Summary:
A clinical trial of an investigational cell-based therapy for people with type 1 diabetes (T1D).
Study Purpose:
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of an investigational cell-based therapy in adults with T1D who are dependent on insulin injections to manage their diabetes. The therapy consists of cells designed to produce insulin contained within devices designed to protect the cells from the immune system. These investigational devices are implanted into the space behind the muscles of the abdominal wall. Researchers are looking to see if the therapy could potentially reduce or eliminate the need for individuals with T1D to take insulin. The total length of study participation is approximately two years.
After the prescreening and screening periods, eligible participants will enter the treatment period and have the therapy implanted. During this period, a consecutive overnight stay of up to four nights at the clinical research site will be required. The follow-up period will last approximately two years.
If you qualify for this clinical research study, 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 conducted 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.
Eligibility Criteria:
Key criteria for this study:
- 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
Other protocol-defined inclusion and exclusion criteria may apply.