A Study of the Safety and Efficacy of Pancreatic Endocrine Cell Clusters Implanted Into the Omentum of Type 1 Diabetes Patients With Severe Hypoglycemia

Launched by SERAXIS · Oct 17, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for adults with Type 1 diabetes who experience severe low blood sugar (hypoglycemia) frequently. The researchers want to see how safe and effective it is to implant clusters of pancreatic cells into a specific area in the body called the omentum, which is a fold of tissue in the abdomen. They also aim to find the best dose of this treatment. To help prevent the body's immune system from rejecting the new cells, participants will need to take medications that suppress their immune response.

To be eligible for this trial, participants must be between 18 and 65 years old, have had Type 1 diabetes diagnosed before the age of 40, and have been dependent on insulin for at least five years. They should also have a history of experiencing severe low blood sugar episodes and be open to using a continuous glucose monitor, a device that helps track blood sugar levels. If you decide to join, you'll undergo close monitoring during the study, and the team will provide support to ensure your safety and comfort throughout the process.

Gender

ALL

Eligibility criteria

• • Key Inclusion Criteria
• • Adult 18 to 65 years with a clinical history of T1D
• • Diagnosis of T1D at \<40 years of age
• • insulin dependence for ≥5 years at pre-screening
• • Recurrent severe hypoglycemia
• • Willingness to use continuous glucose monitoring
• • Key Exclusion Criteria
• • Use of anti-diabetic agent other than insulin(s) or insulin analog(s) within 3 months of Screening
• • Weight loss medication(s) within 3 months of Screening
• • Other protocol defined Inclusion/Exclusion criteria may apply