The Diabetes Research Institute received approval from the FDA to begin Phase1/2 human clinical trials for DRI’s new bioengineered medical device DRI- BIO HUB. The initial "one" person trial is now complete and within a short span insulin production within the Bio-Hub eliminated the need for exogenous insulin.
DRI’s BIO HUB is described as a “mini organ” delivering insulin to changes in BG levels in real time. The BIO HUB attempts to replicate the insulin producing beta cells natural environment providing additional oxygen and helper cells to promote cellular survival and function. These cells are to be protected from the body’s immune system by cellular encapsulation.
The components are still in various stages of development along with two different engineered platforms to house these protected cells. The first phase of the clinical trial is to test whether the omentum, the fatty pad in the patient’s abdominal area, will be a suitable site for implantation for one of the two engineered platforms.
The procedure was performed on August 18, 2015 on a 43 year old female with T1D.
NOTE: 2016 -DRI is currently running a pilot clinical trial to test the omentum as a possible location for the Bio Hub. More recruitment info available at http://www.diabetesresearch.org/pilottrial
dA detailed video describing the procedure can be found on DRI's website.