs are more than twice as likely to develop Parkinson’s disease in later life than those who do not.The Parkinson’s research carried out over 20 years suggests cholesterol may have a vital role in protecting the brain and nervous system.The findings have alarmed experts who say if applied to the number of Britons deemed eligible for statins it could equate to 150,000 extra patients with Parkinson’s. The work has also fuelled concerns that statins, now recommended for up to half the adult population over 50 by government drug policy adviser the National Institute for Health and Care Excellence, may be doing many patients more harm than good.
EXCLUSIVE: Parkinson's link to statins: Calls to end widespread use of the drug
PLANS for the mass prescription of statins should be shelved after a study linked the drug to Parkinson’s disease, an expert last night warned.
Dr Kailash Chand, deputy chairman of the British Medical Association, was speaking following research which found those who take the cholesterol-lowering drugs are more than twice as likely to develop Parkinson’s disease in later life than those who do not.
A study last week showed statin use increases the risk of diabetes by 46 per cent.
It has led to calls to end to the widespread use of the drugs.
The Parkinson’s research carried out over 20 years, and involving nearly 16,000 people, suggests cholesterol may have a vital role in protecting the brain and nervous system.
The findings have alarmed experts who say if applied to the number of Britons deemed eligible for statins it could equate to 150,000 extra patients with Parkinson’s, a central nervous system disorder affecting one in 350 mostly older people.
The work has also fuelled concerns that statins, now recommended for up to half the adult population over 50 by government drug policy adviser the National Institute for Health and Care Excellence, may be doing many patients more harm than good.
Doctors used to prescribe the drugs only to those who had a 30 per cent or greater risk of suffering a heart attack within a decade, but this was lowered to 20 per cent in 2005.
A 10-year plan has been introduced to reduce this further and include low-risk patients who have just a 10 per cent chance of a heart attack within a decade.
Nice believes this could save thousands of lives.
Other studies have shown a link between the cholesterol-lowering drugs and potentially disabling side effects including cataracts, diabetes, muscle pains, fatigue and memory loss.
Researchers warn that the mass roll-out of statins leaves 150,000 people at risk
Dr Chand, who suffered debilitating muscle pains while taking statins, said of the Parkinson’s research:
“This research has been done over a considerable amount of time and on a considerable number of people and it is very worrying.”
Speaking in a personal capacity, he added:
"The risks of side-effects of these drugs are far greater than any potential benefits and it is high time these drugs were restricted in the low-risk population" - Dr Kailash Chand
Dr Xuemei Huang, who led the research, recently published in the journal of Movement Disorders, expressed concerns about the widespread prescription of statins.
The professor of neurology at Penn State College of Medicine in Pennsylvania said:
“If we blanket prescribe statins to people we could be creating a huge population of people with neurological problems.
“Does mother nature create cholesterol for a reason?
"I think doctors are over-enamoured with statins and think it is a cure-all.
“But the body is not just for the heart, it is also for the brain.
"It is potentially harmful for these drugs to be given out so widely and randomly.”
Last year leading doctors’ magazine Pulse revealed two-thirds of GPs are disregarding Nice advice to offer statins to more patients. via
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In this Good Morning Texas segment, Dr. Bill Johnson explains how SVF Stem Cell Therapy can be used for Neuropathy, MS, ALS, knee replacement, and shoulder replacement. A full transcript of the conversation is listed below.
SVF Stem Cell Therapy For Neuropathy, MS, ALS, Knee Replacement, Shoulder Replacement
Full Transcript
HOST: Well, we often hear about stem cell therapy in the news and in magazines. We see this word used a lot. But what’s really happening to advance this type of therapy?
Well, Dr. Bill Johnson of Innovations Medical has just returned from a conference. He is here to tell us about some of the latest developments, and some of them are really exciting, Dr. J.
DR. J: Really some exciting things going on. We’re talking about using your own fat to get your own stem cells and then giving them back to you for therapeutic reasons – to fix things that we’ve not been able to fix in the past – and one of the really piece of the update is there’s more and more research showing that using cells that come from fat are effective in this. That’s important because probably the most common question we get is why we’re not using bone marrow cells.
HOST: Okay. Yeah, right.
DR. J: And the reason we don’t like bone marrow is fat’s easier to get and we can get much larger numbers. With bone marrow, you typically have to culture the cells to get enough to use, and when you do that, most people have to go outside the country to use them. When we use your fat, we don’t have to do that, we don’t have to culture them. And, with studies showing that it’s effective, we’re really feeling better and better about fat all the time.
HOST: Okay. This is actually a really huge advancement that you’re bringing to us today. So, once you have those stem cells from fat – not from bone marrow – how important is it how we use them?
DR. J: Well, the process of getting the cells out of the fat has become really standardized. We’re getting 50 to 100 million stem cells every time we do it. And so, it’s no longer a mystery, there’s no longer a lot of work going into how to get the cells. Where all the work is coming is how do we use the cells once we have them and this became more and more apparent that how we use them is critical in the response we get.
Just as an example, a year ago, when we first started, if someone came in with knee problems, needing knee replacement, we’re going to try and help them. We gave all the stem cells into the knee. Now, we give part of the stems cells into the knee and part of the stem cells in the vein because it’s been shown that, when we use both, we get a more consistent response, a more complete response. So, we’re learning more and more that how we deliver the cells is really critical in how well they work.
HOST: Okay. So, can patients do anything before the deployment to help out that response?
DR. J: Well, that’s a question that’s more and more coming up. How do we make the response better? And one of the really interesting things that’s come from that is that we need a little inflammation to really make this effective and we’ve got an animation here that shows why because, when we cut ourselves or cut our finger, what happens is the damaged cells release growth factors and the growth factors are what call the stem cells in and stimulate them to multiply and do the healing.
So, because of that, if, for instance, you have an arthritic joint and you’re on an anti-inflammatory, we now realize that we need to stop that a few days ahead of time so we’ve got a little inflammation area and that’s going to enhance the ability of the stem cells to work. We’re also starting to use some techniques like Acoustic Wave Therapy which we’ve used before for cellulite and other things. We can produce a little bit of inflammation with that and, again, producing that little bit of inflammation really enhances the ability of the stem cells to target where we’re going and then do what we want them to do when they get there.
HOST: Okay. So, you’re hopeful that this is going to help with so many different diseases. In fact, there’s been some good advancements that suggest ALS may benefit from it.
DR. J: Yeah, I think one of the very most exciting advancements is we now have a neurosurgeon out in California that’s placing a port that goes into the cerebral spinal fluid right around the brain. It’s an easy little out-patient procedure. Actually, it only takes about ten minutes to do. And that allows us to inject the stem cells directly into the fluid around the brain.
Right now, we’re doing it just as a target. By next year, we should be able to use this for patients with ALS. There’s some real hope for all these people that are getting there. The ice bucket challenge may really help to get some real hope for stem cell work on ALS. There’s some real good hope for multiple sclerosis Alzheimer’s disease, Parkinson’s disease – a lot of these neurologic disorders that previously we’ve had very few ways of making a real difference.
HOST: Okay. This is just a year that you’ve been bringing this to GMT and these advancements are really exciting. So, obviously, one more year is going to yield hopefully even better results and better after-stories as well, right?
DR. J: We’re really, really excited about it, and with all these new changes, from now till the end of September, we’re going to go back to our introductory price. We’d let prices go up and we’re going to go back to our original price in September because we now know some more that we didn’t know a year ago.
HOST: That’s great. Dr. J, thanks for the update today.
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Many have become familiarized with Lou Gehrig disease, also know as ALS (Amyotrophic Lateral Sclerosis), with the recent popularity of "The ALS Ice Bucket Challenge." Years before there was the Ice Bucket Challenge Israeli biotech company, BrainStorm, has been working in the background, developing a new and effective treatment untilizing adult stem cell therapy called NurOwn. The name, refers to the use of patient's own stem cells as the base of treatment. This first-of-its-kind technology essentially takes the patients' own mesenchymal stem cells from their bone marrow. In an interview, BrainStorm President, stated that the purpose of this therapy is to 'regenerate the cells that have not yet died, to keep the yet-healthy cells well, and hopefully to also regenerate the new, healthy cells, with the goal of stopping progression…if used immediately following diagnoses, it may stop all progression, and perhaps even cure the disease'.
Israel's ALS Research in Action
Many have only recently become familiarized with Lou Gehrig's disease, also know as ALS (Amyotrophic Lateral Sclerosis), with the recent popularity of "The ALS Ice Bucket Challenge," which has taken social media by storm, and succeeded in raising millions of dollars for research - specifically, a comprehensive study of the human genome to determine genetic factors in onset and progression of this degenerative disease. What you may not have heard, however, is that before there was the Ice Bucket Challenge to chill the spine, warm the heart, and open the wallet, Israeli biotech company, BrainStorm, has been tirelessly working in the background for years, developing a new and effective treatment for ALS (as well as other debilitating neurodegenerative diseases such as Multiple Sclerosis and Parkinson's disease) using adult stem cells, and the results will astound you!
According to the ALS Association, ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. Motor neurons reach from the brain to the spinal cord and from the spinal cord to the muscles throughout the body. The progressive degeneration of the motor neurons in ALS eventually leads to their death. When the motor neurons die, the ability of the brain to initiate and control muscle movement is lost. With voluntary muscle action progressively affected, patients in the later stages of the disease may become totally paralyzed.
The average life expectancy for those diagnosed with ALS is about two to five years.
Despite a limited number of medications to improve quality of life and delay deterioration from the disease, the average life expectancy for those diagnosed with ALS is about two to five years. This means that time is of the utmost essence for ALS patients from the time of diagnoses. And finally, hope is beginning to materialize in the research of BrainStorm, an Israeli biotechnology company that is the frontrunner of adult stem cell research.
At Hadassah Medical Center in Jerusalem, BrainStorm has developed an adult stem cell therapy called NurOwn. In this case, the secret truly does lie in the name, referring to the patient's own stem cells as the base of treatment. This first-of-its-kind technology essentially takes the patients' own mesenchymal stem cells from their bone marrow, and treats them with certain chemicals which cause them to multiply and become neuron-supporting cells. These "upgraded" cells are then transplanted back into the patients near the site of damage, in the spine and/or muscles (depending on the disease). The newly implanted cells trigger nerve growth in the areas of implantation, promoting motor neuron growth, and the reestablishment of nerve muscle interaction. This innovative new method of using adult stem cells, completely bypasses all risk of cell rejection, as the implanted cells are, in fact, the patient's own; the treatment also masterfully absolves itself of all moral conflict involved in the much debated field of stem cell research and treatment, as the stem cells are adult stem cells derived from said patient.
This innovative new method of using adult stem cells, completely bypasses all risk of cell rejection
(photo credit: © BrainStorm Cell Therapeutics)
Clinical Trials in Israel declared a success
In 2014, BrainStorm successfully completed a Phase IIa dose-escalating trial with NurOwn in patients with ALS. The trial, which began in 2012, was overseen by Professor Dimitrios Karussis, a neurologist at Hadassah Medical Center. This Phase was designed to evaluate the safety and preliminary efficiency of the treatment. The trial participants received combined intramuscular and intrathecal administration of NurOwn cells in three cohorts with increasing doses. They were followed for six months after transplantation.
From among patients given this therapy was Rabbi Rafael Shmulevitz, who had been given a prognosis of two to four years to live. By the time he began BrainStorm's treatment he had lost the ability to walk and speak clearly. According to Karussis, “Within a few weeks following injection with NurOwn cells, the patient showed dramatic improvement in a variety of functions including breathing, speech, walking, muscular strength, and overall well-being.” Just six months following the treatment, Israelis watched the news in awe as Shmulevitz began speaking and walking once more. Currently, as of most recent reports, Rabbi Shmulevitz is alive and well, with his most drastic improvement having taken place in the beginning of the treatment.
While Karussis was not quick to draw scientific conclusion based on one patient, he did find the results to be very encouraging. When asked in an interview with Channel 2 News if he thought this was a breakthrough that will lead to a cure for ALS, Karussis answered that while it was still soon to be making such general statements, he believed that "we are in the first stages of something new and revolutionary."
"...we are in the first stages of something new and revolutionary."
Fast forward two years later to present day: BrainStorm has already received FDA approval for NurOwn to begin clinical trials in the United Stated. In June 2014 BrainStorm entered into a Memorandum of Understanding with the University of Massachusetts Medical School and Massachusetts General Hospital to begin ALS human clinical trials at these institutions that consist of randomized, double-blind, placebo-controlled multi-center studies to further determine the safety and efficiency of the treatment.
In an interview, BrainStorm President Chaim Lebovits, stated that the purpose of this therapy is to 'regenerate the cells that have not yet died, to keep the yet-healthy cells well, and hopefully to also regenerate the new, healthy cells, with the goal of stopping progression…if used immediately following diagnoses, it may stop all progression, and perhaps even cure the disease'. The outlook is bright for the future of the adult stem cell research field, and could very well mean a revolution in the way we treat disease in the not-so-distant-and-ever-approaching-future.
Adult stem cell research could very well mean a revolution in the way we begin to treat disease.
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Newswise Researchers at the University of California, in partnership with ViaCyte, Inc., a biotechnology firm specializing in regenerative medicine, have launched the first-ever human Phase I/II clinical trial of a stem cell-derived therapy for patients with Type 1 diabetes. By implanting specially encapsulated stem cell-derived cells under the skin of patients, its believed they will mature into pancreatic beta cells able to produce a continuous supply of needed insulin. The hope is that this approach will ultimately transform the way individuals with Type 1 diabetes manage their disease by providing an alternative source of insulin-producing cells, potentially freeing them from daily insulin injections or external pumps.
CLINICAL TRIAL TO TEST SAFETY OF STEM CELL-DERIVED THERAPY FOR TYPE 1 DIABETES
September 10, 2014
University of California, San Diego Health Sciences
The trial will assess the safety and efficacy of a new investigational drug called VC-01, which was recently approved for testing by the U.S. Food and Drug Administration. The 2-year trial will involve four to six testing sites, the first being at UC San Diego, and will recruit approximately 40 study participants.
The goal, first and foremost, of this unprecedented human trial is to evaluate the safety, tolerability and efficacy of various doses of VC-01 among patients with type 1 diabetes mellitus, said principal investigator Robert R. Henry, MD, professor of medicine in the Division of Endocrinology and Metabolism at UC San Diego and chief of the Section of Endocrinology, Metabolism & Diabetes at the Veterans Affairs San Diego Healthcare System. We will be implanting specially encapsulated stem cell-derived cells under the skin of patients where its believed they will mature into pancreatic beta cells able to produce a continuous supply of needed insulin. Previous tests in animals showed promising results. We now need to determine that this approach is safe in people.
Development and testing of VC-01 is funded, in part, by the California Institute for Regenerative Medicine, the states stem cell agency, the UC San Diego Sanford Stem Cell Clinical Center and JDRF, the leading research and advocacy organization funding type 1 diabetes research.
Type 1 diabetes mellitus is a life-threatening chronic condition in which the pancreas produces little or no insulin, a hormone needed to allow glucose to enter cells to produce energy. It is typically diagnosed during childhood or adolescence, though it can also begin in adults. Though far less common than Type 2 diabetes, which occurs when the body becomes resistant to insulin, Type 1 may affect up to 3 million Americans, according to the JDRF. Among Americans age 20 and younger, prevalence rose 23 percent between 2000 and 2009 and continues to rise. Currently, there is no cure. Standard treatment involves daily injections of insulin and rigorous management of diet and lifestyle.
Phase I/II clinical trials are designed to assess basic safety and efficacy of therapies never before tested in humans, uncovering unforeseen risks or complications. Unpredictable outcomes are possible. Such testing is essential to ensure that the new therapy is developed responsibly with appropriate management of risks that all medical treatments may present.
This is not yet a cure for diabetes, said Henry. The hope, nonetheless, is that this approach will ultimately transform the way individuals with Type 1 diabetes manage their disease by providing an alternative source of insulin-producing cells, potentially freeing them from daily insulin injections or external pumps.
This clinical trial at UC San Diego Health System was launched and supported by the UC San Diego Sanford Stem Cell Clinical Center. The Center was recently created to advance leading-edge stem cell medicine and science, protect and counsel patients, and accelerate innovative stem cell research into patient diagnostics and therapy.via
Would Stem Cells Be Right For Me?
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