Stem Cell Clinic

PROPOSED STEM CELL TREATMENT ON TRACK

By Stem Cell Treatment

By Bradley J. Fikes U-T 12:01 a.m.Feb. 19, 2014

A proposed Parkinsons disease treatment from stem cells is on track for an application to be filed with federal regulators around the start of 2015, International Stem Cell Corp. said Tuesday.

The Carlsbad company said the U.S. Food and Drug Administration had met with researchers for guidance on what steps need to be taken before filing an application.

The meeting went about as expected, said Simon Craw, executive vice president. Ongoing animal studies must be completed, along with safety testing. FDA officials discussed details, such as the number of animals to be tested and how the safety studies are to be conducted, Craw said.

International Stem Cells treatment consists of progenitor cells that mature into neural cells, including those making the neurotransmitter dopamine. These neurons are destroyed in the disease, causing progressive paralysis.

The progenitor cells are to be implanted into the brains of Parkinsons patients, where they are expected to make dopamine and protect the remaining dopamine-making neurons. They are derived from unfertilized, or parthenogenetic, human egg cells, made to grow without fertilization.

Interim data from tests in primates are expected in March, with final results later in the year. The Investigational New Drug application, or IND, is expected to be filed a short while thereafter, Craw said. Filing before years end would be a stretch, Craw said; the filing is more likely to take place in early 2015.

Shares of International Stem Cell closed Tuesday after the announcement at 24 cents, up 7 percent for the day.

The company is working with outside scientists, including D. Eugene Redmond Jr., who is leading a pharmacology/toxicology study. Parkinsons expert Mark Stacy at Duke University will lead the clinical trial. Evan Y. Snyder, a stem cell expert at Sanford-Burnham Medical Research Institute, assists as a scientific adviser.

The companys approach is similar to one being studied by scientists at The Scripps Research Institute led by Jeanne Loring. Moreover, both are expected to ask approval to begin trials around the same time.

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PROPOSED STEM CELL TREATMENT ON TRACK

CardioCell begins 2 heart stem cell trials

By Stem Cell Treatment

CardioCell has begun two new clinical trials of its stem cell treatment for recent heart attack patients, the San Diego company said Wednesday.

A Phase 3 trial has started in Kazakhstan and a Phase 2a trial in the United States, said privately held CardioCell. The stem cells are grown under low oxygen conditions, similar to the natural environment of stem cells in the body, said cardiologist Stephen Epstein, a scientific advisor.

Stem cells grown under higher levels of oxygen common in laboratory environments act differently than those grown in low oxygen levels, which may reduce their regenerative abilities, said Epstein, director of translational and vascular biology research at MedStar Heart Institute in Washington, D.C. Moreover, these cells tolerate ischemia, a reduced blood supply that limits the availability of oxygen and nutrients. Since heart attacks are by definition caused by ischemia, that tolerance should help the cells survive long enough to help, Epstein said.

The stem cells appear to help by producing chemicals that stimulate heart regeneration, Epstein said.

The stem cells are of a type called mesenchymal, taken from bone marrow. They were produced by Stemedica, another San Diego stem cell company, which spun off CardioCell.

More information about the U.S. trial, including eligibility criteria, is available at utsandiego.com/cardiocell. More information about CardioCell is available at http://stemcardiocell.com.

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CardioCell begins 2 heart stem cell trials

Intl. Stem Cell readies for Parkinson's study

By Stem Cell Treatment

A proposed Parkinson's disease treatment from stem cells is on track for an application to be filed with federal regulators around the start of 2015, International Stem Cell Corp. said Tuesday.

The Carlsbad-based company said the U.S. Food and Drug Administration had met with researchers for guidance on what steps need to be taken before filing an application. The meeting went about as expected, said Simon Craw, executive vice president. Ongoing animal studies must be completed, along with safety testing. FDA officials discussed details such as the number of animals to be tested and how the safety studies are to be conducted, Craw said.

International Stem Cell's treatment consists of progenitor cells that mature into neural cells, including those making the neurotransmitter dopamine. These neurons are destroyed in the disease, causing progressive paralysis.

The progenitor cells are to be implanted into the brains of Parkinson's patients, where they are expected to make dopamine and protect the remaining dopamine-making neurons. They are derived from unfertilized, or parthenogenetic, human egg cells, made to grow without fertilization.

Human parthenogenetic neural stem cells in the process of differentiating into dopamine-producing neurons. / International Stem Cell Corp.

Interim data from tests in primates are expected in March, and final results later in the year. The Investigational New Drug application, or IND, is expected to be filed a short while thereafter, Craw said. Filing before year's end "would be a stretch," Craw said; the filing is more likely to take place in early 2015.

Shares of International Stem Cell closed Tuesday after the announcement at 24 cents, up 7 percent for the day. The company is working with outside scientists; including D. Eugene Redmond Jr., who is leading a pharmacology/toxicology study. Parkinson's expert Mark Stacy at Duke University will lead the clinical trial. Evan Y. Snyder, a stem cell expert at Sanford-Burnham Medical Research Institute, assists as a scientific advisor.

The company's approach is similar to one being studied by scientists at The Scripps Research Institute led by Jeanne Loring. Moreover, both are expected to ask approval to begin trials around the same time.

Loring's group gets its cells from the patients to be treated, "reprogrammed" back to an embryonic-like state and called induced pluripotent stem cells, then differentiated into the neural progenitor cells. That treatment's main advantage is the use of the patients' own or autologous cells, expected to minimize any possible immune reaction.

The two groups know each other. Craw said International Stem Cell has hired some of Loring's students, and they have collaborated on some research.

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Intl. Stem Cell readies for Parkinson's study

Acid-Bath Stem Cell Study under Investigation

By Stem Cell Treatment

A research institute is launching an inquiry after allegations of irregularities in two blockbuster papers

The controversial work involved a mouse embryo injected with cells made pluripotent through stress. Credit:Haruko Obokata

A leading Japanese research institute has opened an investigation into a groundbreaking stem-cell study after concerns were raised about its credibility.

The RIKEN center in Kobe announced on Friday that it is looking into alleged irregularities in the work of biologist Haruko Obokata, who works at the institution. She shot to fame last month as the lead author on two paperspublished inNature that demonstrated a simple way to reprogram mature mice cells into an embryonic state by simply applying stress, such as exposure to acid or physical pressure on cell membranes. The RIKEN investigation follows allegations on blog sites about the use of duplicated images in Obokatas papers, and numerous failed attempts to replicate her results.

Cells in an embryonic state can turn into the various types of cells that make up the body, and are therefore an ideal source of patient-specific cells. They can be used to study the development of disease or the effectiveness of drugs and could also be transplanted to regenerate failing organs. A consistent and straightforward path to reprogramming mature cells was first demonstrated in 2006, when a study showed that the introduction of four genes could switch the cells into an embryonic form known as induced pluripotent stem (iPS) cells. The introduction of genes, however, introduces uncertainties about the fidelity of the cells, and Obokatas reports that the feat could be done so simply were met with awe, and a degree of scepticism (see 'Acid bath offers easy path to stem cells').

That scepticism deepened last week when blogs such asPubPeer started noting what seem to be problems in the twoNaturepapers and in an earlier paper from 2011, which relates to the potential of stem cells in adult tissues. In the 2011 paper, on which Obokata is first author, a figure showing bars meant to prove the presence of a certain stem-cell marker appears to have been inverted and then used to show the presence of a different stem-cell marker. A part of that same image appears in a different figure indicating yet another stem-cell marker. The paper contains another apparent unrelated duplication.

The corresponding author of that study, Charles Vacanti, an anaesthesiologist at Harvard Medical School in Boston, toldNaturethat he learned only last week of a mix up of some panels. He has already contacted the journal to request a correction. It certainly appears to have been an honest mistake [that] did not affect any of the data, the conclusions or any other component of the paper, says Vacanti.

The problems in the two recentNaturepapers, on both of which Obokata is a corresponding author (Vacanti is a co-author on both, and corresponding author on one), also relate to images. In one paper, one of the sections in a genomic analysis in the first figure appears to be spliced in. In the other paper, images of two placentas meant to be from different experiments look strikingly similar.

Teruhiko Wakayama, a cloning specialist at Yamanashi University in Yamanashi prefecture, is a co-author on both of the papers and took most of the placental images. He admits that the two look similar but says it may be a case of simple confusion. Wakayama, who left RIKEN during the preparation of the manuscript, says he sent more than a hundred images to Obokata and suggests that there was confusion over which to use. He says he is now looking into the problem.

The scepticism has been inflamed by reports of difficulty in reproducing Obakatas latest results. None of ten prominent stem-cell scientists who responded to a questionnaire fromNaturehas had success. A blog soliciting reports from scientists in the fieldreports eight failures. But most of those attempts did not use the same types of cells that Obokata used.

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Acid-Bath Stem Cell Study under Investigation

Human stem cell research: all viewpoints

By Stell Cell Research

Sponsored link.

Stem cells are a special form of human life: they are alive and contain human DNA. They have a unique feature in that they can be coaxed into developing into some or all of the 220 cell types found in the human body. Eventually, stem cells may be routinely used by doctors to generate new organs or new replacement body parts for people: They might become a new pancreas to cure a person with diabetes, or new nerve cells to cure a paralized person, etc.

There are three types of stem cells:

"...reprogrammed a dozen cell types, including those from the brain, skin, lung and liver, hinting that the method will work with most, if not all, cell types. On average, she says, 25% of the cells survive the stress and 30% of those convert to pluripotent cells already a higher proportion than the roughly 1% conversion rate of iPS cells." 1

The National Institutes of Health web site states:

"To realize the promise of novel cell-based therapies for such pervasive and debilitating diseases, scientists must be able to manipulate stem cells so that they possess the necessary characteristics for successful differentiation, transplantation, and engraftment. The following is a list of steps in successful cell-based treatments that scientists will have to learn to control to bring such treatments to the clinic. To be useful for transplant purposes, stem cells must be reproducibly made to:

Also, to avoid the problem of immune rejection, scientists are experimenting with different research strategies to generate tissues that will not be rejected.

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Human stem cell research: all viewpoints

Doctors use stem cell therapy to treat lung diseases …

By Stem Cell Doctors

Tampa, Florida --It's the third leading cause of death in the U.S.You've probably even seen ads for treating COPD, but you may not even know what it is.

Chronic Obstructive Pulmonary Disease is a progressive lung disease likely caused by smoking, but air pollution can also be a factor. According to the American Lung Association, women are 37 percent more likely to have it than men and since there's no cure, people will do anything to breathe a little easier.

Doctors atthe Lung Institute in Tampa are using a lung patient's own stem cells to help treat COPD, emphysema and pulmonary fibrosis byrepairing damaged tissue. Like most patients seeking help, 70-year-old Daniel Odulio depends on an oxygen tank. He flew here all the way from The Philippines to improve his life.

The Lung Institute told 10 News the doctorsuse thelatest FDA-approved commercially available equipment for collecting and isolating stem cells using patients' own blood and adipose fat. They say theinnovative stem cell therapy won't be rejected because the doctors use the patients' own cells.In some cases, patients are able to get rid of their oxygen tanks altogether.

10 News

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Doctors use stem cell therapy to treat lung diseases ...

Older Muscle Stem Cells Rejuvenated to Function Like Younger Cells, May Help Elderly Repair Muscle

By Stem Cell Medicine

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Health & Medicine for Senior Citizens

Older Muscle Stem Cells Rejuvenated to Function Like Younger Cells, May Help Elderly Repair Muscle

Stanford researchers pinpoint why normal aging is accompanied by a diminished ability to regain strength and mobility after muscle injury

By Krista Conger

Feb. 17, 2014 - Researchers at the Stanford University School of Medicine have pinpointed why normal aging is accompanied by a diminished ability to regain strength and mobility after muscle injury: Over time, stem cells within muscle tissues dedicated to repairing damage become less able to generate new muscle fibers and struggle to self-renew.

In the past, its been thought that muscle stem cells themselves dont change with age, and that any loss of function is primarily due to external factors in the cells environment, said Helen Blau, PhD, the Donald and Delia B. Baxter Foundation Professor.

However, when we isolated stem cells from older mice, we found that they exhibit profound changes with age. In fact, two-thirds of the cells are dysfunctional when compared to those from younger mice, and the defect persists even when transplanted into young muscles.

Blau and her colleagues also identified for the first time a process by which the older muscle stem cell populations can be rejuvenated to function like younger cells. Our findings identify a defect inherent to old muscle stem cells, she said. Most exciting is that we also discovered a way to overcome the defect. As a result, we have a new therapeutic target that could one day be used to help elderly human patients repair muscle damage.

Blau, a professor of microbiology and immunology and director of Stanfords Baxter Laboratory for Stem Cell Biology, is the senior author of a paper describing the research, published online Feb. 16 in Nature Medicine. Postdoctoral scholar Benjamin Cosgrove, PhD, and former postdoctoral scholar Penney Gilbert, PhD, now an assistant professor at the University of Toronto, are the lead authors.

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Older Muscle Stem Cells Rejuvenated to Function Like Younger Cells, May Help Elderly Repair Muscle

Scientists 'rejuventate' stem cells in elderly mice to repair muscles

By Stem Cell Medicine

PALO ALTO, Calif., Feb. 17 (UPI) -- In an experiment with mice, U.S. scientists say they've enabled muscle recovery in elderly mice by rejuvenating stem cells within their muscle tissue.

Normal aging is accompanied by a diminished ability to regain strength and mobility after muscle injury because over time stem cells within muscle tissues dedicated to repairing damage become less able to generate new muscle fibers and struggle to self-renew, researchers at Stanford University reported Sunday.

"In the past, it's been thought that muscle stem cells themselves don't change with age, and that any loss of function is primarily due to external factors in the cells' environment," Helen Blau of the university's school of medicine said.."However, when we isolated stem cells from older mice, we found that they exhibit profound changes with age. In fact, two-thirds of the cells are dysfunctional when compared to those from younger mice, and the defect persists even when transplanted into young muscles."

However, Blau and her colleagues say they've identified for the first time a process by which the older muscle stem cell populations can be rejuvenated to function like younger cells.

"Our findings identify a defect inherent to old muscle stem cells," she said. "Most exciting is that we also discovered a way to overcome the defect. As a result, we have a new therapeutic target that could one day be used to help elderly human patients repair muscle damage."

The researchers used drugs to block elevated biological activity within the stem cells that causes them to degenerate into non-stem, muscle progenitor cells.

When transplanted back into the animal, the treated, rejuvenated stem cells migrate to their natural niches and provide a long-lasting stem cell reserve to contribute to repeated demands for muscle repair, they researchers said.

"In mice, we can take cells from an old animal, treat them for seven days -- during which time their numbers expand dramatically, as much as 60-fold -- and then return them to injured muscles in old animals to facilitate their repair," Blau said.

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Scientists 'rejuventate' stem cells in elderly mice to repair muscles

Kerry Simon returns from first round of stem-cell trials at Mayo Clinic, plans Feb. 27 benefit

By Stem Cell Clinic

David Becker/WireImage

Doug Bell (Heraea), Eric Ripert, Anthony Bourdain, Barry Dakake (N9NE Steakhouse) and Kerry Simon (Simon) at the Palms on Saturday, Feb. 9,2013.

By Robin Leach (contact)

Monday, Feb. 17, 2014 | 6 p.m.

Iron Chef winner Kerry Simon is back home after his first week of stem-cell treatments at the Mayo Clinic. He had an emotional homecoming with his restaurant partner Elizabeth Blau and Europes leading Multiple Systems Atrophy scientist, Dr. Gregor Wenning from Austria, who had been meeting with Kerrys physician, Dr. Ryan Walsh from the downtown Cleveland Clinic Lou Ruvo Center for Brain Health.

Kerry underwent two days of stem-cell injections at the base of his spine that had been harvested from him in a December visit to Mayo in Rochester, Minn. He told me they were exhausting and painful and that his return to Las Vegas over the weekend was delayed a day while fighting a low-grade fever.

It is unknown if the treatments will benefit him in the crippling disease for which there is no cure or treatment. He will return to Minnesota in March for two months of additional stem-cell surgeries and clinical trials.

First up, though, is his celebrity chef fundraiser and rock concert at the Brain Center on Feb. 27. An after-party for the food and music stars will follow at his restaurant Simon in Palms Place. For information and tickets, please go to KeepMemoryAlive.org.

Sammy Hagar, Alice Cooper, Vince Neil and Slash are among the performers, with Oscar-nominated actor and comedian Bill Murray as MC. Jean-Georges Vongerichten, Daniel Boulud and Charlie Palmer are among the 15 guest chefs.

Meantime, the Las Vegas hospitality industry is helping Kerrys fundraiser with auction items that Christian Kohlberg will sell. They include chef dinners from Mario Batali, Thomas Keller and Todd English and celebrity chef restaurant dinners from Guy Fieri, Emeril Lagasse and Wolfgang Puck.

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Kerry Simon returns from first round of stem-cell trials at Mayo Clinic, plans Feb. 27 benefit

Halifax students help spark interest in stem cell donation

By Stem Cell Clinic

Right now there are at least 40 Canadians hoping that, somewhere, healthy young black men with their particular genetic markers will sign up to be stem cell donors.

To me, its not something you just think about, its something you do. Its pretty simple, says 18-year-old Emmanuel John.

The Grade 12 student at Halifax West was volunteering Monday at his high school, helping register potential donors and taking swabs.

You get a couple tests and you may be a potential donor, he said. If you are, you can potentially save someones life.

The registration and swab event was put on by Canadian Blood Services OneMatch Stem Cell and Marrow Network. The network tries to match donors with people suffering from blood diseases or cancers like sickle-cell anemia and leukemia, said OneMatch co-ordinator Hailu Mulatu.

There are 750 Canadians in need of a stem cell transplant, but African-Canadians who make up just under one per cent of registered potential donors are under-represented in the national registry, said Mulatu.

Finding a donor and patient match is very difficult. And, because patients and donors must share similar genetic markers, a successful match will only be found among people of the same ethnic origin. Only about 25 per cent of donors are found in a patients family.

Ideal candidates are healthy individuals ranging in age from 17 to 35. Men are more likely to be successful donors than women, Mulatu said.

Organizers chose African Heritage Month as a good time to raise the awareness of the need for more African-Canadian donors.

By noon Monday, the majority of students turning out to the registration event were female although they appeared to be from a wide variety of cultural backgrounds.

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Halifax students help spark interest in stem cell donation

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