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Fairfield vet hospital performs stem cell treatments

By adminMarch 15, 2014Stem Cell Treatment

A Fairfield veterinary hospital is using stem cell treatment to help ailing dogs suffering from joint pain and even hip dysplasia.

Officials said Woodridge Veterinary Hospital is one of the few places that have performed these procedures.

On Friday Bosco, an 11-year-old Labrador, was in for surgery on his arthritic knees.

Doctors took fat out of Bosco, extracted the stem cells and then injected the stem cells back into Boscos knees.

Doctors said Bosco will have a little bit of swelling after the procedure but in four or five weeks he should be feeling much better.

Dr. Roberto Legorreta explained how stem cells are naturally used in the body.

"Every time that a trauma happens or anything that happens in our body, the stems cells are what get activated to regenerate that tissue. That's how we heal," Legorreta said.

Legorreta touched on the importance of this procedure and the excitement that goes along with it.

"I think this is the future of medicine, truly, in many many ways, and we're glad to be at the forefront of that, Legorreta said.

FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering, Etc.

By adminMarch 14, 2014Stem Cell Medicine

Course Description: Regenerative medicine focuses on harnessing the power of ones own stem cells and regenerative capabilities to restore function to damaged cells, tissues and organs. In April 2006, the U.S. Food and Drug Administrations (FDA) implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products (HCT/Ps) in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products. Currently, there is an ongoing debate in the industry on how such therapies should be regulated by FDA or under the practice of medicine, under federal law or state law, and as drugs or simply biologics.

This 2-day interactive seminar on FDA regulations of regenerative medicine will cover:

-How FDA is currently regulating regenerative therapies and products intended for both human and veterinary use. -The distinction being made between human regenerative products and their regulation as drugs, biologics, devices, and combination products. -The New Drug Application (NDA) and the Biologic License Application (BLA) review and approval processes including a discussion of available options, application components, relevant meetings, timing, costs and approval requirements. -The option for obtaining designation and approval as Orphan Drug Product. -Designing and conducting appropriate clinical trials to support the approval of regenerative therapies. -FDAs regulation of some regenerative medicine products and accessories as Medical Devices. -The Current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs) being applied by FDA to human regenerative products. -The labeling and marketing of regenerative products and therapies. -The potential for enforcement action and recommendations for mitigating that risk. -The current regulation of veterinary cellular treatments including autologous, allogeneic and xenogeneic cellular products in the United States.

Learning Objectives: Participants who attend this course on FDA regulation of regenerative medicines will leave with a comprehensive understanding of:

-How FDA regulates regenerative treatments and therapies? -The HCT/P Criteria and Minimal Manipulation Standard. -The Drug and Biological Approval Process. -Regenerative Products as Medical Devices. -How to Design Appropriate Clinical Trials? -Applicable cGMPs and cGLPs. -Marketing Exclusivity and Patent Restoration. -Product Labeling, Marketing and Advertising. -FDA and other Federal Agency Enforcement Action. -The Regulation of Veterinary Regenerative Medicine. -The New Animal Drug Application (NADA) Process. -Veterinary User Fees and Waivers.

Who will benefit: This course is designed for professionals in stem cell, biotech, pharmaceutical and animal drug companies, veterinary hospitals and clinics. The following personnel will find this session valuable:

-Senior quality managers -Quality professionals -Regulatory professionals -Compliance professionals -Production supervisors -Manufacturing engineers -Production engineers -Design engineers -Labelers and Private Labelers -Contract Manufacturers -Importers and Custom Agents -U.S. Agents of Foreign Corporations -Process owners -Quality engineers -Quality auditors -Document control specialists -Record retention specialists -Medical affairs -Legal Professionals -Financial Advisors and Institutional Investors -Consultants, Inspectors and cGMP Experts

Academic social network ResearchGate aids debunking of stem cell study

By adminMarch 14, 2014Stem Cell Medicine

5 hours ago Mar. 14, 2014 - 3:36 AM PDT

ResearchGate, the 4-million-strong academic social network, has just scored a major victory in its quest to turn the research process upside-down its platform proved instrumental in the debunking of a major stem cell study, which on Friday resulted in a very apologetic roll-back from the Japanese institute that put out the original study.

The original study came out in Nature, the peer-reviewed scientific journal, earlier this year. It purported to show that it was possible to turn normal blood cells into master stem cells by dipping them in a mild acid solution. Stem cells hold great promise for the future of medicine, but theres a lot of controversy around current harvesting techniques, particularly when embryos are involved, and this would have provided a terrific workaround.

Unfortunately, while the Riken institutes research promised great things, other researchers found themselves unable to reproduce the results. One, a Hong Kong professor of regenerative medicine named Kenneth Lee, used his ResearchGate profile to publish his and his students findings, demonstrating a failure to get this technique to work.

There had been a good deal of grumbling about the Nature paper, but Lees ResearchGate publication provided the final straw and Riken admitted the original Nature papers contained errors. One of the key researchers there has now had her research suspended, and investigations are underway at both Riken and Nature.

This is what I was dreaming of, ResearchGate CEO Ijad Madisch told me. Indeed, Madisch has long advocated the advantages of post-review over pre-peer review.

Rather than the traditional system, where a paper is submitted to a journal like Nature and pored over for months by a couple of reviewers, he wants to see a system where all research is published openly and immediately not only does this bring more eyes to the research, but it also means that unsuccessful results get as good an airing as the successful ones. Thats something that should save other researchers an awful lot of time.

Bill Gates likes this approach, which is why he has poured millions into ResearchGate. And, although the discussion around it occurred in more places than just ResearchGate, the stem cell episode provides a good deal of validation.

According to Madisch, researchers who have found it difficult to reproduce the results of published papers have generally had trouble getting as much attention as those behind the published paper the press, certainly, are keener to trumpet a study that has been peer-reviewed than something that may come from a hater and that journalists feel unable to evaluate themselves.

The excitement around Lees activities on ResearchGate led the startup to speed up the completion of a new feature called Open Review, which is designed to make it easier for users to give open feedback to papers published on the network. The feature combines a structured feedback mechanism with commenting facilities.

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Academic social network ResearchGate aids debunking of stem cell study

New cell line should accelerate embryonic stem cell research

By adminMarch 14, 2014Stem Cell Medicine

1 hour ago by Michael Mccarthy Dr. Carol Ware at work in her laboratory at the Institute for Stem Cell and Regenerative Medicine. Credit: Bryan Donohue

Researchers at the University of Washington have successfully created a line of human embryonic stem cells that have the ability to develop into a far broader range of tissues than most existing cell lines.

"These cells will allow us to gain a much greater understanding of normal embryonic development and have the real potential for use in developing ways to grow new tissues and organs for transplantation," said Carol Ware, a professor in the UW Department of Comparative Medicine and lead author of a paper describing the new cell line appearing in the March 10 issue of the journal Proceedings of the National Academy of Sciences.

The cells, called nave embryonic stem cells, normally appear at the earliest stages of embryonic development and so retain the ability to differentiate in all the different types of cells of the human bodya capacity called pluripotency.

Researchers had been able to develop naive cells using mouse embryonic stem cells but to create naive human embryonic stem cells has required inserting a set of genes that force the cells to behave like naive cells.

While these "transgenic" cells are valuable research tools, the presence of the artificially introduced genes meant the cells will not develop as normal embryonic cells would nor could they be safely used to create tissues and organs for transplantation.

In an article, Ware and her colleagues from the UW Institute for Stem Cell and Regenerative Medicine describe how they successfully created a line of naive human embryonic stem cells without introducing an artificial set of genes.

They first took embryonic stem cells that are slightly more developed, called primed stem cells, and grew them in a medium that contained factors that switched them backor "reverse toggled" themto the naive state.

They then used the reverse toggled cells to develop a culture medium that would keep them in the naive state and create a stable cell line for study and research.

Then having worked out how to maintain the cells in the naive state, Ware and her colleagues harvested naive cells directly from donated human embryos and cultured them in the maintenance medium to see if they could create a stable cell line that had not undergone reverse toggling. After many tries, they succeeded.

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New cell line should accelerate embryonic stem cell research

Riken Apologizes for Errors in Two Stem Cell Studies

By adminMarch 14, 2014Stem Cell Medical Center

Japans Riken center apologized for errors in a pair of studies that had outlined a simpler, quicker way of making stem cells and said the institute is considering urging the scientists to retract it.

Riken will impose a penalty if misconduct is proven, President Ryoji Noyori said in news conference today. Haruko Obokata, who led the research, and two other Riken researchers in a separate statement on the centers website said they are in talks with co-writers to discuss a retraction.

Government-funded Riken on March 11 said is investigating the two studies that were published in journal Nature in January and said ordinary cells taken from newborn mice could be transformed into stem cells without adding genes. The institute today said it was investigating six images and methods in the research after claims that they looked unnatural or were plagiarized from other studies.

We are communicating with other authors and considering the possibility of retracting the studies, Obokata and the two other researchers, Yoshiki Sasai and Hitoshi Niwa, said in a joint statement on Rikens website today.

Two areas were handled inappropriately, though researchers didnt have intent to falsify data, the institute said on its website. The center is still investigating the rest, it said.

Images used in the studies to show the establishment of the method resemble photos from Obokatas previous studies, Kyodo News reported this week. Another scientist, Teruhiko Wakayama at the University of Yamanashi in Japan who worked on the research said he was no longer sure of the premise of the data he used to establish the experiments and that the studies should be withdrawn for review, public broadcaster NHK reported on March 10.

The probe is a setback for Japan as it tries to push into stem-cell science following Shinya Yamanakas 2012 Nobel Prize. Japan aims to cement its leadership in the field of research, and has pushed through bills that fast-track regulatory approval for cell-based products.

Researchers led by Obokata at the Riken Center for Developmental Biology shocked the cells with a dose of sublethal stress such as mechanical force to trigger a transformation. Obokata worked with institutions including Charles Vacantis laboratory at Brigham and Womens Hospital, Harvard Medical School.

In an embryos early stages, stem cells are pluripotent, meaning they can become any type of tissue in the body. As the embryo develops, the cells begin to specialize, or differentiate, into units for the bodys different structures.

There are several ways to regenerate pluripotent stem cells, including one that uses embryos and one that reprograms matured cells by inserting genes. Last year, Japans Health Ministry cleared the way for the worlds first clinical trial with stem cells made using a separate technique established by Yamanaka, the Nobel Prize winner from Kyoto University.

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Riken Apologizes for Errors in Two Stem Cell Studies

Harrison County Man Seeking Stem Cell Treatment to Restore Vision

By adminMarch 14, 2014Stem Cell Treatment

For some people battling illness, stem cell research has proven to make all the difference in their treatment, and a Harrison County man is hoping to join the ranks of those success stories.

Bobby Swiger works at the YMCA in Clarksburg as a personal trainer and goes to school full time for massage therapy. But for Swiger, life is a little more challenging than one would envision.

"I don't want to be the outsider anymore," said Swiger.

As a child, Swiger was diagnosed with Retinitis Pigmentosa, or RP, a degenerative disease he inherited from his mother.

"I was always forced to carry large books to school, large print. So I was always kind of noticed more than I wanted to be. At one point, I actually had a large screen monitor which I had to use to read my books with," said Swiger.

"I learned little tricks to get around it, and I've learned how to trick people to thinking I was normal," said Swiger.

Like others suffering from RP, Swiger is legally blind. During the day, he can see blurred images, but in the dark, everything goes black - literally.

"I'm not really a bar person, but I would like the opportunity to go to a bar and get a drink if I want, but I can't, because if I go into a bar, I'm gonna run into people, probably cause a bar fight 'cause I can't see the guy in front of me," said Swiger.

When it comes to his classes, Swiger says he relies heavily on the help of his teachers at the Clarksburg Beauty Academy, and at home, his girlfriend.But he's ready to be more independent with the help of stem cell treatment.

"They'll take the stem cells out of my hip and inject it into my eye itself. One individual who has had this treatment before me, at the same level I am currently, he was increased to 20/80, which is enormous," said Swiger.

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Harrison County Man Seeking Stem Cell Treatment to Restore Vision

Man hoping for third stem cell match after first 2 donors back out

By adminMarch 13, 2014Stem Cell Doctors

Watch the video above:Leukemia patient Chris Taylor loses 2nd bone marrow transplant donor. Angie Seth reports.

TORONTO A 36-year-old leukemia patient is searching for a bone marrow donor for the third time, after his first two donors backed out for medical or unknown reasons.

Chris Taylor was diagnosed with leukemia in 2012. He originally went to Mount Sinai hospital with chest pains and spent several days in the ICU though doctors couldnt figure out what was wrong with him, he said.

But several weeks later, Princess Margaret Hospital found his cancer at the chromosomal level. HE immediately started chemotherapy and it went into remission.

It came back after ten months, he said. I was starting to feel better and the side effects were starting to wear off and then the cancer came back.

They found a match around Christmas of 2013, he said. They started preliminary testing and even got a proposed date but two days before, the donor pulled out.

Unfortunately that donor was medically unfit to donate, Taylor said.

So they went back to searching. They found another donor.

We began again the process of getting ready to go in for the transplant, he said. Unfortunately for unknown reasons that donor had to opt-out of the procedure.

I was disappointed but I dont hold any ill-will or anything like that.

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Man hoping for third stem cell match after first 2 donors back out

Leukemia patient pins hopes on OneMatch stem cell donor registry

By adminMarch 13, 2014Stem Cell Doctors

Each day is a gift for Chris Taylor and every phone call could be the one that saves his life.

Thats why the 36-year-old man with acute myeloid leukemia keeps his cellphone within reach, waiting to hear that a stem cell donor has been found and hell get the bone marrow transplant he needs.

Taylor, who was diagnosed in July 2012, has already had two false alarms but is confident a match will become available before its too late.

Getting the call is a miracle in itself. It comes after an online search of unrelated people by the Canadian Blood Services OneMatch Stem Cell and Marrow Network. The registry has access to 22 million potential volunteer donors in 71 countries, strangers prepared to help those like Taylor.

Despite popular belief, family members are matches only 25 per cent of the time, said Mary-Lynn Pride, a patient transplant liaison specialist at OneMatch.

More than 800 Canadians currently await transplants. OneMatch has more than 333,000 registered Canadian donors.

Taylor signed up after a second round of chemotherapy last summer, when doctors at Princess Margaret Hospital advised he needed a bone marrow transplant.

Taylor received the first call last November. The timing was perfect because his cancer was in remission, the only time a transplant can be done.

Two days before he was to be admitted to hospital, Taylor got bad news. The procedure was cancelled because the donor had unspecified medical complications, he said. OneMatch does not say why donors decide to abandon the procedure.

The second call came last month, but the donor withdrew for reasons unknown to Taylor.

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Leukemia patient pins hopes on OneMatch stem cell donor registry

Stem Cells | ICMS — Advancing Stem Cell Treatments, Stem …

By adminMarch 13, 2014Stem Cell Medicine

T he International Cellular Medicine Society (ICMS) is an international non-profit dedicated to patient safety through strict evaluation of protocols and rigorous oversight of clinics and facilities engaged in the translation of point-of-care cell-based treatments.As a Professional Medical Association, the ICMS represents Physiciansand Researchersfrom over 35 countries who share a mission to provide Scientifically Credible and Medically Appropriate Treatments to Informed Patients.Join the ICMS.

The ICMS Works Tirelessly for the Clincial Translation of Field of Cell-Based Point-of-Care Treatments through:

Comprehensive Medical Standards and Best Practice Guidelines for Cell Based Medicine,

Strict Evaluation and Rigerous Oversight of Stem Cell Clinics and Facilities through aGlobal Accreditation Process,

Physician Education through daily updates on the latest Research on Stem Cells, the monthly Currents In Stem Cell Medicine and the annual International Congress for Regenerative and Stem Cell Medicine.

Join the ICMSto receive the latest news and research from cell-based medicne, including the bi-monthly publication, Currents in Stem Cell Medicine.

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Stem Cells | ICMS -- Advancing Stem Cell Treatments, Stem ...

Scientist admits mistakes in stem cell 'discovery'

By adminMarch 13, 2014Stem Cell Medicine

The Japanese scientists who made an apparently groundbreaking discovery in the field of stem cell research earlier this year has called for his research to be withdrawn amid speculations about the validity of the findings.

In January the researcher claimed to have discovered that stem cells could be made quickly and cheaply by simply dipping cells in acid to convert them into the biological building blocks. But the images used in the report were brought into question and other teams of researchers have failed to emulate the results.

The study's author Professor Teruhiko Wakayama said, "It is no longer clear what is right."

Stem cells are set to play a vital role in the future of regenerative medicine as they can transform into any other type of tissue. Teams of scientists are exploring their application in restoring sight to the blind and mending damage caused by heart attacks.

The original study was published in the journal Nature and hit headlines after being branded a

"major scientific discovery" as it suggested stem cells no longer had to be taken from embryos or made with complex and costly genetic manipulation.

While the pioneering findings, which suggested simply shocking cells with acid could cause them to revert to stem cells, has not been discredited it has been called into question.

Wakayama reportedly told Japanese TV, "When conducting the experiment, I believed it was absolutely right. But now that many mistakes have emerged, I think it is best to withdraw the research paper at once and, using correct data and correct pictures, to prove once again the paper is right.

"If it turns out to be wrong, we would need to make it clear why a thing like this happened."

WENN.com

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Scientist admits mistakes in stem cell 'discovery'