Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06239636 | First-in-human Safety Study of Hypoimmune Pancreatic Islet Transplantation in Adult Subjects With Type 1 Diabetes | EARLY_PHASE1 | RECRUITING | 2 | — | — | Mar 8, 2024 | Jun 1, 2025 | Dec 11, 2024 | 1 | Sweden |
Number of treatment related adverse events as assessed by CTCAE v5.0
| Arm | Type | Description |
|---|---|---|
| UP421 transplantation | EXPERIMENTAL | Intramuscular transplantation of study product UP421 |
| Name | Type | Description |
|---|---|---|
| UP421 | BIOLOGICAL | Intramuscular transplantation with the ATMP UP421 composed of genetically modified human pancreatic islet cells |
Inclusion Criteria: 1. Signed informed consent for participation in the study 2. Diagnosis of type 1 diabetes mellitus (T1D); i) for ≥ 5 years and ii) diagnosed before the age of 18 years and iii) at least one or more HbA1c documented in the subject's medical journal or Swedish National...