Purpose of the Study

The purpose of this clinical research study is to learn more about how safe, tolerable, and effective an investigational cell⁠-based therapy is in adults with T1D. The therapy 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.

The standard treatment for T1D is insulin given by multiple daily injections or a pump. However, this treatment does not always sufficiently control blood sugar levels. With current available treatments, diabetes management involves a complex balance of monitoring blood sugar levels, delivering insulin, and managing lifestyle (food, activity, stress, etc.), and becomes a constant part of life. This continued burden, despite advances in treatment, is one of the reasons why research studies like this are being performed to evaluate potential treatments and therapies.

Who May Qualify

Eligible participants must meet the following criteria:

  • Be between the ages of 18 and 65 (inclusive)
  • Have had insulin-treated T1D for at least five 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

There are additional eligibility requirements, which the study doctor will discuss with those interested in participating.

Study Participation

All participants in the clinical research study will receive the investigational therapy. The therapy is comprised of cells designed to control blood sugar levels contained within devices designed to protect these cells from the body’s immune system. The therapy is implanted in the space behind the muscles of the abdominal wall in a surgical procedure under general anesthesia. All components of the therapy are investigational, including the containers that hold the devices prior to surgery and the specialized tools used to surgically implant the devices.

If you qualify to participate in the study, you will be admitted to the hospital for three or four days. You will have the investigational devices implanted on the second day you are in the hospital, and you will be monitored the next day or two after surgery. Prior to surgery, the study doctor will perform several safety assessments to ensure that you qualify to have the investigational devices implanted.

The total length of study participation in this clinical study is approximately two years and consists of the following:

Prescreening period

This period lasts up to 45 days. The purpose of the prescreening period is to determine if the potential participant is eligible to be screened for study participation. Visits during this period may be conducted remotely via home health services.

Screening period

This period lasts up to 90 days. Certain tests and procedures may be done to make sure the potential participant is eligible to participate in the study.

Study treatment period

During the study treatment period, participants will have the investigational cell-based therapy implanted, and the study team will monitor their health. Participants will be admitted to the hospital on the day before the surgery and then they will stay in the hospital for monitoring after the implant. The length of hospital stay will depend on the study doctor’s discretion but is expected to last three or four days.

Follow-up period

Participants will attend several follow-up visits to check their health after receiving the investigational cell-based therapy implant. The follow-up period will last approximately two years. Some visits during this period may be conducted remotely via home health services.

Throughout the study, the study doctor may perform a number of tests and procedures, including but not limited to:

  • Vital sign measurements

  • Physical exams

  • Electrocardiograms (ECGs)

  • Ultrasounds of the implanted device

  • Abdominal and pelvic magnetic resonance imaging (MRI)

  • Blood and urine sample collections

See if you may qualify