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Pilot Clinical Trial will Test a New Site in the Body for a DRI BioHub Platform

The Diabetes Research Institute is testing the omentum as a possible location to house a DRI BioHub
The pilot clinical trial will test the omentum, an apron-like lining covering abdominal organs, as a possible site for a DRI BioHub.

The biodegradable scaffold is made using a patient's own plasma together with thrombin, a clinical-grade enzyme. When combined, they create a "sticky gel" that holds the islets in place. The area of the omentum is then folded over around the scaffold mixture.

In 2013, the Diabetes Research Institute and Foundation announced the next step in its approach to discover a biological cure by developing a DRI BioHub – a bioengineered “mini organ” that mimics the native pancreas, containing real insulin-producing cells that sense blood sugar and release the precise amount of insulin needed, in real time, together with critical components that keep the cells safe, healthy and functioning long term.

The BioHub is a platform approach that builds upon decades of progress in clinical islet transplantation and holds the promise of achieving a practical cure by restoring natural insulin production in millions of children and adults living with diabetes.

Over the last year, DRI Director Dr. Camillo Ricordi and his team have been investigating an optimal location within the body to house a BioHub. Currently, islets are transplanted into the liver, but that site is not an ideal home for the cells. One area of focus is the omentum, an apron-like lining inside the abdomen. DRI researchers believe that the omentum may be an ideal location for a BioHub.

“The omentum is a very vascularized tissue that is easily accessed surgically and, most importantly, has the same blood supply and drainage characteristics of the pancreas,” said Dr. Ricordi.

Encouraging preliminary data in experimental and pre-clinical models has shown that islets in the omentum can engraft and improve blood glucose control.

“We have observed long term-survival and function of the islets in this site,” said Dr. Dora Berman-Weinberg, a member of the DRI’s Cell Transplant Center, who conducted these experiments with Dr. Antonello Pileggi, director of Preclinical Cell Processing and Translational Models, and their respective teams. 

"We were able to establish and optimize a protocol for implanting islets onto the surface of the omentum. Preliminary islet transplantation studies in experimental models of diabetes confirmed the feasibility of this approach," said Dr. Pileggi. 

This exciting research is now moving to patient trials. The DRI has received approval from the Food and Drug Administration to proceed with a Phase I/II clinical trial that will test the omentum as a possible transplant site for a DRI BioHub. In this pilot trial, researchers will transplant insulin-producing islet cells within a “biodegradable scaffold,” one of the approaches considered for a BioHub platform.

The biodegradable scaffold is a combination of a patient's own plasma and thrombin, a commonly used, clinical-grade enzyme. When combined, these substances create a gel-like material that sticks to the omentum and holds the islets in place. This section of the omentum will be folded over and stitched, creating a pouch around the biodegradable scaffold mixture. Over time, the body will absorb the gel, leaving the islets intact, while new blood vessels are formed to support their survival and function. This pilot trial will include the immunosuppressive regimen currently used for clinical islet transplantation studies.

Watch the NEW episode of DRI tv to learn more about the DRI's Pilot Clinical Trial that will test the omentum as a possible transplant site for a BioHub.
Tune in to DRI tv for updates on the DRI BioHub and research toward a cure for diabetes.
 
 

“This is a very important first step in the overall development of the BioHub because this will set the site of implantation and the platform technology. We have to show initially that this transplant can function and be equivalent to the liver as a site of implantation,” explains Dr. 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 goal for a biological cure.”

The DRI also plans to test another BioHub platform – a “bioengineered scaffold,” a sponge-like disc made of clinical-grade silicone – also utilizing the omentum as a transplant site. Researchers are in discussions with the FDA about additional pre-clinical testing that the regulatory agency has required before approval of that pilot clinical trial in the U.S. can be granted.

“We will test both the biodegradable scaffold and the bioengineered scaffold to see which approach is better and demonstrates greater benefits for patients with diabetes. Both approaches will allow us to add all the components necessary for developing a BioHub mini organ,” adds Dr. Ricordi.

For more information on the pilot trial and to download the Islet Transplantation Application form, go here.

The DRI has also made progress in the other strategic areas comprising the BioHub, which include methods to protect the insulin-producing cells from the immune system, as well as a means of developing an unlimited supply of cells. 

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Contact:
Lori Weintraub, APR
lweintraub@drif.org
954.964.4040

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