Islets from stem cells
VX22-264-101 (New Study)
A Phase 1/2 Study to Evaluate the Safety,
Tolerability, and Efficacy of VX-264 in Subjects With
Type 1 Diabetes Mellitus.
Funded by VERTEX
I am writing to inform you of the VX22-264-101 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
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 VX22-264-101 Study.
The purpose of the VX22-264-101 Study is to learn more about how safe, tolerable, and effective an
investigational cell-based therapy, called VX-264, is in adults with T1D. VX-264 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-264 consists of cells designed to produce insulin contained within devices designed to protect the cells from the immune system.
Vx-264 device will implanted surgically behind muscles of your abdominal wall under the general anesthesia.
There will be no need to take any anti-rejection (immunosupression) medications.
Eligible participants must:
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
NOT have had an islet cell transplant, an organ 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
NOT have more than one severe hypoglycemic event (very low blood glucose requiring help from other people) annually
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 VX22-264-101
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 VX22-264-101 Study, visit 264.T1DStudy.com or call
[Study Coordinator Name] at [PI Phone]. [Study Coordinator Name] 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