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Stem Cells Research

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Archive for April, 2010

Progress to advance U.S. stem-cell research has been slow but steady since President Barack Obama revoked a policy that had limited this area of scientific study for nearly eight years. This month marks the one-year anniversary of Obama’s announcement that overturned the August 2001 order by President George W. Bush that limited the amount of federal funding for stem-cell research.

Bush’s statement said federal funding could not be used for such research unless certain conditions were met: the derivation process—which starts with the destruction of an embryo—must have been initiated before Aug. 9, 2001; the stem cells must have been taken from an embryo that was created for reproductive purposes and no longer needed; and informed consent must have been obtained for the donation of an embryo that was obtained without financial inducements.

Stem cells, which are unspecialized cells that have the capability of renewing themselves through cell division—even after long periods of inactivity—can also give rise to specialized cells for tissues or organs under certain physiological or experimental conditions, according to the National Institutes of Health. Because of their regenerative abilities, these cells could create the potential for treating conditions such as diabetes and Parkinson’s and heart disease.

With his order last year, Obama opened the nation’s $29 billion budget for stem-cell research and also lifted the limitations that Children’s Hospital Boston physician scientist Leonard Zon said have “greatly hampered” the ability to conduct research in this field.

Zon said that even though money is being spent and scientists are able to do research, the process by which stem-cell lines are available under NIH funding has taken a little more time than people thought. “After the ban, there has been a little bit of lag time to get up to speed,” said Zon, director of Children’s stem-cell program.

That process began with draft guidelines for research involving human embryonic stem cells, which the NIH released in late April 2009. The NIH received 49,000 public comments from patient advocacy groups, scientists, scientific societies, medical societies, academic institutions, religious organizations and private citizens before the guidelines became effective on July 7, 2009. In early December, the agency said it had approved 13 human embryonic stem-cell lines for use in NIH-funded research.

A representative for the NIH was unavailable for an interview, but a spokesman said in an e-mail that the fiscal 2009 figure for human embryonic stem-cell research was $143 million, which includes $14 million from the American Recovery and Reinvestment Act of 2009, also known as the stimulus law. The fiscal 2010 funding amount is expected to be $137 million, including $23 million from the stimulus law.

In the last year, Zon has worked closely with colleague George Daley and a team at Children’ Hospital—which produced 11 of those 13 lines the NIH approved—to develop a new Web site that is intended to debunk some of the myths about stem-cell research and also educate patients.

“The promises of stem-cell research are real, but we also want to be accurate in what can be done and what can’t be done,” said Zon, who added that he receives a call each week from someone wanting to travel outside the United States for treatment. “There are companies in China that will inject weird things into you with a promise that they will cure diabetes,” said Zon, who acknowledged that a person with a serious disease “might be willing to try anything.”

Children’s Hospital’s new Web site, stemcellchildrenshospital.org, is scheduled to launch on April 26. Zon said the idea behind the Web site is to give people the tools to understand the research so that they can educate others. “The biggest misconception has to do with embryonic stem cells,” Zon said, adding that most people picture a fetus when they think of stem cells. “When we’re making these lines, there is no nervous system or tissue except a solid ball of cells.”

Donald Gibbons is the chief communications officer at the California Institute for Regenerative Medicine, a granting agency in Sacramento that was created after California voters took the initiative to advance stem-cell research efforts in the absence of federal funding.

In 2004, voters passed a referendum that allowed for $3 billion in bonds to fund stem-cell research for 10 years, according to Gibbons, who said the institute has awarded $1 billion of those funds to date, including $270 million that was used to build 12 stem-cell facilities.

As Gibbons explained, there was much excitement in the field when the segment learned a year ago that it had a partner in the federal government. He also said he fears that the public might not understand how many different types of stem cells there are, and how long it will take to move beyond the clinical research phase to the approval phase.

Earlier this month, the California Institute for Regenerative Medicine allocated $50 million for stem-cell therapy development. “This funding will help speed the pace of moving these potential therapies through clinical trials and, if those trials prove successful, into doctors’ offices,” the institute said in a March 11 news release.

At 396-bed Children’s Hospital, Zon said one area of stem-cell research that requires improvement is making organs from stem cells. “We’ve learned how to make the cells,” Zon said. “Now let’s learn how to make them useful.”

This story initially appeared in this week’s edition of Modern Healthcare magazine.

The news that stem cell transplants into sufferer of Type 1 diabetes have allowed patients to forego their traditional daily insulin injections has come following research that allowed volunteers to successfully go an average of two-and-a-half years free from needing to take their multiple, daily injections with which they usually manage their condition thanks to stem cell therapy. The small study that was undertaken included 23 patients that had been recently diagnosed with type 1 diabetes. Type 1 diabetes is a condition where a person’s immune system can very quickly destroy the cells that produce insulin found in the pancreas.

The stem cell transplants appear to work by effectively re-setting the immune system on order that the body will cease attacking the pancreas. According to the researchers involved in the study such a treatment can only successfully be undertaken when Type 1 diabetes is caught early in a patient, preferably within a six week window following diagnosis and before the pancreas suffers irreparable damage and before any complications set in as a result of elevated blood sugar levels.

With regards to the study itself 23 patients received stem cell treatments in order to treat new-onset cases of type 1 diabetes, making use of follow-up data from 15 patients that initially received stem cell implants in a study previously published in 2007 combined with another eight patients that joined the study all the way up until April 2008. The patients involved in the study were aged between 13 and 31 years old with an average age of just over 18. The majority of the patients were men who had suffered for a relatively short duration from the disease before it was caught (around 37 days on average) and were, in general, free of diabetic ketoacidosis – a condition that is dangerous complication linked to Type 1 diabetes.

The new study has hinted at possible new avenues for research, although it must be stressed that the treatment is still at an early stage of its development and it is not without certain risks and side effects. In fact the research director of Diabetes UK, Dr Iain Frame, has been quick to stress that “This treatment is not a cure for type 1 diabetes.”

The researchers obtained follow-up data on all of the 23 patients that were in receipt of a stem cell therapy transplant and the length of their data collation for each patient ranged from seven to fifty-eight months. Their findings showed that 20 patients, all with no previous ketoacidosis, became insulin and injection free, and of all involved a total of twelve patients stayed insulin-free for an average of thirty-one months. Eight patients, however, suffered relapses and needed to resume taking insulin at low doses.

While the results from this study indicate that further research definitely needs to be done into the process as well as highlights the fact that there will undoubtedly need to be further work done among people of different ethnicities and among women in order to further test the findings of the study it nevertheless shows promise for many Type 1 diabetes sufferers.