Islets from stem cells
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
for Clinical Islet Transplantation.
Funded by VERTEX
I’m writing to inform you of a new clinical research study of an investigational infusion in individuals who
have been diagnosed with type 1 diabetes with severe low blood sugar (hypoglycemia) and impaired
My office is conducting this study, along with other qualified and well-trained clinical research study doctors in locations around the United States. This letter is intended to share information about the study with you so that you can consider participation.
The purpose of this type 1 diabetes study is to evaluate the safety, tolerability, and effectiveness of an investigational islet cell infusion called VX-880. The word “investigational” means this medication is not
yet approved for use by the Food and Drug Administration (FDA) in the United States or other regulatory
agencies in Canada, Europe, or elsewhere.
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. The islet cell infusion does not require a surgery but patients will need to take anti-rejection (immunosupression) medications.
Eligible participants must meet the following key criteria:
• Male or female between the ages of 18 and 65 (inclusive)
• Diagnosed with type 1 diabetes with documented severe hypoglycemia and impaired
• Blood type A or AB
• Willing and able to comply with the study instructions
There are additional eligibility requirements, which the study doctor will explain to you. 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.
If you are interested in learning more about this study, please contact Clinical Study Manager Lindsay Basto at Lindsay.Basto@uchospitals.edu or call 773-702-2504.
Lindsay will tell you more about the study, including any risks and benefits of participation.
Thank you for considering this type 1 diabetes clinical research study.
John Fung M.D. Ph.D
Chief, Transplantation Institute,
University of Chicago
More information on clinical trials.gov
Results of the first 2 patients presented during the Scientific Sessions American Diabetes Association