A clinical research study is a carefully designed research study conducted in people to determine if an investigational medicine is safe and effective. We encourage patients to speak first with their doctor about their eligibility to enroll in a clinical research study. New medicines are made possible by the volunteers who participate in clinical research studies. Thank you for your consideration of this important study.
While you may or may not benefit directly from this study, your participation could play an important role in the health of future generations with type 1 diabetes.
Taking part in this study is your choice, and you may leave the study at any time for any reason. You should consult the study doctor and staff about concerns and questions you have at any time during the study.
Before you can take part in this study, you will be asked to sign an informed consent form confirming that you have been informed about the details of the study and agree to participate. You will then need to attend the screening visit(s) to complete initial tests and assessments to see if you are eligible to participate. After all necessary tests and assessments have been completed, and if you are eligible to participate, you may enter the study and may be able to receive the investigational infusion.
If you qualify, you will receive all study-related medications and procedures at no cost. You and your study doctor may choose to have some of the study visits at your home with a home health nurse, allowing for a reduced number of times that you must travel to the study site. You may also be compensated financially for your study-related time and reimbursed for travel.
The infusion of islet cells will occur up to 90 days after the screening visit, but it may happen sooner. 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.
Learn more about this T1D clinical research study.
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.