Category Archives: Cell Therapy

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Misconduct update Haruko Obokata, a stem-cell researcher at the RIKEN Center for Developmental Biology in Kobe, Japan, has agreed to retract one of her two controversial research papers, according to media reports in Japan on 28May. In the papers published in Nature in January, Obokata claimed that she had created a new type of stem cell using simple exposure to acid or physical stress. But the work was found to have included manipulated and duplicated images, and in April a RIKEN investigation found Obokata guilty of misconduct. See go.nature.com/wsfox5 for more.

Weight issues Obesity is on the rise throughout the world, researchers announced on 28May. Data from more than 19,000 individuals in 188 countries show that the prevalence of overweight and obese people rose by 27.5% for adults and by 47.1% for children between 1980 and 2013. Almost two-thirds of obese people live in developing countries. The study found no countries in which obesity rates had fallen significantly (M. Ng et al. Lancet http://doi.org/szv; 2014).

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Cleaner power in prospect Existing US power plants will have to cut their carbon dioxide emissions by 30% below 2005 levels by 2030 under a plan from the Environmental Protection Agency (EPA) released on 2 June. The proposal will help to steer the United States towards reducing total greenhouse-gas emissions by 17% below 2005 levels by 2020, to meet a 2009 pledge from President Barack Obama. Power plants (such as the Bruce Mansfield Plant in Pennsylvania, pictured) are the single largest source of carbon pollution in the country. Regulations exist to limit emissions of pollutants such as arsenic and mercury, but there are no national controls on carbon-emission levels. The EPA expects to finalize the plan by June 2015, after a 120-day period for public comment. See go.nature.com/gjyruv for more.

IQ on trial Some defendants with intelligence-quotient (IQ) scores of more than 70 may now escape execution on the basis of intellectual disability, after a US Supreme Court ruling on 27May. The ruling came in favour of Freddie Lee Hall, a convicted murderer in Florida who has spent 35years on death row. Federal law prohibits the execution of intellectually disabled people, defined under Florida law as an IQ of less than 70. In his latest test, Hall had an IQ of 71. The Supreme Court affirmed the position of psychiatrists that IQ tests have a ten-point margin of error. The case now returns to Floridas court for a reassessment. See go.nature.com/xiiitc for more.

EU clinical trials New rules governing clinical trials across Europe became law on 27May when they were published in the Official Journal of the European Union. The rules were overhauled to simplify how trials are approved, including harmonizing application procedures across all 28member states, and include an obligation to disclose research results. They will come into force in mid-2016.

Patent clarity The US Supreme Court moved to rein in ambiguous patents in a ruling on 2June. The decision relates to a case concerning a patent on heart-rate monitors used during exercise. A lower court had ruled that the patent was valid despite being somewhat ambiguous. The Supreme Court said that the lower court should have higher standards for patent clarity. The move could have implications for patent trolls, who take advantage of ambiguous patents to sue companies for infringement. See page 7 for more.

Rights to therapy Patients do not have an automatic right to try a compassionate therapy when there is no scientific evidence that it works, according to a landmark ruling of the European Court of Human Rights in Strasbourg, France. The 28May ruling referred to the case of Nivio Durisotto, who wanted his daughter, who has a degenerative brain disease, to be treated with a controversial stem-cell therapy offered by the Stamina Foundation in Brescia, Italy. Staminas president Davide Vannoni who is facing charges of fraud had encouraged patients to appeal for the right to treatment on compassionate grounds. See go.nature.com/xqdpfb for more.

GM compromise The European Union (EU) reached a compromise on the cultivation of genetically modified (GM) crops, in a closed-door meeting on 28May. EU member states are currently supposed to allow cultivation of any GM crop that the European Food Safety Authority deems safe for health and the environment. But some countries have refused, creating a constitutional stand-off. Now, EU member states will be allowed to opt out of growing GM crops on non-scientific grounds, such as issues relating to town and country planning. European environment ministers will vote on the proposal on 12June; it also requires parliamentary approval.

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Seven days: 30 May5 June 2014

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Embryonic stem cells may have the ability to repair damaged tissue.

A landmark stem-cell trial is sputtering back to life two-and-a-half years after it was abandoned by the California company that started it. But it now faces a fresh set of challenges, including a field that is packed with competitors.

The trial aims to test whether cells derived from human embryonic stem cells can help nerves to regrow in cases of spinal-cord injury. It was stopped abruptly in 2011 by Geron of Menlo Park, California (see Nature 479, 459; 2011); the firm said at the time that it wanted to focus on several promising cancer treatments instead. Now, a new company Asterias Biotherapeutics, also of Menlo Park plans to resurrect the trial with a US$14.3-million grant that it received on 29May from the California Institute for Regenerative Medicine (CIRM), the states stem-cell-funding agency.

But the field has moved on since Geron treated its first patient in 2010, and the therapy that Asterias inherited is no longer the only possibility for spinal-cord injury. StemCells, a biotechnology company in Newark, California, has treated 12 patients in a safety study of a different type of stem cell, and it plans to start a more advanced trial this year to test effectiveness. And another entrant to the field, Neuralstem of Germantown, Maryland, received regulatory approval in January 2013 to begin human tests of its stem-cell product.

Gerons human trial was the first approved to use cells derived from human embryonic stem cells. But regulators halted it twice, once citing concerns about the purity and predictability of the cells being implanted, and again after the company reported seeing microscopic cysts in the spinal cords of rats that had been treated in preclinical studies. The worry was that the cysts could be teratomas uncontrolled growths that can form from embryonic stem cells, a feared side effect of treatment. Geron later said that the growths were not teratomas, and the US Food and Drug Administration allowed the trial to proceed. But after injecting the cells into five of the ten intended patients, the company said that it had run out of money for the trial.

Geron founder Michael West and former chief executive Thomas Okarma then formed Asterias, which bought Gerons stem-cell therapy last year. The company plans first to treat three patients with spinal-cord damage in the neck, using a low dose of the stem cells; it will then treat different people with higher doses to see if the therapy can restore any sensation or function in the trunk or limbs.

The five patients previously treated by Geron, whom Asterias continues to track, had cord damage at chest level. On 22May, Asterias reported that none of those five had experienced serious side effects from the treatment or developed immune responses to it.

Researchers say that the continuation of the former Geron trial is important because it uses a type of cell different from the fetus-derived ones used by StemCells and Neuralstem. Geron surgically implanted embryonic stem cells that had been coaxed in vitro to grow into immature myelinated glial cells, which insulate nerve fibres when mature. The other companies are using partially differentiated cells derived from fetal brain tissue, which might produce substances that protect surviving tissue and make new connections in the neural circuitry.

Its very good for the field, because we now have multiple cell lines being tested in very similar populations of patients, and this will help us define what is needed to make this approach work, says Martin Marsala, a neuroscientist at the University of California, San Diego, whose work has shown that Neuralstems cells can develop into working neurons and restore movement to rats with cord injuries in the neck.

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Funding windfall rescues abandoned stem-cell trial

Nearly 1,650 people in the U.S. are awaiting lung transplants. Unfortunately, both domestically and abroad, the demand for donor lungs far outpaces the supply. The limited availability of donor lungs can lead to long delays before transplant, leaving patients to face a mortality rate of up to 40 percent while they wait.

Most potentially transplantable lungs are rejected by surgical teams because of injury or dysfunction, such as pulmonary edema (fluid build-up in the lungs). In addition to rendering lungs unusable for transplant, pulmonary edema also signals that the lungs are not functioning properly post-transplant and is a major cause of illness and death among lung transplant recipients. Lungs that can clear fluid better are associated with better outcomes among recipients after transplantation.

In this study, Danny F. McAuley, Gerard F. Curley, Umar I. Hamid, John G. Laffey, Jason Abbott, David H. McKenna, Xiaohui Fang, Michael A. Matthay, and Jae W. Lee looked at whether lungs that were rejected for transplantation because of edema could be "reconditioned" to qualify for transplant. They studied donor lungs that had been rejected for transplantation by the Northern California Transplant Donor Network and that were cleared for research use by the donors' families.

Roughly 50 percent of these rejected lungs had a decreased capacity to reabsorb lung fluid. The research team found that administering human mesenchymal stem (stromal) cells (MSCs) intravenously restored the ability of the lung to remove alveolar edema fluid more normally. The research highlights the potential for MSC administration as a therapy for resolving pulmonary edema and improving donor lungs before transplantation. The study has implications for increasing the supply of usable donor lungs available for transplant.

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The above story is based on materials provided by American Physiological Society (APS). Note: Materials may be edited for content and length.

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Stem cell therapy may help recondition lungs previously rejected for transplant

Patients do not have an automatic right to a compassionate therapy for which there is no scientific evidence of efficacy, according to a landmark ruling of the European Court of Human Rights in Strasbourg.

The 28 May ruling referred to the case of Nivio Durisotto, whose daughter suffers a degenerative brain disease. He wished her to be treated with a controversial stem cell-based therapy offered by the Stamina Foundation, based in Brescia, Italy.

But more generally, it will guide any judge facing requests from desperate patients for access to unproved therapies promoted from outside the regulated medical sector.

The judgement is yet another blow for the Stamina Foundation, whose president, Davide Vannoni, is now facing charges of fraudulently obtaining public money to support his therapy.

The Italian Medicines Agency had closed down the Stamina operations in August 2012 on safety grounds (see Leaked files slam stem-cell therapy). In March 2013, the government issued a decree allowing patients to continue Stamina treatment if they had already begun.

Then on 11 September, 2013 an expert committee appointed by the health ministry to examine the Stamina method concluded that there was no evidence to indicate that it might be efficacious (see Advisers declare Italian stem-cell therapy unscientific). The committee further warned that it could be dangerous.

With encouragement from Vannoni, some patients appealed to courts for the right to treatment with the Stamina method. Some judges ruled that the treatment should be given on compassionate grounds, while others including the judge in the Durisotto case ruled that compassionate therapy was not justified because there was no scientific evidence of efficacy.

Durisotto brought his appeal to the European Court of Human Rights on 28 September, 2013 a month after losing his case in Italy.

The European Court dismissed Durisottos claim, saying that the Italian courts ruling had pursued the legitimate aim of protecting health and was proportionate to that aim. It further said that the Italian courts decision had been properly reasoned and was not arbitrary, and that the therapeutic value of the Stamina method had, to date, not yet been proven scientifically. Because the case had been appropriately reasoned, it said, Durisottos daughter had not been discriminated against even if some other national courts had allowed the therapy for similar medical conditions.

Munich-based patent lawyer Clara Sattler de Sousa e Brito, an expert in biomedical laws, says that this clear ruling that scientific proof is necessary will help avoid the use of unproven therapies for so-called compassionate purposes in the future.

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Human rights court rules that evidence must support compassionate therapy

Beverly Hills, California (PRWEB) May 29, 2014

The Beverly Hills Orthopedic Institute is now providing several types of stem cell procedures for healing ligament injuries and meniscal tears of the knee. The stem cell therapies are often able to repair the injuries, provide pain relief and help patients avoid the need for surgery. For more information and scheduling, call (310) 438-5343.

Injuries to the knee may occur from sports injuries, auto accidents or result from degenerative arthritis. Conventional treatments typically work well for pain relief, however, they do not repair the damaged soft tissue. Therefore, conventional treatments result in healing that is incomplete and may still lead to the need for the surgery.

At Beverly Hills Orthopedic Institute, Double Board Certified Los Angeles Orthopedic Surgeon Dr. Raj has been a pioneer in stem cell procedures for the knee. He is an expert in several types of stem cell therapies for knee injuries including amniotic derived or bone marrow derived stem cell injections.

The regenerative medicine procedures are performed as an outpatient and maintain exceptionally low risk. The amniotic-derived stem cell material is processed at an FDA regulated lab, while the bone marrow-derived stem cell therapy involves a short harvesting procedure from the patient himself. Both types of procedures have been shown in small studies to have excellent clinical results for knee conditions.

Along with treating all types of knee injuries with stem cell therapy, Beverly Hills orthopedic surgeon Dr. Raj also treats shoulder, hip ankle and spinal conditions with regenerative medicine as well. Treatments are provided for amateur and professional athletes, weekend warriors, executives, grandparents, students and more.

For those who desire to explore stem cell procedures for helping repair knee injuries and avoiding surgery, call the Beverly Hills Orthopedic Institute at (310) 438-5343.

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Beverly Hills Orthopedic Institute Now Offering Stem Cell Procedures for Meniscal Tears and Ligament Injuries of the ...