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Stem Cells Free Diabetics From Insulin Shots in Study (Update1)
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By Marilyn Chase
April 14 (Bloomberg) -- Young adults newly diagnosed with type 1 diabetes avoided insulin shots for an average of 31 months when they got infusions of stem cells from their own blood, researchers said.
The study, reported today in the Journal of the American Medical Association, found that 20 of 23 patients treated with their own stem cells reduced or ended dependence on insulin as their bodies took over production of the hormone. Twelve patients stayed off insulin for extended periods, while eight relapsed and returned to low-dose shots. Three didn’t respond.
The research is part of a broad-based push to cure diabetes, which can cause cardiovascular disease, blindness, kidney failure and nerve damage. Scientists said the next step is to compare stem-cell transplants with intensive insulin injection therapy in a clinical trial, research that must get authority to proceed from the U.S. Food and Drug Administration.
“I started work on stem cells for autoimmune disease 20 years ago,” Richard Burt, co-author of the study and chief of the division of immunotherapy at Northwestern University’s Feinberg School of Medicine in Chicago, said in a telephone interview. “We work 24/7, and we’re getting there as fast as we can. It’s now in the hands of the FDA.”
Overactive Immune System
The treatment, which eliminates the risk of rejection, first damps down the patient’s overactive immune system using a chemotherapy drug. Then stem cells extracted from the patient’s own blood are treated and later returned through intravenous injection. The procedure was done within six weeks of initial diagnosis and is believed to work best in early cases before the disease has had time to inflict damage on the body.
The stem-cell technique “remains the only treatment capable of reversing type 1 diabetes mellitus in humans,” wrote the paper’s senior author, Julio Voltarelli, and colleagues at the University of Sao Paulo, Brazil, and in the U.S.
Proof that the treatment worked came from measuring patients’ levels of C peptide because that substance reflects activity in the body’s cells critical to making insulin, Burt said. The study found that C peptide increased in most patients over time, and normalized at three years.
About 23.6 million people in the U.S. have diabetes, says the American Diabetes Association. From 5 percent to 10 percent have type 1, a condition in which the body’s immune system attacks pancreatic cells that produce insulin, the hormone that enables the body to use sugar for energy. Most diabetics have type 2, an illness linked to obesity and resistance to insulin.
Cure Needed
“A cure is needed, but it will probably not come from a single breakthrough,” wrote Christopher D. Saudek of Johns Hopkins University in Baltimore, in an accompanying editorial. “More likely, the cure will be a gradual process, building over years. Biological approaches will improve incrementally, with the procedures becoming more effective with fewer adverse effects.”
Complications of the stem-cell treatment included pneumonia in two patients, low sperm counts in nine of the 17 men in the study, and endocrine dysfunction in three patients, the researchers reported.
The study released today is an extension of an earlier experiment in 2007, which reported on 15 patients who first received chemotherapy, followed by injection of their own blood stem cells. They were followed for almost 19 months, a period in which most were able to stop insulin injections.
In the current study, researchers added five patients to the original group, enlarging it to 23 volunteers who were 13 to 31 years old. They were observed for a longer period and underwent C-peptide tests to monitor their bodies’ own insulin production.
Jay Skyler, professor of medicine and associate director of the Diabetes Research Institute at the University of Miami said what’s needed now is a broader study with a control group and longer follow-up period.
To contact the reporter on this story: Marilyn Chase in San Francisco at mchase6@bloomberg.net
<i>Last Updated: April 14, 2009 14:26 EDT</i></p>