(HealthDay News) -- About one-third of children of deployed U.S. Army soldiers are at high risk for psychosocial problems, mainly due to high levels of stress experienced by the parent who is still at home, a new study shows.

The research included the spouses (mainly wives) of 101 deployed Army personnel. Participants completed a series of questionnaires and provided information about their children, aged 5 to 12.

The researchers concluded that 32 percent of the children were at high risk for psychosocial problems. This doesn't mean they had psychological problems, but that they were more vulnerable to developing such disorders. That rate is 2.5 times higher than among children in the general population.

The study also found that children of parents with high stress levels were about seven times more likely to be at high risk for psychosocial problems. Psychosocial problems were less likely among children whose parents received support from military organizations and among children of college-educated parents. Read more...

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When introducing a regenerative medicine cell based product to a commercial setting, there are a host of things to take into consideration to ensure a commercially viable and safe product for patient use.

In this QandA interview by Pharma IQ, William Fodor, Director of Translational Sciences, Cell Therapy Group, gives some teasers into a few of issues to keep in mind relative to commercial manufacturing scale?up of cell therapies.

Listen to the podcast here (registration required) or read the transcript below:

Pharma IQ:  Can you give some advice on the best way for a company to develop standards for
commercialization to improve safety?

William Fodor:  Well, with any biological product, you have to do all the appropriate testing and there’s really no standards necessarily to be developed by the company because the regulatory process is pretty well outlined by the FDA and the CBER Division and cell therapy products are regulated by the office of Cell Tissue and Gene Therapy Division.  So, it’s not that you need to develop standards for  commercialization to improve safety.  You need to follow the regulations involved by demonstrating to the FDA that your product is safe, and maintains the identity, in other words, your product doesn’t change during your regular manufacturing process.  Purity and then potency are all assays that need to be developed within the manufacturing process for your particular cellular product.


Pharma IQ:  And what are some approval processes and pitfalls to be aware of within the
scale?up process?

William Fodor:  So as you are scaling up, you absolutely need to maintain current good
manufacturing practices ? it’s known as cGMPs.  Typically, during a phase one, you can get
away with certain reagents that may not be fully GMPs.  Or in other words, if you use a growth
factor or a certain media that doesn’t have or isn’t manufactured under full GMPs,  as long as you test that particular reagent or media that you are using to ensure safety and sterility, you can typically get away with that in the phase one clinical trial process.  But when you move to a phase two, you need to make sure that all your reagents and medias and any compounds that come in contact with your product are all manufactured under good cGMP.

Pharma IQ:  What are some technology transfer and patent protection concerns to be
cognizant of?

William Fodor:  Well, with any cellular?based product, if there’s a technology that is out there
that a company wishes to pursue, to improve yield, or the manufacturing process, you need to
demonstrate that that technology fits within your manufacturing process.  So typically, what is
done is you’ll do validation runs to ensure that that new technology satisfies the regulatory
process for your manufactured product. With respect to patent protection, again, that company needs to maintain their IP portfolio and needs to make sure that they’re not infringing other intellectual property and that’s just standard for the industry.

Pharma IQ:  And do you have any tips for ensuring quality and consistency no matter how little
or how much one is producing?

William Fodor:  Yes, when you manufacture a cell?based product, it’s not that much different than any other biologic product.  And so, whenever you do manufacture, whatever scale it is, you have to ensure safety, and that’s sterility, tests for microplasma, or other adventitious agents; things like bioburden and endotoxins, so all those tests need to be performed. You need to have an identity test to make sure that your cell product ,whatever scale your manufacturing is, that at the end of that manufacturing run, the product hasn’t changed.   Again, no matter what scale you’re at, you need to make sure the identity of the product is
consistent from batch to batch.

For identity, you can do a number of things, and again, for a cell?based product, if you want to look at cell surface antigens to ensure that the cell surface proteins on your cellular product don’t change over time or through your manufacturing process.  And typically, what you like to do is keep it relatively simple.  You don’t want to test for a hundred things because you’re just asking for the potential for something within those hundred things to change.  So typically, what you do is maybe three to four cell surface antigens to ensure your product identity is consistent and you can also do PCR to determine that an intracellular protein of interest doesn’t change during your manufacturing process.

You also need to ensure for purity, so you want to quantitate your active cell or your tissue type.  And then potency; you need to demonstrate the product has a consistent potency and the biological activity of that final product doesn’t change during the manufacturing process.   And then typically, what you do is you archive.  You archive samples from during your manufacturing process. You cryopreserve those so you can always go back to ensure that that a particular batch was consistent with other batches that were manufactured.
...

Join Dr. Fodor and other industry leaders in Philadelphia, December 12th and 13th 2011 for the IQPC Commercialization of Regenerative Medicine Summit.  For more information or to register, visit
http://www.regenerativemedicinesummit.com.

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4–5 According to the World Health Organization, one in four of us will develop at least one mental illness or behavioral disorder in our lifetime. Depression alone affects an estimated 121 million people worldwide. At the two-day EMBO/EMBL Science and Society Conference , biologists, psychologists and neuroscientists will explore the ethical and social implications of major mental illnesses as well as their causes and treatment. Attendees will debate the definitions of mental disorders, financial interests in the refinement of both diagnoses and drugs, and controversial new therapies, among other topics. [More]

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Exact details of the alternative natural and traditional therapies tried by Steve Jobs before he underwent surgery in 2004 and eventually died of pancreatic cancer earlier this month have not been disclosed. (A representative from Apple declined to comment on any aspect of the Apple co-founder's illness.) He reportedly restricted his diet to just fruits or just fruits and vegetables, tried out something called hydrotherapy and consulted psychics. In any case, a mounting body of scientific and anecdotal reports provides compelling evidence about the potential impact, both positive and negative, of so-called complementary practices on the health and longevity of cancer patients following their diagnosis. And, although Jobs's unconventional early-treatment choices may not have done much to stave off the spread of deadly cancer cells in his case, they provide an opportunity to discuss what makes cancer grow and how to stop it.

Jobs had a rare form of pancreatic cancer known as pancreatic neuroendocrine tumor (pNET). Accounting for about 1 percent of all pancreatic cancers, pNET is a cancer of the endocrine cells, known clinically as the islets of Langerhans, which exist in small clusters throughout the pancreas. These cells produce hormones such as insulin, which lowers blood sugar, and glucagon, which increases it.

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Steve Jobs was a rare case, right down to his death. Announced Wednesday, Jobs's death from "complications of pancreatic cancer" only hints at the vast complexity of the disease to which he succumbed at the age of 56. [More]

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No organ in the human body is as resistant to study as the brain. Whereas researchers can examine living cells from the liver, lung and heart, taking a biopsy of the brain is, for many reasons, more problematic.

The inability to watch living human brain cells in action has hampered scientists in their efforts to understand psychiatric disorders. But researchers have identified a promising new approach that may revolutionize the study and treatment of conditions such as schizophrenia, autism and bipolar dis­order. A team led by researchers at the Salk Institute for Biological Studies in La Jolla, Calif., took skin cells from a patient with schizophrenia, turned them into adult stem cells and then grew those stem cells into neurons. The resulting tangle of brain cells gave neuroscientists their first real-time glimpse of human schizophrenia at the cellular level. Another team, from Stanford University, converted human skin cells directly into neurons without first stopping at the stem cell stage, potentially making the process more efficient. The groups published their results recently in Nature ( Scientific American is part of Nature Publishing Group).

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"Even if your mother says it is true, check it out," an old saying goes. So we did.

The case in point was the new financial arrangement for the $3 billion California stem cell agency.

CIRM Chairman Jonathan Thomas laid out the plan last month for the California Stem Cell Report in the wake of a state bond issue that provided only $51 million for the agency, which fell far short of its needs over the next year or so. He said, however, a new arrangement was in place that amounted to a win-win for the state and the stem cell agency. The plan minimizes the amount of state bond borrowing immediately needed and instead provides, if necessary, short-term commercial paper, also backed by the state, but at less interest cost.

Thomas said both the state treasurer and the Brown Administration, through its state Department of Finance, were on board.

But -- keeping the admonition about mothers in mind -- we routinely asked the Finance Department and the state treasurer's office about the arrangement. What happened then provides some insight into how difficult it is sometimes to verify even what appear to be simple facts. It also tells a story about the responsiveness of state agencies and their dedication to openness and transparency.

Let's start with CIRM and Thomas. After we raised questions by email following the state bond sale Oct. 19, he offered a telephone interview about the situation and persisted despite dropped cellular signals and several callbacks from our post here in the bay off Panama City.

After we filed our item on the interview, we queried on Oct. 24 the other two agencies involved. The state treasurer's office responded quickly. The state Department of Finance, on the other hand, has remained silent on the subject to this day, despite three emailed queries.

Unfortunately, the state treasurer office's initial response was off the mark. "We haven’t seen any agreement.  We were not aware of the reported agreement until we read about it in your blog.  So, we have no comment about the reported agreement," the treasurer's office said initially.

That raised eyebrows a bit. So we renewed our queries to the Finance Department, even suggesting that a failure to respond could be construed as an indication that the Brown Administration is not fully behind CIRM.

Ten days after our initial query to the two agencies, we sent an email to Thomas briefly describing what we had planned to write and asking him if he would like to comment. He did not respond. But the next day, Steve Cooney, chief deputy state treasurer, said in an email that the earlier comment from the treasurer's office was incorrect. Cooney said,

"Our office DOES (Cooney's capitalization) and DID know that CIRM and the Department of Finance reached an understanding about future funding.

"The Treasurer’s Office has been aware since before last month’s sale of GO (general obligation) bonds that the Department of Finance and CIRM are in general agreement that the state will take necessary action to ensure that CIRM has adequate funds to meet its operational, grant funding and reserve needs, including the use of the state’s commercial paper line in the event the state cannot timely access the bond market.  It is neither necessary nor usual for our office to be informed of the specifics, if any, of any future commitment made by the Administration to any other state agency, including CIRM, and this case is no exception."

Cooney additionally re-affirmed the commercial paper arrangements for CIRM as laid out in the initial response from the treasurer's office.

The response said,

"The issuance of commercial paper has always been a part of our bond financing program.  The size of the CP line is about $1.5 billion, and it is available for use by all infrastructure programs, including stem cell research.  When we issue commercial paper to finance infrastructure projects, including CIRM, the paper is repaid with bond-sale proceeds.  So, if CIRM received funds from the issuance of commercial paper, the 'loan' would be retired not by CIRM, but by the proceeds of a subsequent bond sale."

Cooney also said,

"If you still need further clarification on the issue of future CIRM funding beyond the proceeds of the recent bond sale, the best place to get that information continues to be the Department of Finance."

Silence, however, has only been heard from the state Department of Finance.

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The president of the California stem cell agency, Alan Trounson, popped up in a recent article in Scientific American dealing with a method for creating pluripotent stem cells from unfertilized human eggs.

The piece by Julia Galef said that "many investigators remain frustrated" that the method "remains offlimits" for federal funding, a barrier that does not apply to financing from the $3 billion California stem cell agency.

Galef wrote that one California firm, International Stem Cell Corp., of Carlsbad, is using the method to develop products. She said the firm's work involves "a process called parthenogenesis, in which researchers use chemicals to induce the egg to begin developing as if it had been fertilized. The egg—called a parthenote—behaves just like an embryo in the early stages of division. Because it contains no genetic material from a father, however, it cannot develop into a viable fetus."

Trounson was quoted as saying, nonetheless, that "proving that unfertilized eggs will produce stable tissues in humans remains an obstacle." He said other labs need to replicate the work.

International Stem Cell has applied unsuccessfully several times for research funding from the California stem cell agency.

The Scientific American article said,

"International Stem Cell scientists have converted them into liver cells and plan to convert them into neurons for treating Parkinson’s disease, pancreatic cells for diabetes, and other tissues. Meanwhile teams at the Massachusetts-based Bedford Stem Cell Research Foundation are working to improve the efficiency of methods of deriving stem cells from parthenotes."

As researcher interest in parthenotes gains attention, the NIH is being urged to change its negative position. Late last year, Teresa Woodruff, founder and director of the Institute for Women's Health Research at Northwestern University Feinberg School of Medicine, and others called for a lifting of the NIH ban on funding for parthenotes.

California is not constrained by NIH limitations. One of the key reasons, if not the only reason, that voters approved in 2004 the ballot initiative that created the $3 billion stem cell agency was to fund research that the federal government did not. At the time, the focus was on the Bush ban on financing hESC research.

Ken Aldrich, co-chairman of International Stem Cell, circulated the Scientific American article, touting its significance.

We found this posting on the Stem Cell Pioneers web site in which Aldrich said,

“We at International Stem Cell Corporation (ISCO.OB) are finding it increasingly gratifying that mainstream and highly respected publications like Scientific American are now beginning to take notice of the fact that our parthenogenetic stem cells may well turn out to be a viable alternative to the embryonic stem cells that have dominated research and headlines for the last 10 years.

"Like embryonic stem cells, our parthenogenetic stem cells can be converted into almost any kind of cell that might ever be needed for therapy, but can also provide a solution to the two biggest issues that have surrounded embryonic stem cell research: 1) the ethics of destroying a fertilized embryo, which our process never does, and 2) the problem of immune rejection by the patient. We hope you enjoy the attached article." 

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Description and use for different types of stem cells: Multipotent

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The Power of Stem Cells - Video

Promoting an excellent show! http://www.coasttocoastam.com Author and researcher Christian Wilde reported on alternative approaches to treating heart disease. In the third hour, he was joined by holistic expert Gabriel Cousens, MD, and raw food authority David Wolfe. Wilde noted that turmeric has been shown to have strong anti-inflammatory properties in the body, and the arteries in particular.

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Stem Cell Research

Human pluripotent stem cell derived cardiomyocytes (cardiac tissue), produced and grown with proprietary processes, self-organizing to form large 3-dimensional tissues visible to the unaided eye. The interaction and role of the cardiomyocytes, and other heart-related cells that differentiate in these cultures in the formation of stable functional adult cardiac tissues, are being studied.

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VistaGen's Stem Cell Derived Cardiomyocytes - Video

Insight into the world of stem cell research. This 15-minute film uses innovative hand-drawn animation, beautiful cell photography and documentary interviews to capture the fascination and complexity of this cutting-edge area of science.

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A Stem Cell Story - Video

DOWNLOAD HERE: newsdirect.nma.com.tw US scientists have succeeded in producing embryonic stem cells using a new cloning technique. They injected genetic material from a diabetic patient's skin cell into a donor egg, and stimulated it to develop enough so stem cells could be extracted. The result is stem cells with 69 chromosomes - one set of 23 more than a normal human's 46 - meaning they cannot be used for cell replacement therapy yet.

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US scientists unveil new cloning method for embryonic stem cells - Video

VP Heather Livingston's training on DermaStem™ from the 2011 Stemtech Convention.- Part 1 ... Our breakthrough serum revitalizes the skin at the cellular level, to restore and maintain the skin's youthful vibrance. DermaStem™'s all-natural ingredients provide the ideal environment for the regenerative properties of the adult stem cells, supporting the natural process of skin renewal.

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Turning Science Into Action with Heather Livingston - Part 1 http://www.miraclecell.info - Video

Pre-Medical Society's Outstanding Service Award in Medicine Award -- This year's recipient is John F. Tisdale, Class of 1986 and the son of Belton and Sara-Gantt Tisdale, Class of 1956. After completing his degree in chemistry at the College, John received his medical degree from MUSC in 1990 and did his internship and residency at Vanderbilt in internal medicine.

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Alumni Profile: Dr. John Tisdale, NIH Researcher, Stem Cell Transplants and Sickle Cell - Video

A study appearing in the September 17, 2010 Journal of Biological Chemistry shows that wisdom teeth contain a valuable reservoir of tissue for the creation of stem cells; thus, everyone might be carrying around his or her own personal stem-cell repository should he or she ever need some. The molar-derived cells also could differentiate into many other cell types including beating cardiomyocytes (as in this YouTube video), as expected.

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Stem Cells: A smart use for wisdom teeth - Video

Transplanted adult stem cells have been found to reverse paralysis associated with spinal cord injuries in lab rats, a new study finds. youtu.be The study, headed up by Miodrag Stojkovic, deputy director and head of the Cellular Reprogramming Laboratory at Centro de Investigacion Principe Felipe in Spain, involved transplanting so-called progenitor stem cells from the lining of rats' spinal cords into rodents with serious spinal cord injuries. youtu.be The rats recovered significant motor activity one week after injury, Stojkovic and his co-authors wrote in the Jan

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Biological Physics : Stem Cells - Paralyzed Spinal Cord Injury Patient Walks Again - Video