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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03513939 | A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation | PHASE1 | ACTIVE NOT_RECRUITING | 17 | — | — | Feb 7, 2019 | Oct 1, 2026 | Feb 25, 2026 | 1 | United States |
Safety will be assessed by evaluating the incidence and severity of adverse events (AEs) determined to be probable or highly probable to the Cell Pouch following initial Cell Pouch implantation, at the time of islet transplantation, and following islet transplantation, and throughout the study up to 365 days ±14 days post-islet transplantation
| Arm | Type | Description |
|---|---|---|
| T1D Cell Pouch Recipients | EXPERIMENTAL | Eligible Type 1 Diabetes Mellitus (T1D) subjects with hypoglycemia unawareness and a history of severe hypoglycemic episodes undergoing Sernova Cell Pouch intervention |
| Name | Type | Description |
|---|---|---|
| Sernova Cell Pouch | COMBINATION_PRODUCT | The Sernova Cell Pouch will be implanted against the rectus abdominis. The patient will receive either an 8-plug or 10-plug Cell Pouch configuration depending on Cohort assignment. A minimum of three weeks after Cell Pouch implantation, immunosuppression will be initiated and optimized for another 3 weeks. This will allow for proper vascularization of the Cell Pouch chambers and the patient to be stabilized on immunosuppression prior to islet transplantation. A mass of highly purified islets will be transplanted in the Cell Pouch. Patients who elect to retain the Cell Pouch after completion of the study will be asked to consent to long term safety follow-up, with data collected beyond the study scheduled visits every 3 months for up to 5 years until the last Cell Pouch explant (and then for a minimum of 3 months thereafter). |
Inclusion Criteria: 1. Male and female patients 18 to 65 years of age. 2. Ability to provide written informed consent. 3. Mentally stable and able to comply with the procedures of the study protocol. 4. Clinical history compatible with Type 1 Diabetes Mellitus (T1DM) with onset of disease at \<40 y...