|Dr. Camillo Ricordi|
The Diabetes Research Institute (DRI) has had positive results in the first patient in a Phase I/II, pilot trial of a technique it expects could result in a bioengineered mini organ. This could mean a breakthrough in the race to develop an artificial pancreas that produces insulin in Type 1 diabetic patients.
In the study, researchers created a biodegradable scaffold from a combination of the patient's own blood plasma and thrombin, a commonly used clinical-grade enzyme. This was used to create a gel-like substance to stick to the omentum and hold islet cells, which usually reside in the pancreas and produce hormones including insulin to regulate blood glucose. The omentum is a highly vascularized tissue that covers the abdominal organs.
"This was the first transplant of islets on the surface of the omentum using a biologic, fully re-absorbable scaffold technique. The site is easily accessed by minimally invasive surgery, and more importantly, has the same blood supply and drainage characteristics of the pancreas--where islets are originally found before they are destroyed in Type 1 diabetes," Dr. Camillo Ricordi, director of the DRI and the Stacy Joy Goodman Professor of Surgery, Distinguished Professor of Medicine, Professor of Biomedical Engineering, Microbiology and Immunology at the University of Miami Miller School.
He added, "This is the first tissue engineered islet transplant using a 'biodegradable scaffold' implanted on the surface of the omentum, to minimize the inflammatory reaction that is normally observed when islets are implanted in the liver or in other sites with immediate contact to the blood"
After this initial, ongoing pilot trial, researchers expect to move into small-group clinical studies with this islet transportation technique. Over time, the body is expected to absorb the gel, but leave the functioning islet cells intact with new blood vessels forming to support their survival. The pilot trial is also incorporating a standard immunosuppressive regimen for the islet transplantation.
"We have to show initially that this transplant can function and be equivalent to the liver as a site of implantation," said Ricordi. "We will then add all the other components that will favor new blood vessel development, oxygen generation, cell protection and other agents that will allow us to reduce and eventually eliminate systemic immunosuppression, which is our ultimate goal for a biological cure."
Research related to the project is backed by the Diabetes Research Institute Foundation, the Juvenile Diabetes Research Foundation (JDRF), The Leona M. and Harry B. Helmsley Charitable Trust, National Institutes of Health (NIH), NIH Small Business Innovation Research (SBIR), University of Miami, as well as undisclosed pharmaceutical companies, corporate and philanthropic partners.
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