The purpose of this study is to evaluate the safety, tolerability, and effectiveness of an investigational islet cell infusion, called VX-880, in individuals with type 1 diabetes with severe low blood sugar (hypoglycemia) and impaired hypoglycemic awareness. The goal of this infusion is to provide replacement cells for the ones that have been lost or don’t work properly in people with diabetes.
Eligible participants must meet the following key criteria:
There are additional eligibility requirements, which the study doctor will explain to you.
The infusion of islet cells will occur up to 90 days after the screening visit. Prior to a planned islet cell infusion, you will be admitted to the hospital for approximately three days and will remain in the hospital for approximately four more days after the infusion for safety monitoring. There may be a second infusion if you are enrolled in the first part of the study. The follow-up period is approximately five years following your final infusion. After these initial five years, you may be asked to participate in a separate long-term follow-up study.
During the study:
If your loved one is living with type 1 diabetes, share this website with them today, or talk to their doctor for more information.
See if you may qualify
This study was placed on clinical hold by the United States (US) Food and Drug Administration (FDA) on April 26, 2022. This clinical hold applies to screening, enrollment and dosing activities in the US.