Vertex Pharmaceuticals recently announced it has launched a clinical research study for an investigational cell therapy in type 1 diabetes (T1D) patients. As you may know, clinical research studies are carefully designed and conducted in people to see if an investigational medicine is safe and effective. Vertex is looking for adults ages 18 to 65 with type 1 diabetes in the U.S. who experience severe low blood sugar (hypoglycemia) events and impaired hypoglycemia awareness to participate in this clinical research study.
Vertex seeks to evaluate an investigational fully differentiated, stem cell derived islet cell infusion therapy, called VX-880, in people with T1D who meet study criteria to see if it can work and whether it is safe. The goal of this infusion, which is delivered intravenously (through IV), is to provide replacement islet cells for the ones that have been lost or don’t work properly in people with T1D.
Participants in the study will receive ongoing immunosuppressive medication to protect the new islet cells. These immunosuppressive medications are similar to the ones people who undergo an organ transplant receive. The follow-up period is about five years following a participant’s final infusion. Study visits are less frequent after the initial 2-year follow-up (e.g. every 6 months). Participants and their study doctor may choose to have some of the study visits at the participant’s home with a home health nurse, allowing for a lower number of times that participants must travel to the study site. There are options to complete some visits remotely throughout the study to minimize necessary travel.
If qualified for the research study and an individual chooses to participate, he/she will receive all study-related medications and procedures at no cost. In addition, participants may also be compensated for study-related time and reimbursed for travel.
New medicines are made possible by the volunteers who participate in clinical research studies. Vertex encourages patients to speak first with their doctor about their potential eligibility to volunteer and enroll in a clinical research study. For more information, please visit Type1DStudy.com
