A tiny gadget developed at Houston Methodist might fundamentally transform how millions of Americans with Type 1 diabetes, a chronic disease for which there is no cure, are treated. A research team led by Houston Methodist delivered islet cells and immunotherapy directly into the NICHE, a 3D printed device that resembles a bioengineered pancreas, in a study that was published in the Dec. 26 issue of Nature Communications. By giving immunosuppressive medications just where the transplanted islet cells were situated, the treatment avoided the severe side effects of anti-rejection therapy and restored healthy glucose levels and removed Type 1 diabetes symptoms in animal models for more than 150 days.
An autoimmune response that kills the insulin-producing cells in the pancreas is the primary cause of type 1 diabetes. Kidney failure may potentially result from it. Although daily insulin injections are the most common form of therapy, patients nevertheless face difficulty and burden in maintaining strict glucose control. Additionally, in more severe cases, individuals may require pancreas and kidney transplants. They may also be eligible for an islet cell transplant, in which the liver of a Type 1 diabetes patient receives the extracted, processed, and implanted islet cells of a deceased pancreatic donor.
The requirement for immunosuppressive medications for the remainder of the patient’s life in order to prevent transplant rejection presents one of the largest hurdles following these transplants, as it does with all organ transplants.
Chronic immunosuppression raises the risk of several cancers and makes patients more susceptible to infectious illnesses.
The NICHE is a flat device inserted under the skin that has a cell reservoir for the islets and a surrounding medication reservoir for targeted immunosuppressive treatment. It was developed in the Department of Nanomedicine at Houston Methodist Research Institute. In order to facilitate allogeneic islet transplantation and long-term Type 1 diabetes care, it is the first platform to integrate direct vascularization and local immunosuppression into a single implanted device. Direct vascularization is essential for preserving the survival of transplanted islet cells by feeding them with nutrients and oxygen.
“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.”
Ports are included inside the NICHE so that medications may be refilled as needed. Every 28 days, which is equivalent to other long-acting medications that are clinically accessible for the treatment of HIV or migraine prophylaxis, the researchers replenished the drug reservoirs.
The NICHE technology is being scaled up by Grattoni’s team for clinical deployment, where medication refilling could only be required once every six months. Long-term patient usage of the NICHE technology is made possible by its refillability. Additionally, adjustments to medicine concentrations or formulations might make it such that refills occur just once a year, in line with standard doctor visits.
With the final objective of evaluating the NICHE’s safety in people in around three years, Grattoni and his associates will advance this study over the following several years. Houston Methodist’s Grattoni Nanomedicine Lab specialises in implantable nanofluidics-based systems for long-term, regulated drug delivery and cell transplantation to treat chronic illnesses.
