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Public release date: 17-May-2012 [ | E-mail | Share ]

Contact: Kerry Noble k.noble@qmul.ac.uk 44-207-882-7943 Queen Mary, University of London

Pregnant women, including those who are obese or overweight, should be encouraged to minimise weight gain through diet, according to major new research from Queen Mary, University of London.

Piling on excess weight during pregnancy increases the risk of complications for pregnant women but doctors have been cautious in advising women on ways to manage weight for fear of any adverse effect on mother or baby.

However, the new study published in the BMJ shows that following a healthy diet, overseen by health professionals, stems excess weight gain in pregnancy and reduces the risk of pregnancy complications such as pre-eclampsia, diabetes, high blood pressure and early delivery.

Half the UK population are either overweight or obese and the rates are rising. Around a third of women gain more than the recommended amount during pregnancy.

Previous research has linked obesity during pregnancy with an increase in a variety of risks including high blood pressure, diabetes, miscarriage, birth defects, blood clots, pre-eclampsia, and even maternal and infant deaths.

The new research, which brings together the results of 44 separate studies, is the largest of its kind and includes data on more than 7,000 women. It was commissioned and funded by the NIHR’s Health Technology Assessment programme.

The researchers investigated the effect of diet, exercise, or a combination of the two. They looked at how much weight women gained throughout pregnancy and whether mother or child suffered from any complications.

Although all three methods reduced the mother’s weight gain, diet had the greatest effect with an average reduction of nearly four kilograms. Exercise only resulted in an average reduction in weight gain of just 0.7kg. A combination of diet and exercise only produced and average reduction of one kilogram.

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Weight in pregnancy best controlled by diet, study shows

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Dieting 'safe' for pregnant women

By Jenny Hope

PUBLISHED: 18:22 EST, 17 May 2012 | UPDATED: 04:36 EST, 18 May 2012

Risks: According to research women who pile on the pounds during pregnancy could risk health issues (picture posed by model)

Pregnant women should watch the calories because eating for two could increase the risk of complications, warn researchers.

They found that mothers who minimised weight gain through a healthy, calorie-controlled diet were less likely to suffer life-threatening pre-eclampsia.

Researchers from Queen Mary, University of London, said helping women with weight management methods had no ill-effects on their babies and prevented complications including diabetes, high blood pressure and premature birth.

Controlled diets reduced weight gain during pregnancy by nearly half a stone on average when compared to women who were not given advice.

Their study, published on bmj.com, also claimed that eating for two during pregnancy could leave women saddled with the extra pounds for life.

Around 15 per cent of British women are obese when expecting a child up from 7 per cent 20 years ago.

Doctors have warned that babies born to overweight women are at greater risk in later life of diabetes and obesity themselves.

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Eating for two? Piling on the pounds during pregnancy can increase risk of diabetes and high blood pressure

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Weight loss during pregnancy helps mom and baby

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Pregnancy weight control 'helpful'

Editor’s Choice Main Category: Pregnancy / Obstetrics Also Included In: Nutrition / Diet Article Date: 18 May 2012 – 9:00 PDT

Current ratings for: ‘Weight Management And Dieting During Pregnancy Is Beneficial’

Pregnant women who are overweight or obese can have serious health risks including high blood pressure, pre-eclampsia, diabetes and premature birth, but there is good news. A study published today on bmj.com shows that these risks can be mitigated by following a healthy calorie controlled diet over the course of the pregnancy. With the infamous cravings, this might prove more difficult in practice, nonetheless the benefits are proven.

The article outlines quite shocking figures, showing that more than half the women in the UK are are overweight or obese, while more than 40% of women in the US and Europe gain more than the recommended weight while pregnant. While some girls like to assume it’s their time to relax about their weight and diet and give into the cravings, excessive weight gain during pregnancy can cause serious health problems.

On the other hand, women who are pregnant are generally receptive to health issues, with many quitting smoking and drinking and being concerned about their diet and health, to do everything possible not only to give their baby the best start in life, but also protect their own health during the pregnancy. It’s said that pregnancy is the only time a person goes to hospital without being ill, but none the less it is a delicate time for a mother to be.

The researchers, led by Dr Shakila Thangaratinam from Queen Mary, University of London, investigated looked at both of diet and exercise, or a combination of both, to assess how that could factor into weight gain during pregnancy. They also wanted to see if dieting and calorie control would have any adverse effects on mother or baby.

The study is quite impressive, with 44 randomized controlled trials being put in place to involving some 7,000 women. The design of the study was taken into account to minimize bias. Diet was clearly the most effective, with a 4kg reduction in weight gain, compared with only 0.7kg for exercise and 1kg for the combination of both. Diet also prevented the most complications with blood pressure, pre-eclampsia, diabetes, and premature birth being reduced, but the overall evidence rating was low to very low.

While the authors conclude that dietary and lifestyle interventions do not adversely affect the baby’s birth weight and can be positive for both mother and baby, they take note of risk factors, such as mother’s age, ethnicity and socioeconomic status. At the same time, accompanying editorial from experts at St Thomas’ Hospital in London, say there is not yet sufficient evidence to support any particular intervention.

Lucilla Poston and Lucy Chappell say they welcome the study, but does not go as far as to provide evidence needed for the National Institute for Health and Clinical Excellence (NICE) to reassess the guidelines for weight management in pregnancy. They point to the future though, and mention several ongoing trials that they hope will enable a better understanding of the best types of interventions for overweight and obese women curing pregnancy.

Written by Rupert Shepherd Copyright: Medical News Today Not to be reproduced without permission of Medical News Today

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Weight Management And Dieting During Pregnancy Is Beneficial

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Pregnancy weight control helpful: Study

Public release date: 17-May-2012 [ | E-mail | Share ]

Contact: Emma Dickinson edickinson@bmjgroup.com 44-207-383-6529 BMJ-British Medical Journal

For pregnant women, including those who are overweight and obese, following a healthy calorie controlled diet during pregnancy is safe and can reduce the risk of serious complications such as pre-eclampsia, diabetes and premature birth, finds a study published on bmj.com today.

In the UK, more than half the women of reproductive age are overweight or obese, and across Europe and the US, up to 40% of women gain more than the recommended weight in pregnancy. Excessive weight gain during pregnancy is associated with a number of serious health problems.

Pregnancy is thought to be an ideal time for health professionals to discuss weight management as mothers are motivated to make changes that will benefit themselves and their baby.

So a team of researchers, led by Dr Shakila Thangaratinam from Queen Mary, University of London, investigated the effects of diet, exercise, or a combination of the two on weight gain during pregnancy and any adverse effects on mother or baby.

They analysed the results of 44 randomised controlled trials involving over 7,000 women. Study design and quality were taken into account to minimise bias.

Weight management interventions in pregnancy were effective in reducing weight gain in the mother. Dietary intervention resulted in the largest average reduction in weight gain (almost 4 kg) compared with just 0.7 kg for exercise and 1 kg for a combination of the two. Diet also offered the most benefit in preventing pregnancy complications such as pre-eclampsia, diabetes, high blood pressure and premature birth.

However, the authors stress that the overall evidence rating was low to very low for these important outcomes.

Importantly, the results showed that interventions are safe and do not adversely affect the baby’s weight. The authors conclude that dietary and lifestyle interventions in pregnancy improve outcomes for both mother and baby, but acknowledge the lack of data on risk factors such as age, ethnicity and socioeconomic status.

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Weight management in pregnancy with diet is beneficial and safe and can reduce complications

Osiris Therapeutics Inc said on Thursday that Canadian health regulators have approved its treatment for acute graft-versus host disease in children, making it the first stem cell drug to be approved for a systemic disease anywhere in the world.

Osiris shares rose 14 percent to $6.00 in extended trading after the news was announced.

Graft versus host disease (GvHD) is a potentially deadly complication from a bone marrow transplant, when newly implanted cells attack the patient’s body. Symptoms range from abdominal pain and skin rash to hair loss, hepatitis, lung and digestive tract disorders, jaundice and vomiting.

The disease kills up to 80 percent of children affected, Osiris said. To date there have been no approved treatments for the disease. Canadian authorities approved the therapy, Prochymal, for use in children who have failed to respond to steroids.

Prochymal was approved with the condition that Osiris carry out further testing after it reaches the market. C. Randal Mills, the company’s chief executive, said in an interview that could take three to four years.

Some investment analysts have been skeptical about Prochymal’s future. In 2009, two late-stage clinical trials failed to show the drug was more effective overall than a placebo in treating the disease, though it showed promise in certain subgroups of patients.

Since then, the company has mined data from all its clinical trials to show that in patients with severe refractory acute GvHD — those who have more or less failed all other therapies — Prochymal demonstrated a clinically meaningful response at 28 days after therapy began in 61-64 percent of patients.

In addition, treatment with Prochymal resulted in a statistically significant improvement in survival when compared with a historical control population of pediatric patients with refractory GvHD.

The Canadian authorities approved the drug on the basis of that data, the company said.

FDA submission this year

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First stem cell drug approved for systemic disease treatment

Toni Clarke BOSTON Globe and Mail Update Published Friday, May. 18, 2012 12:38PM EDT Last updated Friday, May. 18, 2012 12:56PM EDT

Osiris Therapeutics Inc. OSIR-Q said on Thursday that Canadian health regulators have approved its treatment for acute graft-versus host disease in children, making it the first stem cell drug to be approved for a systemic disease anywhere in the world.

Osiris shares rose 14 per cent to $6.00 in extended trading after the news was announced.

Graft versus host disease (GvHD) is a potentially deadly complication from a bone marrow transplant, when newly implanted cells attack the patient’s body. Symptoms range from abdominal pain and skin rash to hair loss, hepatitis, lung and digestive tract disorders, jaundice and vomiting.

The disease kills up to 80 per cent of children affected, Osiris said. To date there have been no approved treatments for the disease. Canadian authorities approved the therapy, Prochymal, for use in children who have failed to respond to steroids.

Prochymal was approved with the condition that Osiris carry out further testing after it reaches the market. C. Randal Mills, the company’s chief executive, said in an interview that could take three to four years.

Some investment analysts have been skeptical about Prochymal’s future. In 2009, two late-stage clinical trials failed to show the drug was more effective overall than a placebo in treating the disease, though it showed promise in certain subgroups of patients.

Since then, the company has mined data from all its clinical trials to show that in patients with severe refractory acute GvHD those who have more or less failed all other therapies Prochymal demonstrated a clinically meaningful response at 28 days after therapy began in 61-64 per cent of patients.

In addition, treatment with Prochymal resulted in a statistically significant improvement in survival when compared with a historical control population of pediatric patients with refractory GvHD.

The Canadian authorities approved the drug on the basis of that data, the company said.

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Prochymal approval makes Canada first country to OK stem cell therapy

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Indian clinic's stem cell therapy real?

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Osiris stem cell therapy approved in Canada

By Meg Tirrell – 2012-05-18T20:13:19Z

Osiris Therapeutics Inc. (OSIR) rose after the company said it won the worlds first approval for a stem- cell drug, gaining clearance in Canada to sell Prochymal for a disease that can attack patients who received bone-marrow transplants.

Osiris climbed 5.5 percent to $5.55 at 4 p.m. New York time. The shares have lost 24 percent in the last 12 months.

Prochymal was approved for the treatment of acute graft versus host disease in children for whom steroids havent worked, the Columbia, Maryland-based company said yesterday in a statement. Steroids have a 30 percent to 50 percent success rate, and severe GvHD can be fatal in 80 percent of cases, according to the company.

The therapy uses mesenchymal stem cells derived from bone marrow that can take on different forms to combat the immune reaction that causes patients to literally peel out of their skin and shed their intestinal lining, Osiris Chief Executive Officer Randal Mills said in a telephone interview. The disease has no equal.

The company hasnt sought approval for this indication in the U.S., where regulators asked for more data before considering whether to allow sales of the drug, Mills said. Prochymal is used in eight countries, including the U.S., on an expanded-access program basis, which allows patients to receive experimental medicines without participating in clinical trials.

This is the first regulatory approval of a stem-cell drug — where the active ingredient of the drug is a stem cell — in the world, Mills said. Its a huge deal for us and a huge deal for the entire field of stem-cell therapy.

Osiris shares declined from an all-time high of $28.56 in 2007 as the biotechnology company faced clinical setbacks, including two studies in 2009 that failed to show statistical improvement of Prochymal versus placebo.

The Canadian approval was based on data showing a clinically meaningful response 28 days after starting therapy for 61 percent to 64 percent of patients treated, Osiris said in the statement.

Prochymal may draw $16.7 million in revenue next year with Canadian approval, estimated Edward Tenthoff, an analyst with Piper Jaffray & Co., before the companys announcement. He said that while Prochymal would be the first stem-cell drug to receive approval, other regenerative products used for wound- healing that employ stem cells are already on the market, such as Carticel from Sanofis Genzyme unit.

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Osiris Wins Canadian Approval for First Stem-Cell Therapy

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Canada OKs Osiris drug; first stem cell therapy

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Osiris shares climb on stem-cell therapy approval

Osiris Therapeutics Inc says Canadian health regulators have approved its treatment for acute graft-versus host disease in children, making it the first stem cell drug to be approved for a systemic disease anywhere in the world.

Osiris shares rose 14 percent to $6.00 in extended trading after the news was announced.

Graft versus host disease (GvHD) is a potentially deadly complication from a bone marrow transplant, when newly implanted cells attack the patient’s body. Symptoms range from abdominal pain and skin rash to hair loss, hepatitis, lung and digestive tract disorders, jaundice and vomiting.

The disease kills up to 80 percent of children affected, Osiris said. To date there have been no approved treatments for the disease. Canadian authorities approved the therapy, Prochymal, for use in children who have failed to respond to steroids.

Prochymal was approved with the condition that Osiris carry out further testing after it reaches the market. C. Randal Mills, the company’s chief executive, said in an interview that could take three to four years.

Some investment analysts have been skeptical about Prochymal’s future. In 2009, two late-stage clinical trials failed to show the drug was more effective overall than a placebo in treating the disease, though it showed promise in certain subgroups of patients.

Since then, the company has mined data from all its clinical trials to show that in patients with severe refractory acute GvHD — those who have more or less failed all other therapies — Prochymal demonstrated a clinically meaningful response at 28 days after therapy began in 61-64 percent of patients.

In addition, treatment with Prochymal resulted in a statistically significant improvement in survival when compared with a historical control population of pediatric patients with refractory GvHD.

The Canadian authorities approved the drug on the basis of that data, the company said.

FDA SUBMISSION THIS YEAR

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Canada approves stem cell therapy

COLUMBIA, Md.–(BUSINESS WIRE)–

Osiris Therapeutics Inc. (NASDAQ:OSIR – News) announced today it has received market authorization from Health Canada to market its stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. The historic decision marks the worlds first regulatory approval of a manufactured stem cell product and the first therapy approved for GvHD a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected, many within just weeks of diagnosis.

“I am very proud of the leadership role Canada has taken in advancing stem cell therapy and particularly gratified that this historic decision benefits children who would otherwise have little hope,” said Andrew Daly, M.D., Clinical Associate Professor, Department of Medicine and Oncology at the University of Calgary, Canada and Principal Investigator in the phase 3 clinical program for Prochymal. “As a result of Health Canada’s comprehensive review, physicians now have an off-the-shelf stem cell therapy in their arsenal to fight GvHD. Much like the introduction of antibiotics in the late 1920′s, with stem cells we have now officially taken the first step into this new paradigm of medicine.”

Prochymal was authorized under Health Canada’s Notice of Compliance with conditions (NOC/c) pathway, which provides access to therapeutic products that address unmet medical conditions and which have demonstrated a favorable risk/benefit profile in clinical trials. Under the NOC/c pathway, the sponsor must agree to carry out confirmatory clinical testing.

Today is not only a great day for Osiris, but for everyone involved in the responsible development of stem cell therapies, said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. Most importantly, today is a great day for children and their families who bravely face this horrific disease. While today marks the first approval of a stem cell drug, now that the door has been opened, it will surely not be the last.

Health Canadas authorization was made following the recommendation of an independent expert advisory panel, commissioned to evaluate Prochymal’s safety and efficacy. In Canada, Prochymal is now authorized for the management of acute GvHD in children who fail to respond to steroids. The approval was based on the results from clinical studies evaluating Prochymal in patients with severe refractory acute GvHD. Prochymal demonstrated a clinically meaningful response at 28 days post initiation of therapy in 61-64 percent of patients treated. Furthermore, treatment with Prochymal resulted in a statistically significant improvement in survival when compared to a historical control population of pediatric patients with refractory GvHD (p=0.028). The survival benefit was most pronounced in patients with the most severe forms of GvHD. As a condition of approval, the clinical benefit of Prochymal will be further evaluated in a case matched confirmatory trial and all patients receiving Prochymal will be encouraged to participate in a registry that will monitor the long-term effects of the therapy.

Refractory GvHD is not just deadly to the patients it afflicts, but is devastating for the family, friends, and caregivers who watch helplessly as the disease progresses, said Joanne Kurtzberg, MD, Head of the Pediatric Bone Marrow Transplant Program at Duke University and Lead Investigator for Prochymal. “I have personally seen Prochymal reverse the debilitating effects of severe GvHD in many of my patients and now, after nearly two decades of research, the data demonstrating consistently high response rates, a strong safety profile and improved survival clearly support the use of Prochymal in the management of refractory GvHD.”

Prochymal is currently available in several countries, including the United States, under an Expanded Access Program (EAP). Prochymal will be commercially available in Canada later this year.

Today Osiris turns the promise of stem cell research into reality, delivering on decades of medical and scientific research, said Peter Friedli, Chairman and Co-founder of Osiris. It took 20 years of hard work and perseverance and I want to personally thank everyone involved for their dedication to this important mission.

In addition to the extensive intellectual property protection Osiris has around Prochymal, which includes 48 issued patents, Health Canada’s decision will also provide Prochymal with regulatory exclusivity within the territory. Canada affords eight years of exclusivity to Innovative Drugs such as Prochymal, and an additional six-month extension is available since it addresses a pediatric population.

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World's First Approved Stem Cell Drug; Osiris Receives Marketing Clearance from Health Canada for Prochymal

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Fifty Shades…Of Dysfunction

News – Friday, May 18, 2012 New program treats sleep and sex disorders

by Nick Veronin

The problem with these ads, according to one El Camino Hospital doctor, is that they are only offering treatment for one of two issues that are often connected. A recently launched program at El Camino’s campus in Los Gatos aims to address the link between sexual dysfunction and sleep disorders by treating both conditions simultaneously.

The Sleep Disorders Program will be the first one run by a major hospital in Silicon Valley to focus on the link, according to Dr. Edward Karpman, a urologist at El Camino.

“We don’t want to just give patients a pill,” Karpman said. “We want to get down to that root cause” which in the case of sexual issues such as erectile dysfunction is very often related to sleep apnea.

“There is a significant relationship between sleep disorders and many of the problems men face when they get older” related to sexual dysfunction, Karpman said.

Men are not the only ones who may suffer sexual side effects as a result of sleep apnea. According to 2011 study published in The Journal of Sexual Medicine, men and women with obstructive sleep apnea between the ages of 28 and 64 had significantly higher levels of sexual dysfunction than those in a similar group without the sleeping disorder, according to a Sleep Disorders Program press release.

It isn’t exactly clear why sleep disorders impact libido, Karpman said, but he offered a theory to which he ascribes.

The airway of someone with obstructive sleep apnea becomes partially or completely blocked. This not only causes the person to repeatedly wake up thus disturbing the natural sleep cycle it also deprives the body of oxygen.

“Oxygen is essential to every cell in the body,” Karpman explained. “If you deprive the brain of oxygen repetitively, it could cause a disturbance of the circadian rhythm and of hormone production in the brain.” This could, in theory, cause a cascade of hormone disruption and depletion, which would result in lower testosterone production in men, and ultimately, sexual dysfunction.

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New program treats sleep and sex disorders