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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01843387 | Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy | PHASE1 | COMPLETED | 30 | — | — | Jul 1, 2013 | Sep 1, 2015 | Oct 14, 2016 | 2 | Australia |
Outcomes include the following safety parameters: * Number of and percent of subject with adverse events and serious adverse events * Clinically significant values and shifts from baseline in vital signs, physical examinations and electrocardiograms * Clinical laboratory tests (hematology, chemistry and urinalysis, flow cytometry with Class I and Class II PRA % with specificity)
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Mesenchymal Precursor Cells (MPCs) - Dose 1 or Placebo |
| Cohort 2 | EXPERIMENTAL | Mesenchymal Precursor Cells (MPCs) - Dose 2 or Placebo |
| Name | Type | Description |
|---|---|---|
| Mesenchymal Precursor Cells (MPCs) | BIOLOGICAL | Single Intravenous Infusion of MPCs Dose 1 or Placebo |
Inclusion Criteria: * Men and women who are ≥ 50 and ≤ 85 years old * Subjects diagnosed with type 2 diabetes at least 2 years prior to Screening * Subjects with diabetic nephropathy and CKD stage 3b-4 * Albumin-to-creatinine ratio (ACR) from a spot urine sample \>30 and \< 3000 mg/g at Screening *...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | ALN-ANG3, Evinacumab |
| DexCom, Inc. | DXCM | 1 | PHASE3 | Sotagliflozin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | Atrasentan |
| ProKidney Corp. Class A | PROK | 2 | — | Renal Autologous Cell Therapy |