New study
open enrollment 



 Islets from stem cells
transplantation


 
 
 

New islet cell product  (VX-880) transplantation for patients with T1DM

OPEN ENROLLMENT

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

Dear Patient, 

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

hypoglycemic awareness.

 

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.

 

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

    hypoglycemic awareness

•  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.

Sincerely,

John Fung M.D. Ph.D

 

Chief, Transplantation Institute,

University of Chicago

 

                                                                                                                                                     PRINT THE LETTER