NCT06239636

First-in-human Safety Study of Hypoimmune Pancreatic Islet Transplantation in Adult Subjects With Type 1 Diabetes

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 2 (estimated)
• Sponsor: Per-Ola Carlsson · Academic / Other
• Sex: All
• Age: 30 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The current study tests the hypothesis whether genetically modified Langerhans islet cells containing insulin-producing cells from a deceased organ donor can 1. be transplanted safely and 2. help to regain insulin production in individuals with type 1 diabetes without need in simultaneous treatment with immunosuppressive medicines. The study is an open, one-armed study where adult subjects with longstanding type 1 diabetes will receive transplantation of Langerhans islet cells (25 000 000-80 000 000) into forearm muscle. Both subjects receive active treatment. Safety is monitored with frquent follow-up visits over a year, including medical examinations, blood tests and MRI scans. Insluin producing cell function is monitored with blood samples and continuous glucose measurement. Main objective is to to investigate the safety of an intramuscular transplantation of genetically modified allogeneic human islets (study product UP421) in adult subjects diagnosed with type 1 diabetes. Secondary objectives are to study changes in beta-cell function, metabolic control and immunological response to pancreatic islets during the first year following treatment.

Conditions

• Type1diabetes

Interventions

Type	Name	Description
BIOLOGICAL	UP421	Intramuscular transplantation with the ATMP UP421 composed of genetically modified human pancreatic islet cells

Timeline

• Start date: 2024-03-08
• Primary completion: 2025-05-01
• Completion: 2025-06-01
• First posted: 2024-02-02
• Last updated: 2024-12-11

Locations

1 site across 1 country: Sweden