Category Archives: Stem Cells

The Food and Drug Administration has informed the Sugar Land company involved in Gov. Rick Perry's adult stem-cell procedure that it is illegally marketing an unlicensed drug.

In a warning letter, the FDA gave Celltex Therapeutics Corp. 15 business days to submit a plan to address the agency's concerns, including correcting previously cited manufacturing problems. The letter said that failure to respond promptly could result in seizure or injunction by the FDA.

"Based on (our) information, your product violates the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act," says the letter, sent on Sept. 24 and publicly posted Tuesday.

The letter comes about six months after the FDA made a 10-day inspection of the facilities where Celltex banks and grows stem cells taken from prospective patients. The agency subsequently filed a report, obtained by the Chronicle in June, detailing dozens of manufacturing deficiencies, from incorrectly labeled products to failed sterility tests.

The new warning letter reiterates those problems and asks for more information about them.

David Eller, Celltex's CEO, was unavailable Tuesday, but a public relations official said the company on Wednesday would make available a redacted copy of its letter to the FDA.

In a previous news release, Eller said Celltex "respectfully but firmly" disagreed with the FDA's position that its process causes the cells to be considered biological drugs and thus subject to the federal agency's regulations. Biological drugs involve living human cells, as opposed to chemically synthesized drugs.

"We are considering all options as we work with the agency toward a resolution," Eller said in the release.

Adult stem cells multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have recently shown promise for tissue repair in other diseases, though most scientists in the field consider them not ready for mainstream use.

Treatment, at a price

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FDA issues warning letter to local stem cell company

The nuclei of brain stem cells in some Parkinson's patients become misshapen with age. The discovery opens up new ways to target the disease.

Nubby nucleus: Brain cells from a deceased Parkinsons patient have deformed nuclei (bottom) compared with normal brain cells from an individual of a similar age. Merce Marti and Juan Carlos Izpisua Belmonte

Stem cells in the brains of some Parkinson's patients are increasingly damaged as they age, an effect that eventually diminishes their ability to replicate and differentiate into mature cell types. Researchers studied neural stem cells created from patients' own skin cells to identify the defects. The findings offer a new focus for therapeutics that target the cellular change.

The report, published today in Nature, takes advantage of the ability to model diseases in cell culture by turning patient's own cells first into so-called induced pluripotent stem cells and then into disease-relevant cell typesin this case, neural stem cells. The basis of these techniques was recognized with a Nobel Prize in medicine last week.

The authors studied cells taken from patients with a heritable form of Parkinson's that stems from mutations in a gene. After growing several generation of neural stem cells derived from patients with that mutation, they saw the cell nuclei start to develop abnormal shapes. Those abnormalities compromise the survival of the neural stem cells, says study coauthor Ignacio Sancho-Martinez of the Salk Institute for Biological Studies in La Jolla, California.

Today's study "brings to light a new avenue for trying to figure out the mechanism of Parkinson's," says Scott Noggle of the New York Stem Cell Foundation. It also provides a new set of therapeutic targets: "Drugs that target or modify the activity [of the gene] could be applicable to Parkinson's patients. This gives you a handle on what to start designing drug screens around."

The strange nuclei were also seen in patients who did not have a known genetic basis for Parkinson's disease. The authors suggest this indicates that dysfunctional neural stem cells could contribute to Parkinson's. While that conclusion is "highly speculative," says Ole Isacson, a neuroscientist at Harvard Medical School, the study demonstrates the "wealth of data and information that we now can gain from iPS cells."

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Stem Cells Reveal Defect in Parkinson's Cells

The nuclei of brain stem cells in some Parkinson's patients become misshapen with age. The discovery opens up new ways to target the disease.

Nubby nucleus: Brain cells from a deceased Parkinsons patient have deformed nuclei (bottom) compared with normal brain cells from an individual of a similar age. Merce Marti and Juan Carlos Izpisua Belmonte

Stem cells in the brains of some Parkinson's patients are increasingly damaged as they age, an effect that eventually diminishes their ability to replicate and differentiate into mature cell types. Researchers studied neural stem cells created from patients' own skin cells to identify the defects. The findings offer a new focus for therapeutics that target the cellular change.

The report, published today in Nature, takes advantage of the ability to model diseases in cell culture by turning patient's own cells first into so-called induced pluripotent stem cells and then into disease-relevant cell typesin this case, neural stem cells. The basis of these techniques was recognized with a Nobel Prize in medicine last week.

The authors studied cells taken from patients with a heritable form of Parkinson's that stems from mutations in a gene. After growing several generation of neural stem cells derived from patients with that mutation, they saw the cell nuclei start to develop abnormal shapes. Those abnormalities compromise the survival of the neural stem cells, says study coauthor Ignacio Sancho-Martinez of the Salk Institute for Biological Studies in La Jolla, California.

Today's study "brings to light a new avenue for trying to figure out the mechanism of Parkinson's," says Scott Noggle of the New York Stem Cell Foundation. It also provides a new set of therapeutic targets: "Drugs that target or modify the activity [of the gene] could be applicable to Parkinson's patients. This gives you a handle on what to start designing drug screens around."

The strange nuclei were also seen in patients who did not have a known genetic basis for Parkinson's disease. The authors suggest this indicates that dysfunctional neural stem cells could contribute to Parkinson's. While that conclusion is "highly speculative," says Ole Isacson, a neuroscientist at Harvard Medical School, the study demonstrates the "wealth of data and information that we now can gain from iPS cells."

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Parkinson's cells

Public release date: 17-Oct-2012 [ | E-mail | Share ]

Contact: Dean Forbes dforbes@fhcrc.org 206-667-2896 Fred Hutchinson Cancer Research Center

SEATTLE One of the world's leading bone marrow transplant experts is recommending a significant change to current transplant practice for patients who need marrow or adult stem cells from an unrelated donor to treat hematologic malignancies. Fred Appelbaum, M.D., director of the Clinical Research Division at Fred Hutchinson Cancer Research Center, asserts that bone marrow not circulating, peripheral blood, which is the current norm should be the source for unrelated donor adult stem cells for most patients who require a transplant. The reason: because there is less incidence of chronic graft-versus-host disease (GVHD), which can be a debilitating side effect of transplantation.

Appelbaum called for the change in an Oct. 18 editorial in The New England Journal of Medicine in response to a new study, published in the same issue, which compared survival rates and side effects of treating patients with hematopoietic adult stem cells derived from bone marrow versus circulating peripheral blood. The study found a higher incidence of chronic GVHD 53 percent when peripheral blood was the source of stem cells for transplant versus 41 percent when bone marrow is the source.

"For the majority of unrelated transplants following a standard high-dose preparative regimen, bone marrow should be used since survival is equivalent with the two sources but the incidence of chronic graft-versus-host disease, which can be a debilitating complication, is significantly less with marrow," Appelbaum wrote.

GVHD is a common side effect in people who receive cells from an unrelated donor. It occurs when the transplanted cells recognize the recipient's tissues as foreign and attack the tissues. This can cause a variety of problems, including skin rashes, liver problems and diarrhea. Chronic GVHD can develop any time between three months and three years after the transplant and can range from mild to serious in intensity.

Appelbaum said that stem cells derived from peripheral blood should only be used for the minority of patients in whom the benefits outweigh the risks. These include patients in need of rapid engraftment, such as those with life-threatening infections, or patients at high risk for graft rejection, such as those who receive reduced-intensity conditioning that does not include intensive chemotherapy.

For the past 10 years peripheral blood has been the norm as a source of matched related and matched unrelated adult stem cells for transplant because, despite the higher risk of GVHD, they are easier to harvest from the donor, they can be stimulated to grow in large numbers prior to harvesting, and they engraft, or set up shop, quickly inside the recipient's body.

The potential impact if such a practice change were widely implemented is large. Currently, about 75 percent of unrelated donor transplants are done using stem cells that are collected from the peripheral blood of donors. About 70 percent of all patients who undergo a life-saving transplant to treat blood cancers such as leukemia require an unrelated donor. Collecting adult stem cells from bone marrow is a more invasive process than collecting them from the bloodstream.

According to Appelbaum, about 5,500 unrelated donor transplants were performed in the United States last year. More than 20 million potential unrelated donors are typed and listed in registries in the Americas, Europe and Asia.

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Leading bone marrow transplant expert recommends significant change to current practice

An important issue pushed into the background.

Stem cell issues: still important issues. Photograph: Getty Images

In a US election year dominated by economic issues, research using human embryonic stem cells (hESC) has received far less attention in 2012 than in previous election years just another social debate pushed into the background, despite its ethical controversy and the fact that it could have major implications for the treatment of conditions as serious and widespread as diabetes, cancer, heart disease and dementia.

Although stem cell research isn't exactly on top of this year's election agenda, the result when America goes to the polls on 6 November could have a major impact on hESC research in the US. The main issue at hand is not whether embryonic stem cell research should be banned both Obama and Romney agree that this research is legal but whether it should be federally funded through the National Institutes of Health (NIH).

President Obama has effectively made his position clear during his time in office. In 2009, he reversed a directive from his predecessor George W Bush that denied federal funding to research on any stem cells created after 2001, limiting researchers to the 21 stem cell lines (a family of constantly dividing cells) that had been derived from embryos up to that point. Obama's legislation re-opened the 1,000 or more stem cell lines that have been created since then to federally-funded research, a move welcomed by the scientific community and condemned by pro-life campaigners and conservative Republicans.

In reality, despite Obama's 2009 legislation, under the Dickey-Wicker amendment introduced in 1996 it is still illegal in the US to pursue any research that involves the creation, destruction or discarding of human embryos, meaning that although American scientists can conduct research on stem cell lines derived from embryos, they are barred from using embryos to create their own lines. The Dickey-Wicker amendment remains an obstacle to embryonic stem cell research in the US and it's unclear if the president would have the clout to do away with it if re-elected.

Romney's personal view on hESC seems to broadly follow the pro-life stance of his party; he supports stem cell research in general, but opposes the destruction of embryos for the purpose. In a Republican presidential candidates' debate for the last election in 2007, Romney stated that he wouldn't use federal funds to finance hESC research. This would essentially take the US back to the same situation as under George W Bush, and there's no reason to think that Romney has changed his position between 2007 and now.

The Republican candidate has consistently extolled the benefits of adult and umbilical cord stem cells, which, he asserts, provide the benefits of creating pluripotent cells without the "moral shortcut" of destroying an embryo in the process. Alternatives to embryonic stem cell research are Romney's perfect political solution, allowing him to appear to support stem cell research without losing the religious right by excusing the destruction of embryos.

From a scientific standpoint, his position is less tenable. Researchers have said that the development of non-embryonic stem cell types is actually dependent on embryonic stem cell research as a complementary process. So by plugging adult stem cell research alternatives as the exclusive answer to the field's ethical issues, Romney may be unwittingly damaging their development by depriving researchers of important side-by-side embryonic research.

Whatever the outcome of the elections on 6 November, the US is unlikely to live up to its stem cell research potential when compared to world leaders in the field. If Obama wins, there will at least be federal funding to study existing embryonic stem cells, but the Dickey-Wicker amendment will maintain the ban on creating new stem cell lines. If Romney turns the tide and emerges on top, American stem cell researchers will likely have to suffer through four more years in the unfunded wilderness.

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Stem cells: this election's neglected child

Washington, October 17 (ANI): Researchers believe they have discovered stem cells that play a decisive role in new blood vessel growth.

If the researchers at the University of Helsinki, Finland, learn to isolate and efficiently produce these stem cells found in blood vessel walls, the cells offer new opportunities in the treatment of cardiovascular diseases, cancer and many other diseases.

The growth of new blood vessels, also known as angiogenesis, is needed in adults when repairing damaged tissue or organs.

Unfortunately, malignant tumours are also capable of growing new blood vessels to receive oxygen and nutrients. In other words, the treatment of diseases would benefit from two types of methods - ones that help launch the process of angiogenesis and ones that make it possible to prevent the process.

Medications that prevent the growth of new blood vessels have already been introduced, but their effectiveness and long-term efficacy leave much to be desired.

For more than a decade, Adjunct Professor Petri Salven from the University of Helsinki has studied the mechanisms of angiogenesis to discover how blood vessel growth could be prevented or accelerated effectively.

He has examined the birth and origin of endothelial cells, which form the thin layer that lines the interior surface of blood vessels. Endothelial cells are necessary for new blood vessel growth. Where do these highly diversified cells come from? Can their production be prevented or increased?

For a long time, it was assumed that new cells in the blood vessel walls of an adult originate in the bone marrow. In an article published in the PNAS journal in 2008, Salven's research team showed that such stem cells were not found in bone marrow.

Now Salven is ready to reveal where these mysterious stem cells originate.

"We succeeded in isolating endothelial cells with a high rate of division in the blood vessel walls of mice. We found these same cells in human blood vessels and blood vessels growing in malignant tumours in humans. These cells are known as vascular endothelial stem cells, abbreviated as VESC. In a cell culture, one such cell is able to produce tens of millions of new blood vessel wall cells," Salven said.

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New blood-vessel-generating cells with therapeutic potential discovered

ScienceDaily (Oct. 16, 2012) Researchers at the University of Helsinki, Finland, believe they have discovered stem cells that play a decisive role in new blood vessel growth. If researchers learn to isolate and efficiently produce these stem cells found in blood vessel walls, the cells offer new opportunities in the treatment of cardiovascular diseases, cancer and many other diseases.

The study will be published Oct. 16, 2012 in the online journal PLOS Biology.

The growth of new blood vessels, also known as angiogenesis, is needed in adults when repairing damaged tissue or organs. Unfortunately, malignant tumours are also capable of growing new blood vessels to receive oxygen and nutrients. In other words, the treatment of diseases would benefit from two types of methods: ones that help launch the process of angiogenesis and ones that make it possible to prevent the process. Medications that prevent the growth of new blood vessels have already been introduced, but their effectiveness and long-term efficacy leave much to be desired.

For more than a decade, Adjunct Professor Petri Salvn from the University of Helsinki has studied the mechanisms of angiogenesis to discover how blood vessel growth could be prevented or accelerated effectively. He has examined the birth and origin of endothelial cells, which form the thin layer that lines the interior surface of blood vessels. Endothelial cells are necessary for new blood vessel growth. Where do these highly diversified cells come from? Can their production be prevented or increased?

For a long time, it was assumed that new cells in the blood vessel walls of an adult originate in the bone marrow. In an article published in the Proceedings of the National Academy of Sciences (PNAS) in 2008, Salvn's research team showed that such stem cells were not found in bone marrow.

Now Salvn is ready to reveal where these mysterious stem cells originate. His team's new study will be published in the PLOS Biology journal on 16 October 2012.

"We succeeded in isolating endothelial cells with a high rate of division in the blood vessel walls of mice. We found these same cells in human blood vessels and blood vessels growing in malignant tumours in humans. These cells are known as vascular endothelial stem cells, abbreviated as VESC. In a cell culture, one such cell is able to produce tens of millions of new blood vessel wall cells," Salvn explains.

"Our study shows that these important stem cells can be found as single cells among ordinary endothelial cells in blood vessel walls. When the process of angiogenesis is launched, these cells begin to produce new blood vessel wall cells."

The effects of new endothelial stem cells have also been tested in mice. The results show that the growth of new blood vessels weakens and the growth of malignant tumours slows if the amount of these cells in the organism is below normal. Correspondingly, a high number of new blood vessels quickly emerge where new stem cells are implanted.

Identifying stem cells among other blood vessel wall cells is challenging and time-consuming. Salvn and his team managed to identify a few molecular surface structures that make it easier to trace these stem cells. However, the efficiency of the identification process needs to be enhanced.

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New blood-vessel-generating cell with therapeutic potential discovered