Currently, Drs. Trucco and Giannoukakis are conducting a clinical trial of their leukapheresis-based dendritic cell approach in humans at Childrens. This Phase 1 clinical trial has been approved by the U.S. Food and Drug Administration (FDA).
Our ultimate goal is to offer this dendritic cell vaccine or microsphere-based therapy to children at risk for or newly diagnosed with type 1 diabetes. We want to make the procedure as safe and comfortable as possible, Dr. Giannoukakis said.
The trial began late last year and enrollment is ongoing. The study, which plans to enroll a total of 15 adults over age 18 with type 1 diabetes, is expected to conclude later this year.
If the leukapheresis-based approach continues to show exceptional safety, the researchers hope to launch a national clinical trial that will assess the effectiveness of the dendritic cells in pediatric patients to prevent diabetes or reverse the disease right after it is clinically confirmed. At a later date, it is anticipated that Baxter Healthcare will collaborate with Drs. Trucco and Giannoukakis in a clinical trial utilizing the unique microsphere-based approach.
Leukapheresis is a process that allows for the collection of dendritic cell precursors from the patients in the study, which takes two to four hours. After the precursors are collected, they are treated in the lab with specific growth factors that turn them into dendritic cells. The growth factors are also combined with short DN
|Contact: Marc Lukasiak|
Children's Hospital of Pittsburgh