In September, Living Cell Technologies (LCT) revealed positive results from its JDRF-funded phase II study of DIABECELL—a unique proprietary encapsulation technology comprised of encapsulated pancreatic islets from pigs. According to LCT’s announcement, the New Zealand-based study in 14 study participants with type 1 diabetes (T1D) demonstrated the product’s safety and ability to reduce hypoglycemia, lower HbA1c levels, and improve quality of life over a 52-week period following implantation of the product. While none of the participants in the DIABECELL trial became insulin independent, this first-generation encapsulation product is the most advanced demonstration of the potential benefit of an encapsulation product in T1D.

The objective of this research was to test the safety of the implantation of DIABECELL, and whether the implanted pig islets improve blood glucose control in people with T1D.  The findings demonstrate the potential of such novel techniques to improve the management of T1D in the short term.

Led by Dr. John Baker at Middlemore Hospital in Auckland, LCT’s study used islets from specially bred pigs, and encapsulated them before implantation in the hopes of protecting them from any harmful immune response—thereby eliminating the need for immunosuppressant drugs. The protected islets were implanted into the abdomens of study participants through a laparoscopic procedure.

Encapsulation is one of JDRF’s priority areas of research toward curing T1D. Its promise lies in its potential to address two main hurdles to widespread beta cell transplantation as a cure for T1D: The limited supply of transplantable cells available, and the need for life-long immunosuppression therapy to prevent the rejection of those transplanted cells. Over the past five years, JDRF has provided more than $26 million toward
research into encapsulation and xenotransplantation (transplanting insulin-producing islets from animals into humans) through direct funding and collaborations with other organizations—including $4.6 million in FY2011—to
address these obstacles.

In addition to LCT’s research, JDRF is funding significant projects that are also developing alternative beta cell and islet encapsulation product concepts. One example is a collaboration with the biotechnology company ViaCyte to develop a first-of-its-kind encapsulated stem cell-based replacement therapy. At Emory University, JDRF-funded researchers are exploring ways to improve alginate microcapsules for pig islet transplantation. A grant
to Harvard University—partially funded by The Leona M. & Harry B. Helmsley Charitable Trust (HCT)—has made possible another prominent study at the Massachusetts Institute of Technology, researching biomaterials and delivery systems for islet encapsulation. Furthermore, in August, JDRF announced a major collaboration with the HCT to fund advanced encapsulation research at the Diabetes Research Institute at the University of Miami.

It is too soon to know when DIABECELL might be commercially available; trials in Argentina are also taking place, and phase III trials are needed to test the product on a larger number of participants, identify any adverse reactions, and explore long-term benefits of use. Still, LCT’s innovative product concept in the field of beta cell replacement could lead to exciting advancements in T1D research.