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Trial Testing Stem Cell Implants for Type 1 Diabetes

Diabetes word cloud

(905513, Pixabay)

21 Jan. 2019. A clinical trial is underway testing the safety of implanted stem cells to generate working beta cells in the pancreas that produce insulin, in patients with type 1 diabetes. The study is taking place in Belgium, a project of the Center for Beta Cell Therapy in Diabetes, testing a product developed by regenerative medicine company ViaCyte Inc. in San Diego.

Participants in the trial are people with type 1 diabetes, an inherited autoimmune disorder where beta cells in the pancreas do not produce insulin. Type 1 diabetes is diagnosed primarily in children or young adults, where the immune system is tricked into attacking healthy cells and tissue as if they were foreign invaders, in this case, insulin-producing beta cells. From 5 to 10 percent of people diabetes have the type 1 form. For this study, participants are those at high risk of complications, such as severe episodes of low blood sugar that can lead to coma or death.

ViaCyte’s PEC-Direct system being tested in the trial uses stem cells that transform into functioning beta cells. The human embryonic stem cells are contained in a biocompatible material that supports their transformation and growth into beta cells, implanted under the skin. Earlier versions of the implant protected the stem cell collection from invoking an immune response, including autoimmune reactions. The PEC-Direct system, however, encourages integration of the implant with blood vessels, because of the high risks of complications in the patient population. As a result, participants in the trial are also taking drugs to suppress immune responses.

The early-stage study is watching primarily for safety issues with PEC-Direct, particularly adverse effects, with the first individual receiving an implant. Participants are enrolled at the University Hospital of Vrije Universiteit Brussel in Belgium.

The trial is similar to a study already underway in Canada and the U.S. among adults with type 1 diabetes. That trial is also assessing safety of PEC-Direct implants, but is gauging as well participants’ production of C-peptides, an indicator of insulin production in the pancreas. Individuals with type 1 diabetes make very little or no C-peptides, thus the appearance of C-peptides in blood or urine samples would suggest restoration of insulin production.

Center for Beta Cell Therapy in Diabetes is a consortium of research hospitals and institutes, mainly in Europe, studying treatments for type 1 diabetes, particularly development of replacement working beta cells. The program is funded by European Union science initiatives and JDRF, a foundation that supports research on type 1 diabetes.

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