Dear Patient, 

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I am writing to inform you of the VX24-880-102 Study, a clinical research study for an investigational cell based

therapy in adults with type 1 diabetes (T1D) who are dependent on insulin injections to manage

their diabetes.

 

My office is conducting this study, along with other qualified and well-trained clinical research study doctors in locations around the United States, Canada, the United Kingdom, and Europe.

 

This letter is intended to share information about the study with you so that you can consider participation.

If you are living with T1D, we invite you to consider taking part in the VX24-880-102 Study.

 

The purpose of the VX24-880-102 Study is to learn more about how safe, tolerable, and effective an

investigational cell-based therapy, called VX-880, is in adults with T1D who already had kidney transplantation.

 

VX-880 is considered investigational, which means it is not approved as a marketed product by Health Canada, the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), or any other

regulatory (government) authority.

 

VX-880 consists of cells designed to produce insulin which are infused during minimally invasive procedure into patient liver under local anesthesia. Patient will continue the same anti-rejection medications, which have been taking for kidney graft protection, possibly with minor modifications. 

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VX-880 cell product have been tested clinically in patients with T1DM without kidney transplant since 2020 with promising outcomes. Majority of 12 patients became insulin free after  the therapy. 

More information about preliminary outcomes you can find here. 

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Eligible participants must:

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• Be between the ages of 18 and 65 (inclusive)

• Have had insulin-treated T1D for at least 5 years

• Have blood type A or AB

• had kidney transplant in the past with a stable function

• NOT have had an islet cell transplant, or cell therapy

• NOT have advanced complications associated with diabetes, including untreated advanced diabetic retinopathy, diabetic nephropathy, skin ulcers, or amputations attributable to diabetes

 

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. All participants in the VX24-880-102

study will receive the investigational therapy. Participants and their study doctor may choose to have

some of the study visits conducted at the participant’s home with a home health nurse, allowing for a

reduced number of times that they must travel to the study site.

 

Participants may also be compensated financially for study-related time and reimbursed for travel.

 

If you are interested in learning more about the VX24-880-101 Study, visit 880.T1DStudy.com or email

our Study Coordinator Hannah Gilkey Hannah.Gilkey@bsd.uchicago.edu 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

 

Transplantation Institute,

University of Chicago

 

                                                                                                                                                        

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