The growing epidemic of diabetes in the United States is making it crucial for scientists to find new ways to treat the debilitating disease and its numerous complications. New research just published by investigators from the Diabetes Research Institute (DRI) at the University of Miami Miller School of Medicine and Stem Cell Argentina in Buenos Aires shows that a novel protocol involving stem cells and oxygen therapy yielded promising results in a pilot study. The findings were published online March 11 in Cell Transplantation - The Regenerative Medicine Journal.

In the phase 1 pilot study, 25 patients with type 2 diabetes received autologous stem cells that were infused in the blood vessels that go to the pancreas. The patients also underwent hyperbaric oxygen treatment before and after the stem cell infusions.

In type 2 diabetes, the insulin that is produced by the beta cells in the pancreas does not work properly in the body because of insulin resistance or decreased sensitivity to the action of insulin, often combined with a reduced secretion of insulin by the pancreas. In contrast, in type 1 diabetes almost all of the beta cells have been destroyed and generally no insulin is produced.

The objective of the study was to determine if using a patient's own stem cells together with oxygen therapies would aid in the recovery of the damaged beta cells.

"These preliminary results indicated that the combination of intrapancreatic delivery of autologous stem cells and peri transplant hyperbaric oxygen treatments significantly improved insulin production, glucose levels, metabolic control and dramatically reduced the requirements for exogenous insulin injections." explains Camillo Ricordi, M.D., director of the Cell Transplant Center and the Diabetes Research Institute.

Given the results of the pilot study, researchers at the DRI have recently launched an FDA-approved clinical trial to test the protocol in additional patients. Researchers will be recruiting patients between the ages of 45 and 65 who have been diagnosed with type 2 diabetes after age 40 and have had the disease for more than five but less than 15 years.

The trial participants will be randomized to either standard drug treatment for type 2 diabetes, or to undergo a series of treatments in a hyperbaric chamber at the University of Miami Hospital. During the treatment in a pressurized chamber the patient will be breathing 100 percent oxygen. Among other effects, it's believed the high oxygen levels release stem cells from the bone marrow and allow them to circulate through the entire body.

"After 10 oxygen treatments, we will do a bone marrow tap and prepare the cells for re-infusion directly into the pancreas," explains Rodolfo Alejandro, M.D., professor of medicine and director of the clinical islet cell program at the DRI. "Basically we are taking a two-pronged approach: allowing more stem cells to be released into the body through the oxygen treatments, and then infusing the stem cells directly into the pancreas."

Following the infusion, the patients will receive an additional 10 treatments in the hyperbaric chamber.

"Applying this combined approach we will determine whether the combination of hyperbaric oxygen treatment and stem cell infusion can help the pancreas to either recover or function well enough to allow patients to significantly decrease or stop their medications," said Alejandro. "This intervention could alter the disease process in type 2 diabetes, giving the pancreas a chance to recover and possibly regenerate."

"Similar trials will take place in Europe, Asia, and Latin America as part of the DRI Federation collaborative efforts (www.diabetesresearch)," adds Ricordi. "The DRI at the University of Miami Miller School of Medicine will be the only site performing this particular protocol in the United States. If the initial encouraging results are confirmed in patients with Type 2 diabetes, similar trials will be planned for patients with Type 1 diabetes.

Diabetes Research Institute

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