https://pittplusme.org/study/2325
Type 1 Diabetes Islet Cell Infusion Research Study
STUDY BASICS
Are you 18-65 years old? Have you been diagnosed with type 1 diabetes? Do you have documented severe low blood sugar (hypoglycemia) and impaired hypoglycemic awareness? You may be eligible to participate in a research study to evaluate whether one or two doses of insulin producing cells can provide better control of your blood sugar.
STUDY PURPOSE
The purpose of this research is to learn more about how safe, tolerable and effective the VX-880 Study Product is in participants with type 1 diabetes mellitus (T1D) with impaired awareness of low blood sugar and who have severe hypoglycemia. The Study Product is made up of a mixture of cells that are able to make insulin, as well as other hormones.
COULD THIS STUDY BE RIGHT FOR YOU?
- Be 18 to 65 years of age.
- Have been diagnosed with type 1 diabetes.
- Have documented severe low blood sugar (hypoglycemia) and impaired hypoglycemic awareness.
WHAT PARTICIPANTS CAN EXPECT
- A screening visit up to 90 days before the infusion.
- A procedure to infuse an investigational treatment consisting of human stem cell–derived pancreas islets called VX-880. These islets are made up of cells that replace those lost as a result of type 1 diabetes.
- A follow-up period of five years following the infusion.
IRB: STUDY21030069
- A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia
MEET THE RESEARCHER
Martin Wijkstrom ,
Martin Wijkstrom, MD, is Assistant Professor in the Department of Surgery, Division of Transplantation. He is the Director of Islet Transplantation as well as Director of the Abdominal Transplant Fellowship. Dr. Wijkstrom completed his medical degree at the Karolinska Institute in Stockholm, Sweden, and then completed his General Surgery training at Emory University and Fellowship in Transplant Surgery at Northwestern University in Chicago. He has been at UPMC since 2010 and has throughout this career worked towards the surgical treatment of diabetes. His clinical work includes pancreas and kidney transplantation and islet autotransplantation following total pancreatectomy, and his research interest started with islet xenotransplantation and is now focused on transplantation of stem cell-derived islet cells to treat diabetes.