In March 2008, we were awarded $1 million by the National Institute of Diabetes and Digestive and Kidney Diseases of the U.S. National Institutes of Health (NIH) to develop new automated laboratory equipment useful in diabetes research and treatment. The two-year PhaseII Small Business Innovation Research (SBIR) grant follows a $100,000 Phase I SBIR award in 2007, which proved the applicability of quadrupole magnetic sorting (QMS)to diabetes treatment.
Type 1 diabetes, also known as juvenile diabetes, is an autoimmune disease where the patient's ability to produce insulin and regulate his or her blood sugar has been compromised. It can lead to serious complications including cardiovascular disease, kidney failure, retinal damage (leading to blindness), nerve damage, and diabetic induced coma. Other complications may include microvascular damage leading to poor healing of wounds and, in many cases, amputation of the feet.
Among the hopes for curing type 1 diabetes is the transplantation of Islets of Langerhans ("islets"for short) from the pancreas of an organ donor to the liver (or other suitable organ) of the recipient. Pancreatic islets are the clusters of cells found in the pancreas that produce insulin and regulate blood sugar levels. Islet transplantation has been shown to restore insulin production and blood sugar regulation in patients participating in clinical studies.
However, successful diabetes reversal in clinical trials typically requires two, three, or more donor organs per recipient, and donated organs already are in short supply. The primary goal of QMS is to obtain a higher yield of high quality, viable islets from a donor pancreas (human cadaver or pig) to improve the transplantation process. Current methods result in inadequate yield, viability, purity and reproducibility.
Medical researchers at the University of Minnesota began exploring magnetic separation of pig islets following a publication from the Netherlands in which rat islets were found to take up magnetic particles, which responded to magnetic extraction. After conducting initial studies, the medical researchers invited Techshot to provide instrumentation and engineering support to further the separations process.
Using a QMS device we originally designed for smaller-scale separations, researchers proved that magnetically labeled islets could be purified by QMS. And when transplanted, the magnetically labeled islets were capable of restoring insulin production in small laboratory animals.
The recent $1 million NIH award is being used to construct new QMS equipment (including disposables) that can purify islets on the larger scale required for human transplants, which will be proven in pig studies in the laboratory. Using QMS technology it finally may be possible to use only a single donor organ to treat each transplant recipient.