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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04990427 | CLBS201 in Patients with Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM) | PHASE1 | COMPLETED | 6 | — | — | Jan 10, 2022 | Jan 26, 2023 | Oct 9, 2024 | 1 | United States |
Proportion of patients with a treatment-emergent serious adverse event
| Arm | Type | Description |
|---|---|---|
| CLBS201 | EXPERIMENTAL | CLBS201 will be administered in an open-label fashion via intra-renal-arterial infusion in 6 subjects followed by 6 months of observation. |
| Name | Type | Description |
|---|---|---|
| CLBS201 | DRUG | 1 x 10\^6 to 300 x 10\^6 autologous CD34+ cells |
Inclusion Criteria: 1. Adults aged 18 to 75 years, inclusive 2. Documented diagnosis of type 2 diabetes 3. eGFR of 30 to \<45 mL/min/1.73m at the screening visit. 4. UACR 300 mg/g to ≤ 5000 mg/g Exclusion Criteria: 1. Hemoglobin \< 10 g/dL 2. Hemoglobin A1c ≥8% at the time of screening 3. Acute k...