3D printed NICHE shows potential to treat Type 1 diabetes

In a study published in Nature Communications, a team led by Houston Methodist delivered islet cells and immunotherapy directly into NICHE, a 3D printed device analogous to a bioengineered pancreas. The treatment is said to have restored healthy glucose levels and eliminated Type 1 diabetes symptoms in animal models for over 150 days while avoiding severe adverse effects of anti-rejection therapy by administering immunosuppressive drugs where the transplanted islet cells were located.

Type 1 diabetes is caused by an autoimmune reaction that destroys the cells in the pancreas that make insulin. Regular insulin injections are the most conventional treatment but attaining close control of glucose levels remains challenging and cumbersome for patients. In more severe cases, patients may need pancreas and kidney transplants, or they may qualify for an islet cell transplant, where the islet cells of a deceased pancreas donor are harvested, processed and then transplanted into the Type 1 diabetes patient’s liver.

These transplants can help improve a patient’s symptoms but one of the biggest challenges is the need for immunosuppressive drugs for the rest of their lives to avoid transplant rejection.

The NICHE (Neovascularised Implantable Cell Homing and Encapsulation device), created in the Department of Nanomedicine at Houston Methodist Research Institute, is a flat device placed under the skin comprised of a cell reservoir for the islets and a surrounding drug reservoir for localised immunosuppression therapy. It is the first platform to combine direct vascularisation and local immunosuppression into a single, implantable device for allogeneic islet transplantation and long-term Type 1 diabetes management. The team said direct vascularisation is fundamental for supplying nutrients and oxygen for maintaining the viability of transplanted islet cells.

“A key result of our research is that local immunosuppression for cell transplantation is effective,” said Alessandro Grattoni, Ph.D., corresponding author and chair of the Department of Nanomedicine at Houston Methodist Research Institute. “This device could change the paradigm of how patients are managed and can have massive impact on treatment efficacy and improvement of patients’ quality of life.”

The NICHE incorporates ports for the refilling of drugs as needed. The researchers refilled the drug reservoirs every 28 days, which is comparable to other long-acting drugs that are clinically available.

Grattoni’s team is working on scaling up the NICHE technology for clinical deployment, for which drug refilling may only be needed once every six months. The ability to refill the NICHE technology allows for long-term use in patients. Further, changes in drug formulations or concentration could extend refill intervals to once each year.

Grattoni and his collaborators will expand this research over the next few years, with the end goal of testing the NICHE’s safety in humans in about three years.