The study appearing in today's issue of the Journal of the American Medical Association involved just 15 patients. However it is an exciting advance as regards stem cell therapy directed at type 1 diabetes in particular.

Patients with Type 1 diabetes have little or no insulin-producing beta cells in the pancreas because the patient's own immune system destroys them completely. With no insulin to speak of the body cannot convert sugar into simpler products leading to diabetes. Such patients are also at a risk of developing cardiovascular disease, kidney failure and blindness.

When a patient is diagnosed with type 1 diabetes or juvenile onset diabetes, the only recourse is to start off insulin therapy. The blood sugar levels are monitored every few hours and sometimes patients require as many as five injections a day to control rising blood sugar levels.

Another avenue in treating type 1 diabetes is preservation of the existing beta cells in the pancreas by transplanting islet cells into patients. Researchers at the University of Alberta in Edmonton, Canada first reported successful islet transplantation in the June 2000 issue of the New England Journal of Medicine.

In a five-year follow up in 2005 they refined their method called the Edmonton protocol to transplant pancreatic islets into selected patients with type 1 diabetes. They reported results for 65 patients who received transplants at their center. Some 10 percent of the patients remained free of the need for insulin injections at 5-year follow-up. However many patients had to revert to insulin because the transplanted islets quickly lost their ability to produce insulin.

But type 1 diabetes patients were able to decrease their need for insulin, achieve better glucose stability, and reduce problems with hypoglycemia through this procedure.

Now a new procedure has used stem cell transplantation to produce insulin-making beta cells in patients suffering from type 1 diabetes. Stem cells are the building blocks of all types of cells in the body and have the potential to develop into any cell type.

When a stem cell divides, each new cell has the potential to either remain a stem cell or become another type of cell with a more specialized function, in this case a beta cell in the pancreas.

Lead author Dr. Julio C. Voltarelli, from the Regional Blood Center in Ribeiro Preto, Brazil and his team tested the procedure in a small trial involving 15 patients.

All patients had been diagnosed with type 1 diabetes in the previous six weeks and needed insulin to control their blood sugar levels. Researchers used high-dose immune suppression and stem cell transplantation to prevent the destruction of beta cells.

They used a technique called autologous nonmyeloablative hematopoietic stem cell transplantation (AHST) where a person's own stem cells are harvested and reintroduced into the body via an intravenous injection.

In a follow-up period of 7 to 36 months, 14 patients became insulin-free. One patient was insulin independent for 35 months, four for at least 21 months and seven for at least six months. One patient remained insulin free for one month, while the other had five months without the need for injections.

The researchers report on patients went back to needing insulin injections one year after stem cell therapy. Of the side effects two were noteworthy. One patient had pneumonia, while two others had endocrine dysfunction.

"This is, to our knowledge, the first report of high-dose immunosuppression followed by autologous nonmyeloablative hematopoietic stem cell transplantation for human type 1 DM," the researchers write. "Ninety-three percent of patients achieved different periods of insulin independence and treatment-related toxicity was low, with no mortality."

However they admitted the need for further research to reinforce their findings.

Experts said the trial was conducted in Brazil and would have found it difficult to get approval in the United States owing to the strict stem cell policy here.  Dr. Mark Anderson of the University of California at San Francisco's Diabetes Center felt a drawback of the study was a lack of a control group.

He added it was difficult to gauge the success of stem cell therapy in type 1 diabetes without a group to compare the results with. Another limitation was that the mechanism through which the stem cell transplants reduced insulin dependence remains unclear.

Until these questions are answered in a satisfactory manner, insulin remains the elixir for patients with type 1 diabetes to keep their blood sugar levels in check.
 

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