(Rough translation by Leslie Cidale of the article by GABRIELA CUPANI which appeared in the FOLHA DE SAO PAULO on April 15, 2009. The FOLHA is the largest newspaper in Brazil.)
A Brazilian study showed that the pancreas of patients with type 1 diabetes is returning to work after infusion of the patients own stem cells, freeing them of the need for insulin.
The results of the research, which has followed 23 volunteers for more than four years, are published in today's edition of the Journal of the American Medical Association.
The authors found, for the first time ever, that the levels of C-peptide, a kind of marker of the functioning of insulin producing cells, increased in patients undergoing the therapy.
C-Peptide is a waste product of the production of insulin by the beta cells of the pancreas. Higher rates of C-peptides indicate more insulin production, and therefore lower risk of complications associated with diabetes such as blindness, heart disease and peripheral arterial disease, which too often leads to amputation.
"C-peptide levels in the study participants not only stopped falling, but rose," celebrates the endocrinologist Carlos Eduardo Barra Couri, of the University of Sao Paulo in Ribeirão Preto, one of the authors of the study. "This means that the pancreas is back to work," he explains. "These patients produce more insulin than when they came to us."
The study participants have on average been off injected insulin for more than three years with good blood glucose control. "We have patients who have been off insulin for four years and eight months with excellent quality of life and no peaks of hypoglycemia," said Couri.
Eight of the twenty-three patients are back on very low doses of synthetic insulin, so there is not enough data to say that the benefits are permanent, according to immunologist Julio Voltarelli, one of the leaders of the study.
But even in these patients C-peptide levels are increased, showing that their pancreases are working better, even if not producing all of the hormone they need.
Type 1 diabetes is an autoimmune disease in which the defense system of the body starts to attack the pancreas. Therapy with stem cells seems to combat this immune failure, but does not recover the destroyed areas of the gland, hence the need to apply it in only those newly diagnosed with type 1 diabetes.
A novel effect of the drug sitagliptin was also noted as a result of the study. The drug, usually prescribed for patients with type 2 diabetes, was given to two of the patients who needed insulin again. After two months of the medication, they were once again free of the synthetic hormone. Today these patients control blood glucose levels by taking sitagliptin, which stimulates the secretion of insulin by the body, once a day.
In 2007, with the publication of the first data from stem cell transplantation, the work received harsh criticism from the international scientific community, which credited the results to a phenomena known as “the honeymoon period”, in which changes in diet and exercise, combined with the medical monitoring, would be responsible for the benefits.
"Today there is no doubt that our results are not due to the honeymoon period," Couri said, recalling that while the first article on the research published in the Journal of the AMA took a year to be accepted, the acceptance of the latter took only two months. “We don’t have the cure yet, but perhaps we are headed in the right direction,” says Voltarelli.
The University of Sao Paulo at Ribeirão Preto is still recruiting volunteers and testing less aggressive and cheaper methods of correcting flaws in the immune system. Now they are testing other lines of research in an attempt to turn off the patient’s immune system without using chemotherapy, making use of the so-called mesenchymal stem cells, already present in the body.
Study participants must be between 12 and 35 years and diagnosed with type 1 diabetes within the last six weeks. Candidates may write to firstname.lastname@example.org.