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Human Embryonic Stem Cells for Predictive Toxicology – Video

By LizaAVILA

(Part 3 of 4) Michael McMaster, PhD, spoke at a seminar about stem cell research and environmental health held on September 30, 2009 at the California Institute for Regenerative Medicine. McMaster summarized the challenges of predictive toxicology and described how he has applied human embryonic stem cells as a model system for studying the toxicological effects of nicotine

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Stem Cell Skin Care Jeunesse- Dr Newman FAQ – Video

By NEVAGiles23

http://www.smootherskin.info Dr Newman is the innovator who formulated our anti-aging skin care line. Watch as he answers some inportant questions regarding the stem cell skin care.

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Getting Stem Cell Therapies Approved: Ann Tsukamoto – CIRM Science Writer’s Seminar – Video

By Dr. Matthew Watson

(Part 7 of 9) Ann Tsukamoto, Ph.D., spoke at the Scientific Writer's Seminar, a workshop presented on September 17, 2008 at CIRM headquarters in San Francisco. Tsukamoto is the Chief Operating Officer at Stem Cells, Inc., a Palo Alto based company that has begun a stem cell based human clinical trial for the treatment of Batten disease.

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Austin Forum – Nov 1st (Highlights) – Video

By daniellenierenberg

Stem Cell Therapy in the Treatment of Patients with Ischemic Heart Failure Emerson Perin, MD, PhD., Director, Clinical Research for Cardiovascular Medicine and the Medical Director of the Stem Cell Center, Texas Heart Institute, St. Luke's Episcopal Hospital Scientific advancements in the stem cell field can lead to new treatments and therapies for diseases and medical disorders for which we have few or no effective medications or treatment options.

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AVS Stem Cell Therapy – Video

By daniellenierenberg

Watch as the veterinary surgeons at Affiliated Veterinary Specialists perform a breakthrough stem cell therapy to treat arthritis. The patient is Maggie Mae, a ten-year-old Australian Shepherd.

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AVS Stem Cell Therapy - Video

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StemCellTV – From National Geographic – The Skin Gun – Healing Burns with Stem Cells – Video

By Dr. Matthew Watson

Courtesy of National Geographic TV, StemCellTV reports on the skin gun. McGowan Institute of Regenerative Medicine takes a burn victims stem cells from his skin and regenerates skin to heal him in 4 days.

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Beating Cardiomyocytes in Cell Culture – Video

By Dr. Matthew Watson

The cells shown are beating cardiomyocytes derived from human induced pluripotent stem cells.

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SCIPIO: Cardiac stem cells and postinfarction heart failure – Video

By NEVAGiles23

Mark Sussman, PhD, interviews Piero Anversa, MD, FAHA and Roberto Bolli, MD on the results of the SCIPIO trial at the American Heart Association's Scientific Sessions 2011.

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Adult Stem Cell Success Stories – Amy Daniels – Video

By LizaAVILA

StemCellResearchFacts.com - Amy Daniels was terrified when she learned that she had Scleroderma- a disease that causes the tissue in the skin, blood vessels, and muscles to harden.

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Bone Marrow Stem Cell Injections – Video

By NEVAGiles23

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Beating iCell® Cardiomyocytes – Video

By Dr. Matthew Watson

A synchronously beating monolayer of cardiomyocytes (heart cells) derived from induced pluripotent stem cells.

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Where Do The Stem Cells Come From? Hollywood | Los Angeles – Video

By NEVAGiles23

metromd.net Where Do The Stem Cells Come From? A discussion of the different sources of stem cells for therapy and autologous treatment by Alex Martin, MD

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Macular degeneration – Stem Cell therapy (English subtitles) – Video

By NEVAGiles23

This video, is a testimonial of a patient from Argentina that went to Progencell, for a Stem cell treatment for his Macular degeneration. Talks about his experience, his trip, the procedure, the outcome and some suggestions. Language Spanish with english subtitles, 6 min duration aprox.

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Perspectives of a Stem Cell Donor Family – Video

By daniellenierenberg

"Your twin daughters have an extremely rare, fatal disease called Niemann Pick Type C and there's nothing you can do for them." Those were the devastating words that Chris Hempel and her husband first heard in 2007. Rather than just give in to this fate, the Hempels are proactively engaging researchers to try to save Addi and Cassi's lives. This journey includes donating skin samples to cell banks so that researchers can create induced pluripotent stem (iPS) cells, a promising technology which may help undercover treatments for their daughters

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Kids of Deployed Soldiers Vulnerable to Stress

By Dr. Matthew Watson

(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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Commercializing Cell-based Regenerative Medicines

By Dr. Matthew Watson

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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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Calendar: MIND Events in November and December

By Dr. Matthew Watson

NOVEMBER

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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Did Alternative Medicine Extend or Abbreviate Steve Jobs’s Life?

By Dr. Matthew Watson

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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The Puzzle of Pancreatic Cancer: How Steve Jobs Did Not Beat the Odds—but Nobel Winner Ralph Steinman Did

By Dr. Matthew Watson

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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Studying Mental Illness in a Dish

By Dr. Matthew Watson

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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