Spas, salons warned on stem cell therapy

By Tina G. Santos Philippine Daily Inquirer

MANILA, PhilippinesStem cell therapy at spa centers and salons? Watch out, government agents are coming.

Health Secretary Enrique Ona says no clinic or hospital in the Philippines can offer stem cell therapy without accreditation from the Department of Health (DOH).

Speaking to reporters last week, Ona noted that while many centers are advertising stem cell therapy treatment, none of them have the approval of the health department.

As of now we have not accredited any clinic or even hospital offering stem cell therapy yet, Ona said.

Admitting that the DOH doesnt have the police power to close down erring health centers, Ona said the department would coordinate with other governmental agencies like the Department of Trade and Industry (DTI) and local governments to prevent spas and salons from offering stem cell treatment.

We will issue a warning for them to stop [doing stem cell therapy]. But if they continue despite warnings from us, thats when we will move to close them down, Ona said.

Stem cell therapy and treatment, which are becoming popular here and abroad, are medical procedures that deal with ailments by replacing malignant cells with healthy cells.

Only medical doctors with the right training can perform stem cell treatment.

Cosmetic purposes

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Spas, salons warned on stem cell therapy

Italy pushes on with controversial stem cell therapy

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

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’

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

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