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Prosecutors say Stamina treatment hurt, not helped, patients

By Stem Cell Treatment

Charges of criminal association may be filed in medical case

(ANSA) - Turin, April 23 - Not only was a discredited stem-cell treatment useless, investigations found that it actually hurt a number of patients, prosecutors said Wednesday as they concluded a probe of 20 suspects involved in the Stamina treatment. That includes Davide Vannoni, founder of the Stamina Foundation, who may face indictment in the case now that prosecutors have finished a lengthy probe. Charges could include criminal association to commit aggravated fraud and administration of dangerous drugs, according to prosecutors whose probe examined the treatment of slightly more than 100 patients and found "adverse reactions" in some cases. Another 37 donors of stem cells used in the controversial treatment, rejected by the health ministry, were examined during the investigation. According to prosecutors, Vannoni and other suspects "falsely pretended" to patients and their families that there was "high chance" of recovery from serious illness if they agreed to the Stamina treatment. Vannoni, a former psychology lecturer who was indicted earlier this year for alleged attempted fraud against the Piedmont Region, had also tried to discredit health officials and the national health system while raising social tension, according to prosecutors. Earlier this month, hospitals in Italy that used the discredited stem-cell treatment announced they had suspended the program. That followed announcements last fall by Italy's health ministry that the Stamina Foundation - the nonprofit foundation that developed the treatment - would not be allowed to test it on humans. The foundation was also stripped of its non-profit status after a study found its treatment was "ignorant of stem-cell biology". Health Minister Beatrice Lorenzin said she was "not surprised" by the outcome of the investigation. "It is a story that had Italians holding their breath with many concerns and anxieties," she said. "It is important that (the findings) come out clearly, because there are victims, the thousands of people who believed they could have a cure," she said. The Stamina treatment involves extracting bone-marrow stem cells from a patient, turning them into neurons by exposing them to retinoic acid for two hours, and injecting them back into the patient. Supporters of the therapy thought it could be a cure for fatal degenerative nerve diseases such as spinal muscular atrophy, while detractors said it was devoid of scientific merit. A panel of experts appointed by Italy's health ministry said in January it found the therapy seriously lacking in both premise and practice. Their report cited "serious imperfections and omissions in the Stamina protocol, including conceptual errors and an apparent ignorance of stem-cell biology". The Stamina Foundation had asked for 500,000 euros of funding to develop a stem-cell laboratory, a request that earlier prosecutors had argued was fraudulent because the efficacy of the treatment has been "completely disproved".

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Prosecutors say Stamina treatment hurt, not helped, patients

Study finds long-term survival of human neural stem cells transplanted into primate brain

By Stem Cell Treatment

PUBLIC RELEASE DATE:

23-Apr-2014

Contact: Robert Miranda cogcomm@aol.com Cell Transplantation Center of Excellence for Aging and Brain Repair

Putnam Valley, NY. (Apr. 23 2014) A team of researchers in Korea who transplanted human neural stem cells (hNSCs) into the brains of nonhuman primates and assessed cell survival and differentiation after 22 and 24 months found that the hNSCs had differentiated into neurons at 24 months and did not cause tumors.

The study will be published in a future issue of Cell Transplantation but is currently freely available on-line as an unedited early e-pub at: http://www.ingentaconnect.com/content/cog/ct/pre-prints/content-ct1117Antonucci2.

The hNSCs were labeled with magnetic nanoparticles to enable them to be followed by magnetic resonance imaging (MRI). They did not use immunosuppressants. According to the researchers, their study is the first to evaluate and show the long-term survival and differentiation of hNSCs without the need for immunosuppression.

The researchers concluded that hNSCs could be of "great value" as a source for cell replacement and gene transfer for the treatment of Parkinson's disease, Huntington's disease, Alzheimer's disease, amyotrophic lateral sclerosis (ALS), spinal cord injury and stroke.

"Stroke is the fourth major cause of death in the US behind heart failure, cancer, and lower respiratory disease," said study co-author Dr. Seung U. Kim of University of British Columbia Hospital's department of neurology in Canada. "While tissue plasminogen activator (tPA) treatment within three hours after a stroke has shown good outcomes, stem cell therapy has the potential to address the treatment needs of those stroke patients for whom tPA treatment was unavailable or did not help."

Dr. Kim and colleagues in Korea grafted magnetic particle-labeled hNSCs into the brains of laboratory primates and evaluated their performance to assess their survival and differentiation over 24 months. Of particular interest was determining their ability to differentiate into neurons and to determine whether the cells caused tumorogenesis.

"We injected hNSCs into the frontal lobe and the putamen of the monkey brain because they are included in the middle cerebral artery (MCA) territory, which is the main target in the development of the ischemic lesion in animal stroke models," commented Dr. Kim. "Thus, research on survival and differentiation of hNSCs in the MCA territory should provide more meaningful information to cell transplantation in the MCA occlusion stroke model."

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Study finds long-term survival of human neural stem cells transplanted into primate brain

Probe finished in controversial stemcell therapy

By Stem Cell Treatment

Next step by prosecutors could be indictments

(ANSA) - Turin, April 23 - Prosecutors said Wednesday they have completed their investigation into a controversial stem-cell treatment involving 20 individuals, including Davide Vannoni, founder of the Stamina Foundation. The notice means prosecutors could now proceed to indictments in the case that may involve charges of fraud. Earlier this month, hospitals in Italy that used the discredited stem-cell treatment announced they have suspended the program. That followed announcements last fall by Italy's health that the Stamina Foundation - the nonprofit foundation that developed the treatment - would not be allowed to test it on humans. The foundation was also stripped of its non-profit status after a study found its treatment was "ignorant of stem-cell biology". Vannoni, a former psychology lecturer, was indicted earlier this year for alleged attempted fraud against the Piedmont Region. The Stamina Foundation had asked for 500,000 euros of funding to develop a stem-cell laboratory, a request prosecutors had earlier argued was fraudulent because the efficacy of the treatment has been "completely disproved". The Stamina treatment involves extracting bone-marrow stem cells from a patient, turning them into neurons by exposing them to retinoic acid for two hours, and injecting them back into the patient. Supporters of the therapy thought it could be a cure for fatal degenerative nerve diseases such as spinal muscular atrophy, while detractors said it was devoid of scientific merit. A panel of experts appointed by Italy's health ministry said in January it found the therapy seriously lacking in both premise and practice. Their report cited "serious imperfections and omissions in the Stamina protocol, including conceptual errors and an apparent ignorance of stem-cell biology".

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Probe finished in controversial stemcell therapy

Scientists identify cancer specific cell for potential treatment of gastric cancer

By Stem Cell Treatment

PUBLIC RELEASE DATE:

23-Apr-2014

Contact: Kimberley Wang kimberley.wang@nus.edu.sg National University of Singapore

A team of scientists led by a researcher from the Cancer Science Institute of Singapore (CSI Singapore) at the National University of Singapore has identified the cancer specific stem cell which causes gastric cancer. This discovery opens up the possibility of developing new drugs for the treatment of this disease and other types of cancers.

The research group, led by Dr Chan Shing Leng, Research Assistant Professor at CSI Singapore, demonstrated for the first time that a cancer-specific variant of a cell surface protein, CD44v8-10, marks gastric cancer stem cells but not normal cells. Conceptualised by Dr Chan and Associate Professor Jimmy So, a Senior Consultant from the Department of Surgery at the National University Hospital Singapore, the study is also the first to be conducted with human gastric tissue specimens and took five years to complete. This novel study will be published in the research journal Cancer Research, the official journal of American Association of Cancer Research, in May 2014.

Gastric cancer is a major cause of cancer-related deaths worldwide, with low survival and high recurrence rates for patients with advanced disease. New therapies for the treatment of gastric cancer are urgently needed.

How CD44v8-10 serves as a biomarker

Many cancer cell types express high levels of a cell surface protein known as CD44. This protein marks cancer stem cells that are thought to be responsible for resistance to current cancer therapy and tumour relapse. There are many forms of CD44 and the standard form of CD44, CD44s, is found in high abundance on normal blood cells. It was previously not known which form of CD44 is found on cancer stem cells. This is critical as an ideal cancer target should mark only cancer cells but not normal cells.

Research by the team and other scientists in the field has led to the hypothesis that the growth of gastric cancer may be driven by cancer stem cells. In this study, the researchers analysed 53 patient tissue samples in conjunction with patient-derived xenograft models which are derived from intestinal type gastric cancer. The team is one of the few groups in the world to have a relatively large collection of patient-derived xenograft models for gastric cancer and the first to use these models for identification of gastric cancer stem cells. A total of eight cancer cell lines were used in this study, including six new cell lines which were established by the researchers.

The scientists discovered a cancer-specific CD44 variant, CD44v8-10 marks gastric cancer stem cells but not normal cells. CD44v8-10 promotes cancer cell growth and it is significantly more abundant in gastric tumour sites compared to normal gastric tissue, which makes it easily detectable. The findings results suggest that CD44v8-10 is an ideal target for developing clinical therapeutics against gastric cancer stem cells. As CD44v8-10 is cancer specific, it may also be used as a biomarker for screening and diagnosis of gastric cancer. This is significant as biomarkers for early detection of gastric cancer are currently not available and doctors rely on endoscopy for the screening and diagnosis of this disease.

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Scientists identify cancer specific cell for potential treatment of gastric cancer

In stem-cell research, health benefits outweigh the risks …

By Stell Cell Research

CONTROVERSIES OVER stem-cell research are so last decade or so it seemed until last week.

For the last few years, the promising field of stem-cell research has focused on a technique that skirts various ethical concerns about the treatment of human embryos and the potential to clone whole human beings. But last week, U.S. and South Korean researchers announced that they went ahead with a different technique, successfully creating stem cells cloned from the normal skin cells of adults. Their work helps to open a new avenue in stem-cell research. But it also could be a step on the way to human reproductive cloning.

Some ethical worries are reasonable, but they are not enough reason to hold back this research.

Since the late 1990s, scientists have held out the prospect of extraordinary new treatments from pluripotent stem cells, which are stem cells that can grow into all sorts of different tissues at researchers urging. Scientists might be able to grow insulin-producing cells for patients with diabetes. People suffering from macular degeneration might not have to lose their sight. There is even the potential to grow whole organs, matched exactly to patients, that could replace diseased ones.

Early research often involved taking stem cells from embryos discarded during in-vitro fertilization therapy. That procedure stoked opposition from people concerned about embryo destruction during scientific experimentation. Then scientists developed a different technique for harvesting stem cells that involved reprogramming adult cells, no embryos involved.

Work on that procedure continues, but there is concern in some quarters that it will not reliably and uniformly produce usable stem cells. So other scientists have been working on something called somatic cell nuclear transfer, which involves taking the nucleus out of a human egg and replacing it with the nucleus from an adult cell. Last weeks announcement came from researchers who had refined the nuclear transfer process and achieved the results they were looking for pluripotent human stem cells.

The procedure is not perfect. It took a lot of eggs to record a few successes. Moreover, it is the sort of technique scientists would use if they were trying to engage in reproductive cloning creating fully formed human beings who are exact genetic copies of other human beings. The question is whether researchers who arent interested in reproductive cloning should be barred from refining the nuclear transfer process lest a rogue scientist decides to try Xeroxing people.

Wed say that they should not be restricted if the method may advance the search for bona fide stem-cell therapies. The potential to directly and significantly reduce human suffering is too great to close off every line of research but the one that carries zero controversy. There is, moreover, a clear ethical distinction between cloning a humans cells in order to redeploy them in medical treatment and growing a genetic copy of a human being. As long as scientists do not cross ethical lines much farther from where they are now lines that Congress could write into federal law researchers should have the flexibility to go in whichever direction is scientifically useful.

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In stem-cell research, health benefits outweigh the risks ...

Stem cell research fuels more debate on cloning

By Stell Cell Research

Karen Weintraub, Special for USA TODAY 5:42 p.m. EDT April 19, 2014

A sheep called Dolly, the world's first clone of an adult mammal, is seen in this undated photo. Dolly, was developed by a team of scientists at the Roslin Institute in Edinburgh, Scotland. A study out this week reported success in cloning a human embryo using a technique similar to the one used to clone Dolly, who was cloned in 1996 and died in 2003.(Photo: AP)

A study published this week has reawakened debate over the government's need to regulate human cloning.

In a paper in the journal Cell Stem Cell, researchers took the nucleus of skin cells from 35 and 75 year old men, and produced cloned human embryos. From those they were able to generate embryonic stem cells, valued because they can then be teased into becoming any tissues the body might need.

The researchers are quick to point out that they would never try to implant that embryo in a woman. Instead, the cells will be used for research purposes with an eye toward developing medical therapies. The promise of stem cells has long been that they could be used to grow tissues the body needs to treat ailments ranging from Parkinson's to spinal cord injuries. Creating stem cells from a cloned embryo presumably would create tissues that wouldn't be rejected by the person who donated skin cells initially.

But advocacy groups on opposite ends of the political spectrum said Friday that the study is a reminder of the need for government to step in before someone tries to extend this technique to engineer a human clone.

Animal cloning has been possible since Dolly the sheep was born in 1996, but human cloning has long been considered nearly as impossible as it is unethical. The new paper, which builds on and confirms a study published last year using a similar technique, resolves technical hurdles along the path to human cloning.

"The science is no longer theoretical," said Jeremy Gruber, president of the Council for Responsible Genetics, a New York City-based bioethics organization. "We need to start putting laws into place to identify where the line should be drawn in terms of governance of these techniques."

Gruber's organization, along with the Berkeley, Calif.-based Center for Genetics and Society, both oppose the use of cloning for human reproduction, but support cloning for the purpose of creating embryonic stem cells to be used in research.

The Washington-based Family Research Council, a conservative think tank and lobbying group, opposes all cloning regardless of its purpose. A bill to that effect has been proposed by the current House, but not the Senate, said David Prentice, senior fellow for life sciences at the Family Research Council.

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Stem cell research fuels more debate on cloning

Scientists use cloning to make stem cells matched to two …

By Stell Cell Research

The therapeutic cloning of an adult cell. Photo: Advanced Cell Technology

Scientists have replicated one of the most significant accomplishments in stem cell research by creating human embryos that were clones of two men.

The lab-engineered embryos were harvested within days and used to create lines of infinitely reproducing embryonic stem cells, which are capable of growing into any type of human tissue.

The work, reported in the journal Cell Stem Cell, comes 11 months after researchers in Oregon said they had produced the world's first human embryo clones and used them to make stem cells. Their study, published in Cell, aroused scepticism after critics pointed out multiple errors and duplicated images.

In addition, the entire effort to clone human embryos and then dismantle them in the name of science troubles some people on moral grounds.

The scientists in Oregon and the authors of the new report acknowledged that the clones they created could develop into babies if implanted in surrogate wombs. But like others in the field, they have said reproductive cloning would be unethical and irresponsible.

The process used to create cloned embryos is called somatic cell nuclear transfer, or SCNT. It involves removing the nucleus from an egg cell and replacing it with a nucleus from a cell of the person to be cloned. The same method was used to create Dolly the sheep in 1996, along with numerous animals from other species.

Human cloning was a particular challenge, in part because scientists had trouble getting enough donor eggs to carry out their experiments. Some scientists said SCNT in humans would be impossible.

Dr Robert Lanza, the chief scientific officer for Advanced Cell Technology, has been working on SCNT off and on for about 15 years. He and his colleagues finally achieved success with a modified version of the recipe used by the Oregon team and skin cells donated by two men who were 35 and 75.

After swapping out the nucleus in the egg cell, both groups used caffeine to delay the onset of cell division a technique that has been called "theStarbuckseffect". But instead of waiting 30 minutes to prompt cell division, as was done in the Oregon experiment, Lanza and his team waited two hours.

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Scientists use cloning to make stem cells matched to two ...

Stem cells in circulating blood affect cardiovascular …

By Stell Cell Research

PUBLIC RELEASE DATE:

23-Apr-2014

Contact: Nicanor Moldovan Moldovan.6@osu.edu 614-247-7801 Ohio State University

COLUMBUS, Ohio New research suggests that attempts to isolate an elusive adult stem cell from blood to understand and potentially improve cardiovascular health a task considered possible but very difficult might not be necessary.

Instead, scientists have found that multiple types of cells with primitive characteristics circulating in the blood appear to provide the same benefits expected from a stem cell, including the endothelial progenitor cell that is the subject of hot pursuit.

"There are people who still dream that the prototypical progenitors for several components of the cardiovascular tree will be found and isolated. I decided to focus the analysis on the whole nonpurified cell population the blood as it is," said Nicanor Moldovan, senior author of the study and a research associate professor of cardiovascular medicine at The Ohio State University.

"Our method determines the contributions of all blood cells that serve the same function that an endothelial progenitor cell is supposed to. We can detect the presence of those cells and their signatures in a clinical sample without the need to isolate them."

The study is published in the journal PLOS ONE.

Stem cells, including the still poorly understood endothelial progenitor cells, are sought-after because they have the potential to transform into many kinds of cells, suggesting that they could be used to replace damaged or missing cells as a treatment for multiple diseases.

By looking at gene activity patterns in blood, Moldovan and colleagues concluded that many cell types circulating throughout the body may protect and repair blood vessels a key to keeping the heart healthy.

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Stem cells in circulating blood affect cardiovascular ...

PARKINSONS ASSOCIATION HIRES STEM CELL SCIENTIST

By Stem Cell Medical Center

The Parkinsons Association has hired its inaugural scientist, a step the San Diego-based patient advocacy group describes as its first toward becoming a research center.

The scientist, Andrs Bratt-Leal, helps lead a project called Summit4StemCell.org, which aims to treat eight local Parkinsons patients with new brain cells grown from their own skin. The patients are raising money for their treatment. Theyre assisted by the nonprofit association and partners Scripps Health and The Scripps Research Institute.

If all goes well, treatment will start early next year.

Bratt-Leal continues to work in the lab of stem cell expert Jeanne Loring, head of the Center for Regenerative Medicine at The Scripps Research Institute. The medical arm of the project is being directed by Dr. Melissa Houser, a Scripps Health neurologist.

Bratt-Leal, as it turns out, has been working on a project of his own: Hes an expectant father. Bratt-Leal had considered leaving his job in Lorings lab to seek work closer to home in San Clemente.

Jeanne asked me to see if we could negotiate a contract with him where he would be able to stay in a broader capacity, said Jerry Henberger, the associations executive director. He didnt have the ability through The Scripps Research Institute to take that next step.

The association found the money to hire Bratt-Leal, who started as its senior scientist in February. As part of the deal, he continues to work under Lorings direction.

Raising money has been a constant concern since Summit4StemCell was founded in 2011. If a clinical trial of the therapy is approved, millions will be needed to pay for the treatment and kept as a reserve for care if the therapy goes awry.

The good news is that funding may be available from the states stem cell agency, the California Institute for Regenerative Medicine, Henberger said. The group plans to submit a proposal when the next funding round begins.

In addition, the project may qualify for financial backing from the Sanford Stem Cell Clinical Center, which was established in November with a $100 million gift from philanthropist T. Denny Sanford. The center integrates operations at UC San Diego and other La Jolla research centers to turn the science into therapies.

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PARKINSONS ASSOCIATION HIRES STEM CELL SCIENTIST

Irish cell therapy firm in E6m research

By Uncategorized

Tuesday, April 22 11:57:06

Orbsen Therapeutics, a spin-out from NUI Galway's Regenerative Medicine Institute (REMEDI), is to partner with the University of Birmingham in a E6 million EU FP7 funded MERLIN project to fight liver disease.

The EU FP7-funded project known by the acronym "MERLIN" (MEsynchymal stem cells to Reduce Liver INflammation) is led by Professor Phil Newsome, Clinical Director of the Birmingham University Stem Cell Centre. MERLIN will advance Orbsen's proprietary cell therapy to a Phase 2a clinical trial in patients with inflammatory liver disease. This MERLIN project will evaluate the Orbsen cell therapy in 4 different research laboratories across Europe and the project will culminate in a Phase 2a clinical trial of the therapy in the crippling inflammatory liver disease, Primary Sclerosing Cholangitis.

This is Orbsen's fourth success in attracting FP7 funding (the EU's Seventh Framework Programme for Research), making them one of Ireland's most successful private companies in this funding programme and now connects Orbsen to 23 global collaborators. Other successful cell therapy projects for Orbsen include PURSTEM (completed), REDDSTAR (ongoing) and DeCIDE (ongoing).

Orbsen Therapeutics Ltd. is a privately-held company founded in 2006 as a spin-out from Ireland's Regenerative Medicine Institute (REMEDI) in NUI Galway. As part of the PurStem EU FP7 program, Orbsen developed proprietary technologies that enable the prospective purification of highly defined and therapeutic (stromal) cells from several human tissues, including bone marrow, adipose tissue and umbilical cord.

Orbsen's CEO Brian Molloy said, "Orbsen has secured substantial amounts of research funding in the last 18 months which will further validate our product and bring us through to a "first in man" clinical trial in 2015/16. Our model has always focused on putting the 'science first' and we have successfully used that approach to develop a technology that could potentially position us and indeed Ireland at the leading edge of European Cell Therapy development."

Mr Molloy continued, "As a spin-out from the NUI Galway based REMEDI Institute we have focused the majority of our collaborations with an Irish research team. Our success in the MERLIN project now demonstrates that we are capable of playing a key role in collaborations led by researchers across Europe."

The total research budget for the MERLIN project is close to E6 Million of which E1 Million will go directly to Orbsen Therapeutics over the 4-year period of the project.

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Irish cell therapy firm in E6m research

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