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3 arrested on stem cell charges

Published: Dec. 28, 2011 at 10:47 PM

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SAN ANTONIO, Dec. 28 (UPI) -- The FBI said Wednesday it arrested three men for their alleged roles in an operation that made stem cells and sold them to sick people without federal approval.
A fourth suspect remained at large, the FBI said in a release posted on its Web site.
The suspects in custody were identified as Francisco Morales, 52, of Brownsville, Texas; Alberto Ramon, 48, of Del Rio, Texas; and Vincent Dammai, 40, of Mount Pleasant, S.C. Morales was arrested Dec. 22, while Ramon and Dammai were arrested Tuesday.
The FBI said an arrest warrant had been issued for Lawrence Stowe, 58, of Dallas, who remained at large.
"This investigation identified a scheme whereby the suffering and hopes of victims in extreme medical need were used and manipulated for personal profit," FBI Special Agent in Charge Cory Nelson said. "The predatory and opportunistic nature of the crimes alleged in this indictment mirrors images from science fiction."
Federal authorities allege the four conspired to commit mail fraud and unlawfully distributed stem cells derived from umbilical cord blood. Morales and the others are accused of manufacturing, distributing and using stems cells produced from umbilical cord blood to perform procedures not approved by the U.S. Food and Drug Administration, to treat people who have cancer, amytrophic lateral sclerosis, multiple sclerosis and other autoimmune diseases.
FDA approval is required before stem cells can be marketed to the public and used to treat incurable diseases. The FDA has not determined stem cells are safe and effective in treating these diseases.
The indictment alleges that from 2007 to 2010 Morales falsely portrayed himself as a doctor who operated a medical clinic named Rio Valley Medical Clinic in Brownsville. He allegedly would meet patients in the United States and then travel to Mexico to perform the stem cell procedures.
Stowe allegedly marketed, promoted and sold stem cells along with other drug and biological products that don't have FDA approval for the treatment of cancer, ALS, MS and Parkinson's disease. Stowe ran The Stowe Foundation and Stowe Biotherapy Inc.
Ramon, a licensed midwife who operated The Maternity Care Clinic in Del Rio, allegedly obtained umbilical cord blood from birth mothers who were his patients and sold it to Global Laboratories. The Scottsdale, Ariz., company then allegedly sold the tissue to Dammai, a professor of pathology and laboratory medicine in Charleston, who allegedly created stem cells later sold by Global Laboratories.

Read more: http://www.upi.com/Top_News/US/2011/12/28/3-arrested-on-stem-cell-charges/UPI-21691325130464/#ixzz1hx1vSyiz

STEM CELLS AND STROKES

A stroke is caused when blood flow to the brain is interrupted

When stroke patients do not receive immediate care the chances of suffering paralysis, disturbances to speech and impaired vision increase. A new stem cell therapy aims to reverse the effects a stroke has on the body.

 

At first glance, the sheep in the compound of Leipzig's faculty of veterinary medicine look like your ordinary sheep. But if you take a closer look, you see that parts of them have been sheared.

"We took cells from iliac crest and we can't run the risk of contamination," explained Johannes Boltze, head of the Department of Cell Therapy at Fraunhofer Institute for Cell Therapy and Immunology in Leipzig.

The sheep's bone marrow contains stem cells that can transform into a variety of types of cells and which form the basis for the new therapy researchers are putting to the test.

Scientists trigger strokes in sheep then inject stem cells into the animals

Scientists in Leipzig have already triggered a stroke in some of the sheep while others still await their fate. It's impossible to tell at first glance which of the sheep sufferedd a stroke.

"Just a couple days after the stroke, they don't feel the difference anymore," Boltze said. "The sheep is not impaired in its daily life."

Certain tests, however, can document the subsequent damage. The scientists examine their sheep in a nuclear spin and a positron emission tomography (PET).

And they run different behavioral tests, because the sheep's course of motions is impaired after a stroke - just as it is in humans. The scientists pull away one of the sheep's forelegs. A healthy sheep immediately corrects its stance in order to stand on all fours again. But sheep that had a stroke show a delayed response or don't react at all. 

Can stem cells alleviate damages caused by a stroke?

Testing of the researchers' treatment began on lab rats and has been extended to sheep. Shortly after a stroke, the researchers give the animal an injection of immune cells and stem cells. Rats without the injection were not able to balance on a small bar whereas treated rats ran back and forth without a problem.

Sheep serve as substantially better testing grounds. But the quite positive results at the beginning have become ever more infrequent since the scientists started to conduct blind studies in which scientists do not know whether a sheep was treated with a stem cell injection.

About 30,000 cells can die each second when blood vessels to the brain are clogged

"None of the scientists was deliberately altering the results, but your own expectations do have an impact," said Boltze. Now, the positive results have decreased, but the scientists hope that the remaining results are even more significant and can be easily transferred to the human body.  

Currently, tests have called for injecting stem cells of the same animal. The next step will be to transfer human cells into the sheep. At one of Fraunhofer's laboratories, Alexandra Stolzing tries to recover stem cells from human skin. The difficultly is that skin cells do not naturally have the ability to form other types of cells. In order to work as stem cells, they need to be forced to "forget" the transformation they underwent to become a specific cell type. They need to be reset to be able to transform into another type of cell, such as a nerve cell.

The reprogramming is a complicated process that is affected by a number of factors, including the age and condition of a cell and the medium in which the process is due to take place. The researchers have just begun to understand the details. It's an exciting process that could go beyond being beneficial for stroke research.

"I work in the field of ageing research and it's fascinating to me that a cell can be brought back to a state that can be considered young," Stolzing said.

Still a long way to go

The scientists are still working to understand exactly what influence the stem cells have on the body. They know so far that the cells don't wander to the brain, build new neurons and replace the impaired tissue. This process would take at least four weeks, but the positive results of the stem cell injection shows after about a week, said Boltze.

Clinical trials are underway in the United States and will begin in Germany soon

"We assume that the cells block certain secondary complications, affect inflammation and minimize cell death," Boltze said, adding that stem cell therapy could become an important part of stroke treatment plans. "Maybe in total the result will be slightly better as without the stem cells."

The key is still how fast the patient reaches a proper clinic so that the blood clot in the brain can quickly be dissolved. Boltze consistently gets requests from patients that he cannot meet both for ethical and medical reasons. Since the methods are still in animal trials, Boltze cannot use them on human patients, and there is no established way to transfer stem cells to humans within the short three-day window after a stroke that the tests require.

Scientists in the United States have already started the first clinical trials and others are set to begin in Germany in 2012. But even if all trials are successful, in will take at least 10 years until the stem cell therapy will be available. In any case, preventing a stroke is better than treating one, said Boltze.

"Medicines are not the best solution," Boltze said. "The best solution is a healthy lifestyle. Don't smoke, drink only a little alcohol and exercise. That's more beneficial than any stem cell."

Author: Claudia Ruby / sst

Editor: Sean Sinico

The Irish Times - Thursday, December 15, 2011

Overcoming stem cell research difficulties

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WILLIAM REVILLE

PROPONENTS OF human embryonic stem cell research (HESCR) pitched their case for support on the basis that it would lead to cures in the relatively near term for a wide range of devastating human diseases.

Many people who have serious ethical qualms about HESCR were persuaded to stay quiet and to pay a “relatively small ethical price” for this dazzling medical potential. But suddenly all has changed – HESCR has entered very stormy waters and prospects that this approach will achieve significant medical cures, even in the medium term, have dramatically diminished. The story is summarised by Andy Coghlan in New Scientis t on November 18th, 2011.

Embryonic stem cells are pluripotent – they can turn into any of the more than 200 cell types found in human tissues. These embryonic stem cells therefore have great theoretical potential to repair and regenerate failing human tissue, thereby curing a wide variety of human diseases. However, HESCR confronts ethical and technical difficulties.

Human embryos must be killed in order to obtain human embryonic stem cells, but many people believe that the human embryo has the inherent right not to be deliberately destroyed. Many others, of course, including many scientists, do not share this position.

Ethics aside, it has proven to be extremely difficult to reliably coax embryonic stem cells to develop along a chosen path. For example, if you introduce embryonic stem cells into ailing nervous tissue, hoping that the cells will develop into healthy nerves, there is a significant chance that the cells will instead develop into another tissue type or perhaps into a cancerous tumour.

As a result, progress with embryonic stem cells has been very slow. Not only have no medical cures come out of this research to date but almost no clinical trials of potential cures have resulted. The California-based Geron Corporation, the largest biotechnology company dealing with stem cells, launched a trial of human embryonic cell treatment of spinal cord injuries about a year ago, but pulled out of the trial in November in favour of continuing research on new cancer drugs. To my knowledge, there is only one remaining clinical trial worldwide involving HESCR.

Proponents of HESCR now emphasise the value of this research in the study of human development. This is fundamental or “blue skies” research, quite different to the applied medical research used before to sell HESCR to public and political audiences. However, exactly the same ethical objection applies as before – human embryos must be killed to obtain the embryonic stem cells.

The good news is that two other stem cell options are available to medicine. One approach uses induced pluripotent stem cells (IPSC) and the other approach uses adult stem cells (ASCs). In 2005 Shinya Yamanaka of Kyoto University discovered how to induce ordinary cells to change into embryonic-like stem cells with the pluripotent potential to generate a large range of body tissues. These IPSCs are acceptable to those who oppose HESCR on ethical grounds. However, just as in HESCR, much difficult work remains to be done to develop the medical potential of induced pluripotent stem cells.

Most adult tissues in the body have their ASCs, which are not pluripotent but multipotent – they have the capacity to change into a limited range of tissue types. However, they are relatively easy to prepare, they are predictable and unlikely to form tumours.

Research using ASCs has been underway for many years. Successful medical treatments have been developed and about 200 clinical trials using ASC treatments are underway worldwide. The Australian company Mesoblast is using injections of adult stem cells to develop treatments for diabetes, bone disease, heart attacks and eyes.

Adult stem cells are now clearly leading the way clinically in terms of success rate, trial numbers and commercial potential. Some medical success could still come from HESCR if companies decide to invest heavily and take the risk. Treatments based on the new IPSCs are the furthest from the clinic but a massive research effort is underway and we can expect rapid progress here.

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William Reville is a professor in the Biochemistry Department and public awareness of science officer at UCC. understandingscience.ucc.ie

Relief for stem cell transplant patients

Wednesday, November 30, 2011 - 17:50 in Health & Medicine

In a study that seems to pivot on a paradox, scientists at Harvard-affiliated Dana-Farber Cancer Institute have used an immune system stimulant as an immune system suppressor to treat a common, often debilitating side effect of donor stem cell transplantation in cancer patients.  The effect, in some cases, was profound. The phase 1 study, published in the Dec. 1 issue of the New England Journal of Medicine, involved allogeneic (donor) stem cell transplant patients with chronic graft-versus-host disease (GVHD), a multisystem inflammatory condition that arises when donor immune system cells launch an attack on a patient’s own tissues, leading to varied symptoms such as skin rash and thickened or scarred skin, lung inflammation, or hepatitis, among others.  The patients received once-daily injections of interleukin-2 (IL-2), a drug traditionally used to spur an immune system attack, but which, at low doses, investigators had reason to believe, could have the opposite effect in this case:...

Read the whole article on Harvard Science

More from Harvard Science

AUTISM AND STEM CELLS

A new study out of Harvard University, reported in Science, suggests that a transplant of stem cells into the brain may lead to future treatment for neural disorders, such as Autism and Parkinson's Disease, as well as spinal cord injuries and diseases, such as ALS. The researchers in the study focused on curbing obesity in mice, as it provides visual evidence as to whether the treatment was effective or not. Despite the focus on obesity, the study's results led the scientists to believe that this could potentially lead to further treatments for other diseases.

"[Researchers] investigated whether fetal neurons transplanted into a part of the mouse brain that does not normally produce new neurons of its own could repair an abnormal neural circuit. The recipients of the transplant treatment were genetically altered mice lacking the receptor for leptin, a hormone that regulates metabolism and body weight. In normal mice, leptin acts on neurons in a part of the brain called the hypothalamus, which regulates metabolism and other essential functions. But in the mutant mice, these neurons can't respond to leptin, and the mice become obese and diabetic. To see whether they could correct this defect, the researchers transplanted immature neurons taken from the hypothalami of fetal mice that had the normal leptin receptor gene into the same brain region of the obesity-prone mice.

Using electrodes to record the electrical activity of hypothalamic neurons, the researchers confirmed that the transplanted cells responded to leptin as expected and could communicate with the recipient mouse's own neurons. 'These newly incorporated neurons were in a sense acting as antennas for leptin and sending those signals into the brain.'"

AdvertisementThe implications of this study are staggering, namely that if researchers can pinpoint what neurons are specifically involved or responsible for the symptoms of a given neural disease, they may be able to introduce transplanted cells and guide their development, essentially repairing what has been damaged or what is malfunctioning. This runs counter to what scientists originally thought which was that one may simply infuse stem cells into an affected brain and the neural circuitry already present will know what to do, whereas in reality, stem cell therapies must be specifically selected and tailored for the affected area."We have used complex circuitry as a test case for whether precisely selected and controlled neuron transplants could rewire the brain. What we found is that these neurons not only turned into the right types of cells, but they sent signals to the recipient’s brain and received signals from the recipient’s brain. The next step for us is to ask parallel questions of other parts of the brain and spinal cord."

This study comes in light of the mulitude of other researchthat unequivocally determines that Autism is a neuralogical disease in origin and in manifestation. The hope for treatment and possible cure therefore lies in addressing the neural deficits specifically, such as with stem cell therapies, rather than special diets and avoidance of vaccines.

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Diabetes fight should be a priority

Print | Comments ()Posted by Marjorie Pritchard  November 18, 2011 02:00 PM

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John L. Brooks, 3d


Diabetes is now a global pandemic, afflicting 346 million people worldwide, and Massachusetts is squarely in the forefront of this unforgiving disease:
• About 407,000 adults are diagnosed with diabetes and another estimated 114,000 adults lhave type 2 diabetes, but do not know it.

• From 2005 through 2008, diabetes was the ninth leading cause of death in the Commonwealth.

• In 2009, nearly 5 percent of Massachusetts adults reported they had been diagnosed with pre-diabetes, which is blood glucose levels that are higher than normal but not high enough to be diagnosed as diabetes.

• The cost of diabetes in Massachusetts is $4.3 billion annually.

• Since 1999, there has been a 61 percent increase in the number of people diagnosed with diabetes in Massachusetts, a trend that will continue unless we all work together to change things.

Type 1 diabetes is predominantly initiated by family genetic factors. Type 2 diabetes, is accelerated by obesity, lack of exercise, lack of awareness, and a healthcare system that historically has focused on paying for downstream complications rather than prevention and proactive encouragement of healthy diets, exercise, medication adherence, and behavioral health issues.

As the United States faces the prospect of the incidence of diabetes rising from one in 10 citizens today, to one in three in the next 40 years, a new national commitment to address this disease head-on is essential.

At the Joslin Diabetes Center, we are catalyzing this call to action with the goal of a world free of type 1 and type 2 diabetes and their complications. We are reaching out across the Commonwealth to engage organizations, community centers, schools of public health and many others, to bring resources and energy to providing culturally tailored educational programs, tools, team-based resources and impactful care plans to inform and motivate families and their health teams to work collectively to reverse or slow this relentless diabetes tidal wave.

On November 19 our community of doctors, patients, families, friends and advocates will gather for Joslin’s annual High Hopes Gala and World Diabetes Day Celebration, our most important night of the year. This event supports innovation and research aimed at creating a world free of diabetes and its complications.
We must build partnerships and cost-effective, risk-sharing collaborations with other healthcare providers, payers, and federal, state and city agencies to share and leverage our expertise in novel and measurable ways. This is what is needed to help patients, families, primary care doctors and other healthcare providers and payers to tackle this disease and its dreaded complications. We must make this a priority. Our lives -- and the lives of our loved ones -- depend on it.
John L. Brooks 3d is president and CEO of the Joslin Diabetes Center.

DIABETES AWARENESS MONTH BEGINS

Submitted by Lorenzo.Piemonte on Tue, 11/08/2011 - 09:26

In many parts of the world, the beginning of November marks the start of a month-long series of activities aimed at raising diabetes awareness and calling for urgent action to tackle the diabetes epidemic. Here's a reminder of why we all have to 'Act on Diabetes. Now.':

• New figures recently launched by the International Diabetes Federation indicate that the number of people living with diabetes has risen to 366 million.
• Diabetes is responsible for 4.6 million deaths a year - 1 every 7 seconds.
• Healthcare spending on diabetes has reached USD 465 billion.
• Diabetes is among the top 10 causes of disability, resulting in devastating complications such as blindness and lower limb amputations.
• All nations – rich and poor – are suffering the impact of the diabetes epidemic
• Diabetes is undermining global development.
• Diabetes hits the poorest hardest

World’s first stem cell bandage in human clinical trials

Press release issued 14 November 2011

The company behind a pioneering stem cell bandage, believed to be the world’s first adult and autologous (patient’s own) stem cell treatment designed to heal torn meniscal cartilage, can now take the technology to human clinical trials thanks to an investment from one of the UK’s most successful entrepreneurs.Mr Hugh Osmond, a partner of Sun Capital — who helped build Pizza Express into the UK’s largest sit-down restaurant chain and founded one of the country’s largest pub companies, the Punch Group — has completed a £0.65 million funding round for Azellon Cell Therapeutics Ltd, the University of Bristol spin-out company behind the therapy that has to date raised £2.25 million.
The company, which has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for the world's first clinical trial using its Cell Bandage product, is funded by existing investors IP Group plc, the developer of intellectual property based businesses — and Oxford Technology Management as well as new investors including lead funder, Mr Osmond.
Azellon’s Cell Bandage has been designed as an alternative to the current treatment of surgical removal of the meniscus (meniscectomy), a procedure that more than 1.7 million people around the world per year are estimated to undergo. This common orthopaedic procedure often results in the early onset of osteoarthritis, leading to further joint surgery including total knee replacement.
The Cell Bandage, which in vitro (tissue culture) has shown great promise for the healing of meniscal tears, is grown from the patient’s own stem cells and will be transplanted in the patient’s knee joint within two weeks of extracting the stem cells from bone marrow.
The MHRA approved Phase I/IIa trial will treat ten meniscal tear patients with a cell bandage product, seeded with the patient's own stem cells. The trial will be undertaken at Southmead Hospital in Bristol and is scheduled to begin in May 2012 with interim data available within 18 months.
Azellon is co-founded by Professor Anthony Hollander at the University of Bristol, who came to national prominence as part of the academic team that saved the life of Claudia Castillio, after developing the first tissue-engineered trachea (windpipe) using the patient’s own stem cells. This fully functioning airway was transplanted into the patient and saved her life.
Professor Anthony Hollander, Chief Scientific Officer of Azellon Cell Therapeutics Ltd and Head of the School of Cellular and Molecular Medicine at the University of Bristol, said: “With permission for a trial from MHRA and completion of this funding round, we are now ready to get going on our safety trial; it’s an important moment for Azellon and for stem cell research.”
Alan Aubrey, CEO of IP Group plc, said: “Azellon’s stem cell bandage is targeted at a very large and growing market with a clear medical need and we are pleased to support the company as it moves into its Phase I/IIa trial.”
Hugh Osmond, who has a medical degree from Oxford University, said: “As a keen sportsman who has had multiple knee operations myself, I believe that this procedure has the potential to be a major breakthrough in treating knee and eventually other joint injuries. For many of the 1.7 million people a year who have operations to repair torn knee cartilage, it could be the difference between an active old age or spending their pension years in a wheel chair. I am very excited.”

Students sign up to be life-savers

Published on Tuesday 8 November 2011 07:08

STUDENTS at Wigan and Leigh College responded superbly to a charity’s call to become lifesavers by signing up to the blood stem cell donor register.

London-based organisation Anthony Nolan held the recruitment drive at Leigh Sixth Form College, on Sale Way, to try and help increase the currently low numbers of men aged between 18 and 30 years old who are on the register, a campaign backed by Leigh MP Andy Burnham.

Around 30 students at the college signed up for the donation register, with other students who were not able to become donors as they were aged under 18 pre-registered for when they are old enough or given literature about stem cell donation.

More than 80 per cent of blood stem cell donations are from men, and men aged 18-30 are considered to be the ideal donors most likely to be asked to donate, yet just 12 percent of donors on Anthony Nolan’s register are from this age group.

To improve these figures, the charity has launched an ambitious recruitment drive to get 10,000 men in the target age group signed up, and Mr Burnham, who visited the recruitment drive at Leigh Sixth Form, is urging any fit and healthy young men in Wigan and Leigh to consider becoming a donor.

A college spokesman said: “Both the trust and the college were really pleased with the turnout, and with how many young people signed up. It was a very positive response. We weren’t quite sure how our student community would respond, as we all know how few donors there are but that doesn’t always translate into people taking the step to signing up, but there was lots of interest and they obviously wanted to make a difference.”

To join the register, all applicants have to do is fill out a short medical questionnaire and provide a sample of saliva.

A stem cell donation and transplant could save the life of someone with a blood cancer such as leukaemia, but currently Anthony Nolan is only able to find tissue type matches for half the patients who come to them. To become a donor, register online at www.anthonynolan.org