Friday, October 4, 2013

Stem cell stories that caught our eye: spit and tears, spinal cord injury and pancreas transplants falling behind in U.S.

Pancreatic islet cells. Photo by Rachel Hermosillo
 Here are some stem cell stories that caught our eye this past week. Some are groundbreaking science, others are of personal interest to us, and still others are just fun.  

Replacement glands for spit and tears. We take many things our bodies do for granted. Producing saliva and tears definitely fit that category. But if you know anyone with dry eye or dry mouth syndrome, you know how miserable people are when these basic functions go wrong. Now, a team at Tokyo University has reported growing precursors of salivary glands and tear ducts that were able to mature into functioning glands when transplanted into mice. They started with two types of adult stem cells, those for epithelial tissue and those for mesenchymal tissue. They grew them in 3-D lab conditions and created precursors to the glands before transplanting them. They published the work in Nature Communications October 1 and a reporter at The Scientist wrote about the stem cell advance.

Spinal cord injury trial expands to U.S. It is always a pleasure to report a stem cell clinical trial making advances through the various stages of testing. Stem Cells Inc. has been conducting a trial of its adult nerve stem cells in people with spinal cord injury in Switzerland for more than a year. Those early patients have shown no problems with safety, and with that data in hand the company got the go-ahead from the Food and Drug Administration to expand the trial to patients in the U.S. Yahoo Finance picked up the company’s press release on the clinical trial. CIRM funds the company to conduct the preclinical animal testing needed to get approval to use the same cells as a potential therapy for Alzheimer’s. We discuss this project on our Alzeheimer’s and stem cell fact sheet. Our governing Board voted to fund an expansion of the company’s spinal cord project last year, but the firm decided to take it forward with private funds. You can read about our related programs on our spinal cord injury fact sheet.  

US falling behind in islet transplants. The International Pancreas and Islet Transplantation Association met this past weekend down the coast in Monterey. It was an upbeat meeting in terms of the reports of progress in successfully transplanting donor pancreatic islets to reduce diabetics’ reliance on injected insulin. But the press release from the association picked up by Yahoo Finance had a definite down side regarding transplants in the U.S. It stated that because of regulatory issues and poor reimbursement by insurers, the number of islet transplants in the U.S. had fallen 30 percent since 2005. The release noted that the procedure is fully reimbursed in parts of Canada, the United Kingdom, Switzerland, Belgium, Norway, Sweden and Australia. One more area where our healthcare system is behind many developed nations. The press release also noted that the group heard some presentations on exciting new work using pancreatic cells grown from stem cells, rather than the cadaver donors that are the source of transplants today. CIRM funds work that is close to clinical trials in this area. You can read about it at our Diabetes fact sheet.

Don Gibbons

1 comment:

  1. Pharmaceutical firms paid to attend meetings of panel that advises FDA

    Patient advocacy groups said the electronic communications suggest that the regulators had become too close to the companies trying to crack into the $9 billion painkiller market in the United States. FDA officials who regulate painkillers sat on the steering committee of the panel, which met in private, and co-wrote papers with employees of pharmaceutical companies.

    The FDA has been criticized for failing to take precautions that might have averted the epidemic of addiction to prescription drugs including Oxycontin and other opioids.

    “These e-mails help explain the disastrous decisions the FDA’s analgesic division has made over the last 10 years,” said Craig Mayton, the Columbus, Ohio, attorney who made the public records request to the University of Washington. “Instead of protecting the public health, the FDA has been allowing the drug companies to pay for a seat at a small table where all the rules were written.”

    Even as the meetings were taking place, the idea of FDA officials meeting with firms that had paid big money for an invitation raised eyebrows for some. In an e-mail to organizers, an official from the National Institutes of Health worried whether the arrangements made it look as if the private meetings were a “pay to play process.”

    FDA officials did not benefit financially from their participation in the meetings, the agency said. But two later went on to work as pharmaceutical consultants and more than this, the critics said, the e-mails portray an agency that, by allowing itself to get caught up in a panel that seemed to promise influence for money, had blurred the line between the regulators and the regulated.

    At one point, an NIH staffer indicated that given the fees paid by drug companies, as well as that the meetings were private, IMMPACT could be criticized because it was “paid for by a few large pharmaceutical firms who are assumed to be influencing the outcomes.”

    http://www.washingtonpost.com/business/economy/pharmaceutical-firms-paid-to-attend-meetings-of-panel-that-advises-fda-e-mails-show/2013/10/06/a02a2548-2b80-11e3-b139-029811dbb57f_story.html

    So is it a team meeting to maximize health outcomes or maximize profit ?

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