Type 1 Diabetes Research Study
Researchers at leading medical centers across the United States are conducting a clinical research study to evaluate an investigational cell therapy for adults recently diagnosed with type 1 diabetes (T1D).
Fast Facts
Diagnosed with type 1 diabetes in the last 3 months
Ages 18-45
Overall in Good Health
Conducted in Multiple Locations
Study Background
The POLARIS Study is evaluating whether a one-time, investigational cell therapy can help slow or stop the progression of type 1 diabetes by restoring immune balance.
Type 1 diabetes occurs when the immune system mistakenly attacks the insulin-producing cells in the pancreas. Even after diagnosis, many people still have some remaining insulin-producing cells, but these cells may continue to be damaged over time. Current treatments manage blood sugar levels but do not address the underlying immune cause of the disease.
The POLARIS Study is testing an investigational therapy called GNTI-122, made from a participant’s own blood cells. These cells are engineered to help correct the immune imbalance that contributes to type 1 diabetes. The study involves a single dose of the investigational therapy, followed by regular follow-up visits to monitor safety, immune response, and diabetes progression. This research is being conducted at multiple clinical sites nationwide.
Study Background
The POLARIS Study is evaluating whether a one-time, investigational cell therapy can help slow or stop the progression of type 1 diabetes by restoring immune balance.
Type 1 diabetes occurs when the immune system mistakenly attacks the insulin-producing cells in the pancreas. Even after diagnosis, many people still have some remaining insulin-producing cells, but these cells may continue to be damaged over time. Current treatments manage blood sugar levels but do not address the underlying immune cause of the disease.
The POLARIS Study is testing an investigational therapy called GNTI-122, made from a participant’s own blood cells. These cells are engineered to help correct immune imbalance that contributes to type 1 diabetes. The study involves a single dose of the investigational therapy, followed by regular follow-up visits to monitor safety, immune response, and diabetes progression. This research is being conducted at multiple clinical sites nationwide.
Additional Information
The purpose of the POLARIS Study is to evaluate the safety of GNTI-122 and to see whether a single dose of this investigational cell therapy can help preserve remaining insulin-producing cells in adults recently diagnosed with type 1 diabetes.
You may be eligible for this study if you meet the following criteria.
Inclusion Criteria:
- Diagnosed with type 1 diabetes in the last 3 months
- Ages 18-45
- Overall in good health
- No other significant or unstable medical conditions
- Not participating in another interventional clinical study
- Not pregnant or breastfeeding
- Willing to use contraception
- Not diagnosed with type 2 diabetes
The POLARIS Study is a multi-center clinical trial being conducted at leading research institutions across the United States, including:
- City of Hope Medical Center – Duarte, CA
- University of California, San Diego – San Diego, CA
- University of California, San Francisco – San Francisco, CA
- University of Florida – Gainesville, FL
- University of Miami, Diabetes Research Institute – Miami, FL
- Joslin Diabetes Center – Boston, MA
- University of North Carolina at Chapel Hill – Chapel Hill, NC
- Duke University –Durham, NC
- Columbia University – New York, NY
- Icahn School of Medicine at Mount Sinai – New York, NY
Additional locations may be added over time.
If you choose to participate, your involvement may include:
A phone screening to determine initial eligibility
An in-person screening visit, including medical history and lab tests
Collection of white blood cells through a procedure called leukapheresis
A one-time administration of the investigational therapy (GNTI-122)
Follow-up visits at the study site to monitor safety, immune response, and diabetes progression
All study procedures are explained in detail before participation, and you may leave the study at any time.
Participants will receive compensation for time and travel, which varies by study site and follows industry standards for studies of similar complexity. Parking assistance or transportation support may also be available.
There is no cost for you to participate in our research study.