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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02691247 | Safety and Efficacy of CLBS03 in Adolescents With Recent Onset Type 1 Diabetes (The Sanford Project T-Rex Study) | PHASE2 | COMPLETED | 113 | — | — | Feb 1, 2016 | Jan 1, 2020 | Jan 8, 2021 | 15 | United States |
The area-under-curve of sequential C-peptide concentrations (AUC-Cpep) during the mixed-meal tolerance test (MMTT) is the gold-standard method to assess residual beta-cell (ie, insulin) secretion in type 1 diabetes.
| Arm | Type | Description |
|---|---|---|
| CLBS03 Low Dose | EXPERIMENTAL | A single infusion of CLBS03 Low Dose, a cell product comprised of autologous, ex vivo expanded regulatory T-cells resuspended in sterile USP (United States Pharmacopoeia) infusion solution. |
| CLBS03 High Dose | EXPERIMENTAL | A single infusion of CLBS03 High Dose, a cell product comprised of autologous, ex vivo expanded regulatory T-cells resuspended in sterile USP infusion solution. |
| Placebo | PLACEBO_COMPARATOR | A single infusion of placebo, consisting of the infusion solution only |
| Name | Type | Description |
|---|---|---|
| CLBS03 Low Dose | BIOLOGICAL | - |
| CLBS03 High Dose | BIOLOGICAL | - |
| Placebo | BIOLOGICAL | - |
Inclusion Criteria: * Male and females aged 8 to 17 years of age * Diagnosis of T1DM within 100 days of receipt of study drug * Positive for at least one islet cell autoantibody * Peak MMTT-stimulated C-peptide level \> 0.2 pmol/mL (at the screening visit) * Weight of ≥30 kg * Must agree to use a r...