Sernova Cell Pouch for Type 1 Diabetes

This trial tests a new device called the Sernova Cell Pouch™ for individuals with Type 1 Diabetes who cannot detect dangerously low blood sugar levels and have experienced severe low blood sugar events. The Cell Pouch is implanted in the body, creating a special space for insulin-producing cells to live and function. The goal is to determine if this setup can safely support the long-term survival and function of these cells, potentially improving blood sugar control. Individuals who have had Type 1 Diabetes for at least five years, frequently monitor their blood sugar, and have experienced severe low blood sugar episodes might be suitable candidates for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative device.

The trial requires that you stop taking any anti-diabetic medication other than insulin within 4 weeks of the transplant. If you are on systemic steroids, you may need to adjust your dosage unless it's 5 mg or less of prednisone daily or an equivalent dose of hydrocortisone for replacement purposes.

In earlier studies, the Sernova Cell Pouch demonstrated promising safety results for people with Type 1 Diabetes. Research shows that islet cells, which help produce insulin, can survive in the Cell Pouch for one to more than five years, indicating that the treatment is generally well-tolerated over time. The Cell Pouch integrates into the body, forming many tiny blood vessels that enhance the function and longevity of the transplanted cells.

Unlike the standard treatments for Type 1 Diabetes, which typically involve insulin injections or pumps, the Sernova Cell Pouch™ offers a novel approach by implanting a small device under the skin to house insulin-producing cells. This innovative method aims to restore the body's natural ability to regulate blood sugar, potentially reducing or eliminating the need for regular insulin administration. Researchers are excited because it could significantly improve the quality of life for patients with severe hypoglycemic episodes and hypoglycemia unawareness, providing a more stable and long-term solution compared to current treatments.

Research has shown that the Sernova Cell Pouch, which participants in this trial will receive, holds promise for treating Type 1 Diabetes. This device supports insulin-producing cells, known as islets, in functioning effectively. Studies have found that these islets can survive and function well for over five years. The Cell Pouch creates a natural, blood-rich environment that promotes cell thriving. Specifically, patients in those studies reported an improved quality of life after receiving this treatment. These findings suggest that the Sernova Cell Pouch could be a viable option for managing Type 1 Diabetes, particularly for those experiencing severe low blood sugar episodes.²³⁴⁶⁷