Stem Cell Clinic

Italy pushes on with controversial stem cell therapy

By Stem Cell Treatment

Italian health officials are allowing a handful of patients to continue with a controversial stem cell therapy amid protests from scientists that the treatments are unproven and unsafe.

The Stamina Foundation has been administering the therapy at the public hospital Spedali Civili of Brescia to people with a range of degenerative diseases. Their approach is based on mesenchymal stem cells, derived from bone marrow, which can become mature bone and connective tissue.

In 2011 the hospital agreed to host the research and assist with cell extraction and patient treatments, stirring protests from the medical community. "The hospital is not even listed among the 13 Italian authorised stem cell factories," says Michele de Luca, director and gene therapy programme coordinator at the Centre for Regenerative Medicine in Modena. After an inspection in 2012, Italian drug regulator AIFA ordered an immediate halt to Stamina's stem cell treatments at the hospital.

The AIFA report says the Stamina Foundation's treatment did not follow Italy's official path required for clinical approval. So far no scientific publications describing its effectiveness are available.

But the halt sparked protests among patients' families who believed the treatment was working. Some appealed to the courts, and as a result a few patients were allowed to go ahead with the therapy. On 15 March, a group of 13 Italian stem cell researchers published an open letter to the country's Minister of Health, Renato Balduzzi, asking him to shut down all of the Stamina Foundation's treatments at the hospital.

Instead Balduzzi signed a bill last week authorising the foundation to continue treatments in patients who had already begun the regime unless they are experiencing serious side effects.

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Italy pushes on with controversial stem cell therapy

Scientists Slam Italy’s Untested Stem Cell Therapy

By Stem Cell Treatment

ROME -- European scientists are criticizing a decision by Italy's government to allow a handful of children to be treated in public hospitals with an experimental stem cell therapy.

The adult stem cell treatment was halted in May by the Italian Pharmacological Agency. But the government last week overruled the regulator after parents went to court to demand that the therapy be continued. The health ministry, citing ethical and compassionate concerns, said the therapy shouldn't be interrupted since it hadn't shown any "grave collateral effects" in the children, some of whom are terminally ill.

In a letter to Italy's health minister, Renato Balduzzi, more than a dozen scientists criticized the decision, saying it "seems to be dictated by emotions raised by public opinion rather than scientifically based reasons."

The decision to allow the unproven therapy by the Stamina Foundation, which is based in Italy, came despite findings from a police search, including inspectors from the Italian Pharmacological Agency, at the laboratory where the stem cell treatments were being prepared.

In May, the agency ordered all work at the Stamina Foundation laboratory to stop after finding that conditions were "absolutely inadequate." The inspectors said there were "terrible maintenance and cleanliness conditions" that couldn't guarantee the cells weren't contaminated. The agency also said the doctors administering the adult stem cell treatment weren't aware of what they were injecting and the patients' medical records didn't detail the therapies.

Adult stem cells can maintain and repair tissues within a person, but there is no known benefit of removing such cells and using them to treat patients. Most research into stem cells concerns embryonic stem cells, often considered controversial because they involve the destruction of embryos. Embryonic stem cells can produce a wide variety of specialized cells, and scientists are working to harness them as repair kits for diseases, including Parkinson's and diabetes. By comparison, adult stem cells have a more limited ability to turn into other types of body tissue and are more likely to contain abnormalities than those derived from embryos. Balduzzi defended the decision to allow the treatment and described it as a "compassionate" ruling. He said it would only continue in public hospitals or research clinics under strict monitoring with the consensus of an ethics committee. The government ruling covers patients already receiving the Stamina Foundation treatment, those who had begun preparatory procedures such as the cultivation of cells, or those who by court order had been authorized to begin the treatment. "The decision of the government to authorize the continuation of therapies ordered by judges was necessary to prevent discrimination, based on autonomous decisions by judges, between patients who had begun treatment with the Stamina Method," Balduzzi said.

Several British scientists said the Italian decision set a dangerous precedent and could even encourage desperate patients to seek treatment abroad. "If politicians, doctors or patient organizations ignore the facts, they may unwittingly become party to exploitation of the most vulnerable members of society by approving meaningless `treatments,'" Austin Smith, director of the Cambridge Stem Cell Institute, said in a statement. Steve Dunnett, a stem cell expert at the University of Cardiff, said it was worrying that no details on the experimental procedure or its results in patients had been published. "Our starting position has to be that the marketing is a scam to which the correct response should indeed be to refuse a license and certainly not pay for a spurious treatment out of the public purse," Dunnett said in a separate statement.

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Scientists Slam Italy's Untested Stem Cell Therapy

Stem cell fate depends on ‘grip’

By Stem Cell Treatment

Mar. 28, 2013 The field of regenerative medicine holds great promise, propelled by greater understanding of how stem cells differentiate themselves into many of the body's different cell types. But clinical applications in the field have been slow to materialize, partially owing to difficulties in replicating the conditions these cells naturally experience.

A team of researchers from the University of Pennsylvania has generated new insight on how a stem cell's environment influences what type of cell a stem cell will become. They have shown that whether human mesenchymal stem cells turn into fat or bone cells depends partially on how well they can "grip" the material they are growing in.

The research was conducted by graduate student Sudhir Khetan and associate professor Jason Burdick, along with professor Christopher Chen, all of the School of Engineering and Applied Science's Department of Bioengineering. Others involved in the study include Murat Guvendiren, Wesley Legant and Daniel Cohen.

Their study was published in the journal Nature Materials.

Much research has been done on how stem cells grow on two-dimensional substrates, but comparatively little work has been done in three dimensions. Three-dimensional environments, or matrices, for stems cells have mostly been treated as simple scaffolding, rather than as a signal that influences the cells' development.

Burdick and his colleagues were interested in how these three-dimensional matrices impact mechanotransduction, which is how the cell takes information about its physical environment and translates that to chemical signaling.

"We're trying to understand how material signals can dictate stem cell response," Burdick said. "Rather than considering the material as an inert structure, it's really guiding stem cell fate and differentiation -- what kind of cells they will turn into."

The mesenchymal stem cells the researchers studied are found in bone marrow and can develop into several cell types: osteoblasts, which are found in bone; chondrocytes, which are found in cartilage; and adipocytes, which are found in fat.

The researchers cultured them in water-swollen polymer networks known as hydrogels, which share some similarities with the environments stem cells naturally grow in. These materials are generally soft and flexible -- contact lenses, for example, are a type of hydrogel -- but can vary in density and stiffness depending on the type and quantity of the bonds between the polymers. In this case, the researchers used covalently cross-linked gels, which contain irreversible chemical bonds.

When seeded on top of two-dimensional covalently cross-linked gels, mesenchymal stem cells spread and pulled on the material differently depending on how stiff it was. Critically, the mechanics guide cell fate, or the type of cells they differentiate it into. A softer environment would produce more fat-like cells and a stiffer environment, where the cells can pull on the gel harder, would produce more bone-like cells.

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Stem cell fate depends on 'grip'

Scientists criticize Italy for allowing unproven stem cell therapy

By Stem Cell Treatment

Scientists have criticized an Italian government decree allowing a group of terminally-ill patients to continue using an unproven stem cell treatment, saying such therapies may cause harm and risk exploiting desperate people.

The treatment, created by the privately-owned Stamina Foundation, was banned by Italian medicines regulator AIFA last year after it inspected their laboratories, leading to a series of legal challenges by families of patients.

In early March, Health Minister Renato Balduzzi allowed a terminally ill child to continue using the Stamina treatment after hearing the emotional pleas of her parents.

Related: Catholic Church gives its blessing to stem cell research in new book

The Health Ministry then issued an official decree on March 21 allowing 32 patients, mainly children, already using the treatment to continue it.

Scientists from around Europe released a statement on Thursday criticizing the decree, warning that Balduzzi was "riding roughshod over existing European licensing criteria", failing to protect patients from exploitation and ignoring the need for sound evidence that therapies are effective.

"These unproven and ill-prepared stem cell therapies, for which there is no scientific basis, will do nothing for patients and their families except make them poorer," said Charles French-Constant from the University of Edinburgh's Center for Regenerative Medicine.

'Dangerous precedent'

Advocates of the therapy say strict regulations work in favor of big drug companies with their portfolio of blockbuster treatments, reducing the pool of potential competitors. But scientists said Stamina's treatment was unproven and risky.

"There is no rationale for this and no evidence that these procedures are not dangerous for patients," said Professor Michele De Luca of the University of Modena.

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Scientists criticize Italy for allowing unproven stem cell therapy

IDIBELL signs agreement with Histocell to use … – Stem Cell Cafe

By Stell Cell Research

Mar 28

The Bellvitge Biomedical Research Institute (IDIBELL) has signed a licensing agreement with the Spanish biotech company Histocell to make use of a patent for the treatment of acute pulmonary diseases with mesenchymal stem cells. These cells, administered intravenously, have the ability to go directly to the damaged lungs, acting as a &smart drug&.

To enhance the effect, researchers have modified this cells by genetic engineering. The studies have been developed by a team led by Josep Maria Aran, researcher at the Human Molecular Genetics group of IDIBELL, in collaboration with researchers of the Pneumology group at Vall d&Hebron Research Institute (VHIR) and the Biomedical Research Network Centre for Respiratory Diseases (CIBERES). The outcomes of the research have supposed an international patent application managed by the Technology Transfer Office (TTO) at IDIBELL.

The researchers use adult mesenchymal stem cells extracted from adipose tissue obtained from liposuction. These cells are capable of enhancing the regeneration of the damaged lung tissue and secrete inflammatory proteins therein when injected into the blood.

Improvements

The novelty patented by IDIBELL and VHIR researchers has been the insertion of improvements through genetic engineering that can significantly enhance the anti-inflammatory and regenerative power of the mesenchymal cells. Specifically, researchers have modified the antagonist to secrete interleukin 33, a regulatory protein (cytokine) that has a fundamental role in the inflammatory process.

The treatment has proven to be very effective given intravenously, although it could be considered the option of administering it by inhalation.

In the administered dose, these stem cells do not involve immune rejection, because the body removes them after their function is performed. This makes them particularly useful for treating acute diseases.

Good results

Read the original post: IDIBELL signs agreement with Histocell to use patent for acute pulmonary diseases with stem cells

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IDIBELL signs agreement with Histocell to use ... - Stem Cell Cafe

Lifespan opens stem cell research lab in Knowledge District

By Stem Cell Treatment

PROVIDENCE Lifespan opened a new stem cell research laboratory Wednesday afternoon on the fifth floor of the hospital networks Coro Building. The lab is the first phase of a major investment to turn the entire building in Providences Knowledge District into a state-of-the art research facility.

Construction of the new 11,000-sqare-foot research lab, a Center for Biomedical Research Excellence for Stem Cell Biology, was funded through a $300,000 National Institutes of Health grant to Dr. Peter Quesenberry, director of hematology oncology at Rhode Island and The Miriam hospitals.

The lab will provide researchers with the state-of-the-art technology needed to support ongoing research in the areas of cancer, tissue injury and basic stem cell biology, according to Quesenberry.

This new lab space will help us to further study the use of stem cells for the treatment of many illnesses various forms of cancer, tissue and organ damage and much more, Quesenberry said. Creating this research hub provides our researchers with the best possible resources, and places us in close proximity to the hospitals, allowing us to more appropriately collaborate with our peers, and truly bring research from the bench to the bedside.

The laboratory also will support research in novel anti-cancer treatments for pediatric and adult malignancies, and will continue to examine therapeutic mechanisms underlying refractory leukemia and lymphoma, according to hospital officials. The new lab space can accommodate 14 laboratory benches, and can accommodate 10 funded investigators, as well as their technicians and students.

Part of Rhode Island Hospitals mission is to be at the forefront of patient care by creating, applying and sharing the most advanced knowledge in health care, said Peter Snyder, senior vice president and chief of research at Lifespan. One of the ways we do that is by providing our researchers with the tools they need to conduct cutting-edge research in order to discover and create improved diagnostic measures and treatments.

This new research space is the first step in a major renovation project of the 270,000-square-foot Coro Building, creating a research facility that will serve as a focal point for clinical research in Rhode Island, according to Snyder.

Notable elected officials speaking at the labs opening and tour included Gov. Lincoln D. Chafee, Lt. Gov. Elizabeth H. Roberts, U.S. Sens. Jack Reed and Sheldon Whitehouse, U.S. Rep. James R. Langevin, and Providence Mayor Angel Taveras.

Speakers from the Rhode Island medical community included Dr. Edward Wing, dean of medicine and biological sciences at The Warren Alpert Medical School at Brown University, Dr. Timothy J. Babineau, president and CEO of Lifespan, Snyder, Quesenberry, and Dr. Louis Rice, chief of the department of medicine at Rhode Island and The Miriam hospitals.

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Lifespan opens stem cell research lab in Knowledge District

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