A New Site for a BioHub Platform – DRI all set to undertake anew test!
The Food and Drug Administration (FDA) has given approval to the Diabetes Research Institute to go ahead with the Phase I/II clinical trial where the omentum will be tested. The omentum is inside the abdomen and the lining looks like an apron. This test will try to find out if it is a suitable location for a DRI Biohub. In this initial trial, the researcher will transplant into the omentum the donor islet cells within a scaffold that is biodegradable in nature and that was initially considered as the potential BioHub platform. This scaffold is created out of the patient’s own plasma (which comprises the liquid part of the blood). The reasearchers are taking the islet cells and combining it with the plasma. Thrombin, a commonly used enzyme is also mixed with this preparation, which is then applied to the omentum. When all the components are mixed, it creates a gel like solution that sticks to the omentum and ensures that the islets remain in place. This portion will then be folded and stitched to create a pouch around the scaffold.
Over a period of time, the human body will absorb this gel leaving behind the islet cells while new blood vessels are formed that will help to support the survival and function of the cell. All those individuals upon whom the trial will be carried out, will be administered immunosuppressive drugs.
The DRI is now interviewing individuals for this clinical trial and other trials that will be carried out in the future. They are trying to make a databank of as many individuals as possible so that the chances of donor matching and the utilization of pancreases are high.
Frequently Asked Questions (FAQ)
Is this pilot clinical trial testing the DRI BioHub?
This clinical trial is Phase I/II that will represent the first stage of testing the omentum as an alternative site inside the body where one can transplant the islet cells. It will also test one of the platforms to see whether it is suitable for DRI biohub. This bio hub is a platform technology is made up of several components that work together in order to mimic the native pancreas.
When will this pilot trial begin?
The DRI’s clinical department is aggressively interviewing patients as it wants to begin this clinical trial by the end of the year.
What are the criteria for this pilot trial?
The patient has to be within the age group of 18 to 60 years with type1 diabetes.
Severe hypoglycemia
Unaware that the individual has low blood sugar level.
Will anti-rejection drugs be needed in this trial?
Yes. Although the DRI’s aim is to eliminate the use of any systemic drug, but initially the immunosuppression drug will be used as is done in case of islet processing and matching criteria. But over a period of time this will be avoided.
Will everyone who participates be given the same treatment or will a placebo be involved?
Each and every individual participating in the test will be given the same treatment. No demarcation will be made. Placebo is not used in organ and tissue transplantation studies however, they do compare the current trial results with the previously conducted tests in order to determine the effects of a new therapy.
This research, if successful, will open many doors for the cure and treatment of diabetes. Individuals who suffer from this ailment, usually are unable to lead a normal lifestyle as they have food restrictions and different checkups and insulin injections to take and so on. In short, one needs to be very careful. A little bit of ignorance and it can turn serious. Hence, one needs to be extremely careful and follow the doctor’s instruction to the last letter. The success of this research will make sure that the insulin level is well under control so that the concerned person can lead a healthy life.