It’s about the thickness of a wafer and not much bigger than a postage stamp and it might revolutionize the treatment of type 1 diabetes.
It’s called the NICHE, which stands for Neovascularized Implantable Cell Homing and Encapsulation device. Developed by researchers in the Department of Nanomedicine at Houston Methodist Research Institute, it can be thought of as a kind of bioengineered pancreas. In a paper recently published in the journal Nature Communications, the inventors described how they used the NICHE for two functions: 1) to deliver transplanted islet cells — cells that produce hormones like insulin that enter the bloodstream and help regulate blood sugar — into the pancreas and 2) to administer immunotherapy that prevents the pancreas from rejecting the transplanted cells.
According to its developers, treatment by means of NICHE implantation under the skin eradicated type 1 diabetes symptoms and restored optimal blood sugar levels in animals for more than 150 days. By administering the immunosuppressive drugs specifically at the site of the transplanted islet cells, the researchers were able to avoid the undesirable effects of antirejection therapy.
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The NICHE is comprised of two reservoirs: one for the islet cells and another surrounding one for the immunosuppression therapy. The device (or nanodevice), the developers say, is the first platform to combine direct vascularization (with functional vessels) and local immunosuppression into a single, implantable device for islet transplantation and long-term type 1 diabetes management. Direct vascularization, they explain, is needed to supply nutrients and oxygen to the transplanted islet cells. According to study author Alessandro Grattoni, PhD, chair of the Department of Nanomedicine at Houston Methodist Research Institute, “A key result of our research is that local immunosuppression for cell transplantation is effective. 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 device contains silicon ports that allow for the refilling of the drugs when necessary. In their experiment, the researchers refilled the drug reservoirs approximately once a month, which is about the same length of time used with other long-acting drugs, such as those used for migraines and treating HIV. The research team, however, is working on a version that would need drug refilling every six months, which will allow long-term use of the device. It might even be possible, the developers say, to develop a type that requires drug refilling once a year. As Dr. Grattoni has explained, “Design of the NICHE prioritizes clinical considerations of efficacy, safety, and user acceptability. Cell and drug refilling of the NICHE reservoirs is transcutaneous and so can be done without removing the device, which allows for ease of drug replenishment when needed, thus extending implant lifespan potentially for the lifetime of patients.”
The research team plans to expand their research over the next few years and hopes the NICHE can be tested in humans in abut three years. A newly awarded $2.8 million grant will let the scientists further examine the device in animal models. They plan to study the ability of the stem cells to stimulate vascularization (blood cell growth) within the NICHE as well as modulate the immune microenvironment to foster islet transplantation. Other tests, the researchers say, will eventually allow them to evaluate the device’s ability to restore normal amounts of blood sugar. They even anticipate that their research could lead to cell therapies for other diseases.
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