University researchers are launching a clinical trial that may aid a widespread attempt to end insulin injections for some Type 1 diabetes patients.
The University’s Diabetes Institute for Immunology and Transplantation’s trial involves transplantations of islets, which are groups of cells that produce insulin.
If successfully transplanted, the islets release the correct amount of insulin into the body, possibly eliminating the need for insulin injections.
Similar clinical studies have been conducted before; however, the new trials aim for Food and Drug Administration-approved islet transplantation.
Dr. Bernhard Hering, the primary investigator, said FDA approval is a critical step in fighting the disease.
“Such an approval will send a very strong message and will establish islet transplantation as a therapy,” he said.
The institute has conducted four sets of similar trials since 2000, with 26 subjects receiving islet transplantation.
Of those receiving the transplants, about 90 percent became insulin independent after the trials, with a five-year retention rate of 50 percent, according to institute data.
Some past participants have been insulin-injection free for more than seven years, and that success shows undeniable positive results, Hering said.
“Those transplants have really helped patients enjoy happy and productive lives that are no longer restricted by the constant fears and worries of devasting and deadly diabetes complications,” he said.
Decades of research have led to the institute’s success in the field, which has put researchers on the cusp of a possible cure, Hering said.
Despite some success, the long-term impact of islet transplants remains unknown, and recipients must take immunosuppressive or anti-rejection drugs, according to the American Diabetes Association.
Tony Pecora, who received a transplant in 2002, said he lives with the fear of unknowns every day.
Pecora’s biggest concern revolves around the immunosuppressants he takes, because those weaken his immune system. That affects the way he thinks about even shaking some people’s hands.
Despite the concern, Pecora said life after the transplant has been easier; when he had the disease, he worried about his young children.
“It became a difficult consideration about if I lapsed or had a problem with (my kids), what would be the impact of that?” he said.
Pecora said he also feels better in general now and hopes others with diabetes will be able to turn to the treatment if it’s approved.
“This is appropriate for a large part of the diabetic population,” he said.
Between 1 million and 2 million Americans have Type 1 diabetes, according to estimates from the American Diabetes Association.
The institute is one of seven sites in the country funded by the National Institutes of Health as part of Clinical Islet Transplantation Consortium. Others include the University of Miami and Northwestern University.
Receiving funding for such research is an extensive process that includes peer review, Dr. Brian Flanagan, scientific program coordinator for the institute, said.
Funding groups like the National Institutes of Health send out requests for applications, and prospects then respond by sending a research proposal.
The fact that the institute was chosen sheds a positive light on the status of research at the University, he said.
“It says that, worldwide, we’re in the top four or five and, in the United States, probably within the top three,” Flanagan said, citing that top institutes around the world apply.
The enrollment process for the trials is under way, and the transplantation is currently only available to those who participate in the trials.