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BioHub FAQs

What is the BioHub? What will the BioHub be made of?

How will the BioHub control blood sugar levels – highs as well as lows? What about the need for glucagon to prevent hypoglycemia? Will the type 1 diabetic need an external source of glucagon?

When will the BioHub be available to patients?

Who will be able to get a BioHub? Will it be available to people of all ages who have type 1 diabetes? What about those with type 2 diabetes?

Why are DRI researchers confident this will restore natural insulin production?

If insulin-producing cells need the spacing and structure to prevent clumping, which the scaffold will provide, how is this accomplished in the venous sac?

Will the BioHub need to be replaced or reloaded with cells and other agents over time? If so, how often? Will there be issues trying to find adequate veins for forming the venous sac?

Is this concept of a venous sac for cell therapy or "mini organ" currently used for any other treatment therapy?

Are there any risks associated with having a BioHub implanted?

Will the BioHub be covered by insurance?


What is the BioHub? What will the BioHub be made of?
The DRI BioHub is a bioengineered “mini organ.” It's designed to house healthy insulin-producing islet cells, which sense blood sugar and release the precise amount of insulin needed to maintain normal blood sugar levels -- in real time.

The BioHub platform seeks to mimic the critical elements of the native pancreas and will provide:

  • Adequate spacing for each islet
  • The necessary levels of oxygen and other nutrients
  • Promote vascularization
  • Incorporate helper cells and growth factors
  • The ability to use temporary local, low-dose agents within the BioHub rather than the generalized, systemic anti-rejection drugs currently required for all transplant recipients.
  • Utilization of a thin (conformal) coating encapsulation technology to protect islets from immune attack. Special polymers are being used to coat -- or "shrink wrap" -- the islets to provide a protective barrier.

DRI researchers are developing and testing several platforms to serve as a BioHub. Among these is a biocompatible silicon scaffold -- a porous sponge-like material.  Another approach is to use a patient's own vein within the abdomen. Researchers would tie off both ends of a segment of this vein to create a "venous sac."  The islets would then be loaded within that vein segment.  This approach is a collaborative effort between scientists at the DRI-Tiblisi, Georgia, the DRI-Miami and the DRI-Edmonton, Canada.

Living cells, together with oxygen promoters, anti-inflammatory agents and growth factors can be incorporated into either of these platforms to create an optimal environment for the long term health of the islets.

How will the BioHub control blood sugar levels – highs as well as lows? What about the need for glucagon to prevent hypoglycemia? Will those with type 1 diabetes need an external source of glucagon?
Insulin-producing "beta" cells are transplanted within islets, which are clusters of endocrine cells. These clusters already include glucagon-producing "alpha" cells. As in a healthy pancreas, these and other cells within the islets work together to regulate and maintain normal blood sugar levels. So, no additional source of glucagon will be needed.

When will the BioHub be available to patients?
We are aggressively moving the BioHub toward clinical trials. With that goal in mind, we are using materials that should more easily receive FDA approval. We anticipate the first clinical trials will take place in 2014. The regulatory path already started in February 2013.  They will test the use of the silicone scaffold to house the islets. The study will also evaluate the placement of this BioHub platform within the omentum (abdominal lining) and its ability to regulate blood sugar levels. Future trials will incorporate the oxygen promoters, helper cells and other agents to optimize the BioHub environment.

Who will be able to have a BioHub? Will it be available to people of all ages who have Type 1 diabetes? What about those with Type 2?
For now, the BioHub is focused on type 1 diabetes. However, it could benefit many people with Type 2 Diabetes by providing healthy insulin-producing cells to over-ride or replace their lost and/or defective cells. This would restore natural insulin production in response to rises in glucose.

Participants for these initial trials will be required to meet the same criteria as those eligible for current Clinical Islet Transplantation (CIT) trials which utilize the liver as a transplant site. Some of the criteria include ages 18-65, more than five years of diabetes, and the inability to sense low blood sugar (hypoglycemic unawareness). Our ultimate goal is to replace is to avoid the need for any immunosuppressive drugs  which will open the door to treat children and adults alike. 

Why are DRI researchers confident this will restore natural insulin production?
Our clinical trials have shown that we can regulate blood sugar levels by transplanting islets into patients with type 1 diabetes and that those cells can function for years. So, in patients with the most severe form of type 1 diabetes, precise regulation of blood sugar can be provided and maintain normal blood sugars.

But the duration of the cure is limited. And the requirement of systemic anti-rejection drugs, to prevent rejection of the foreign islets, presents health risks to the transplant recipient.

With the BioHub, we are harnessing the natural power of islets to provide natural regulation of blood sugar levels by addressing the issues of rejection and long-term function.

By providing a better site to place the islets and incorporating strategies to eliminate the need for chronic, generalized anti-rejection therapy, we believe the BioHub will provide a superior treatment option, or cure, for those with type 1 diabetes.

If insulin-producing cells need spacing and structure to prevent clumping, which the scaffold will provide, how is this accomplished in the venous sac?
The requirement for adequate spacing will be addressed in both the scaffold and venous sac. 

The goal for the venous sac is to use similar natural products for oxygen delivery, helper cells and microbeads that will assist in providing the ideal microenvironment for the islets. There are additional options for spacing and structure of the islets within the venous sac, as the external sac provides some mechanical protection. Clinically available scaffolds, such as fibrin gels, could be used. Also, the venous sac already contains endothelial cells which are critically important to islet health and function. 

Will the BioHub need to be replaced or reloaded with cells and other agents over time? If so, how often? Will there be issues trying to find adequate veins for forming the venous sac?
It is possible the BioHub may need to be replaced, but our goal is to develop a permanent biological cure -- especially when successful immune tolerance strategies are included in the BioHub platform. 

We already know an islet cell transplant can work for more than 15 years. Once tolerance induction becomes reality, there is no reason to believe that a biologic cure will exhaust its capacity.  Most long term failures so far have been related to toxicity of the immunosuppressive drugs or chronic rejection/recurrence of autoimmunity.

We anticipate that by moving the transplant site out of the liver, providing an environment that more closely mimics the conditions in the native pancreas and offers the islets protection from the immune system, we will see significant improvement in the lifespan and function of the transplanted cells.  As the BioHub program advances and moves into clinical trials, we will learn more.

Should it be necessary to replace the BioHub, and if the venous sac is determined to be the optimal environment to house the cells, finding adequate veins will not be a challenge. The veins being used are abdominal veins that mimic the blood supply of the native pancreas. The advantage of creating a "designated" BioHub environment is knowing where the cells are, the ability to make changes within and having the ability to retrieve it, if needed. This is not the case with the liver site.

Is this concept of a venous sac for cell therapy, or "mini organ," currently used for any other treatment therapy?
We are not aware of the venous sac concept being used for any other therapy. Our "invention" has not yet been tested in other systems and the paper published in Transplantation in 2012 was the first describing such an application. 

Are there any risks associated with having a BioHub implanted?
However small, all surgical procedures carry potential risks for opportunistic infections, bleeding, adverse effects to medication, anesthesia, etc.

Also, with all transplants of unrelated donor organs and living cells, such as islets, the recipient is required to take powerful drugs. These drugs block his or her immune system from seeing the cells as "foreign" and attacking -- or, "rejecting" --  the donor tissue.

These anti-rejection drugs are harsh and often cause side effects, including toxicity to the newly transplanted islets. The drugs also increase the risks for infection, skin cancer and reductions in white and red blood counts. The components planned for the BioHub have the objective to eliminate the need for these systemic anti-rejection drugs with complete elimination of the side effects related to their long-term use.

As for the biocompatible materials used in the BioHub, these have been tested and are routinely used in other clinical procedures.

Will the BioHub be covered by insurance?
As with any experimental procedure, there will be a series of steps to show safety and effectiveness in both pre-clinical and clinical studies.

The use of clinically approved materials and cell products should provide preliminary data for this approach. However, combining these components will be a step-by-step process to gain sufficient data to present to FDA and for third party reimbursement.

The DRI BioHub mini organ mimics the native pancreas
Learn more about the development of the BioHub mini organ to restore natural insulin production in those living with diabetes.
Watch the BioHub video>>


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A DRI BioHub contains real insulin-producing cells plus other cells and agents to provide long term survival and function.
One of the BioHub platforms in testing is a porous, sponge-like material the size of a quarter. Thousands of islet cells (red) nestle within the small pores. Critical oxygen generators (blue), helper cells (yellow) and other agents can be added to a BioHub to keep islet cells healthy, protected and able to function long term.

By tying off a segment of a vein, DRI researchers would create a "venous sac" as a platform for a BioHub.

DRI researchers are creating a venous sac for a BioHub by tying off the ends of a segment of a vein.
By tying off a segment of a vein in the abdomen, DRI researchers create a "venous sac" to serve as a natural container for a BioHub. An adjacent artery would provide critical oxygen and nutrients.

 

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