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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00136903 | Safety and Efficacy Study of Adult Human Mesenchymal Stem Cells to Treat Acute Graft Versus Host Disease (GVHD) | PHASE2 | COMPLETED | 32 | — | — | Apr 27, 2005 | Jul 14, 2008 | Jan 31, 2022 | 9 | United States |
| Arm | Type | Description |
|---|---|---|
| Prochymal® - 2 Million cells/kg | ACTIVE_COMPARATOR | Participants will receive Prochymal® consisting of 2 million hMSCs/kg actual body weight, intravenously (IV) on Days 1 and 4 along with daily standard of care which includes methylprednisolone 2 milligrams (mg)/kg IV or prednisone 2.5 mg/kg orally. Participants will also continue cyclosporine, tacrolimus, and/or mycophenolate mofetil (MMF) at full therapeutic doses. |
| Prochymal® - 8 Million cells/kg | ACTIVE_COMPARATOR | Participants will receive Prochymal® consisting of 8 million hMSCs/kg actual body weight IV on Days 1 and 4 along with daily standard of care which includes methylprednisolone 2 mg/kg IV or prednisone 2.5 mg/kg orally. Participants will also continue cyclosporine, tacrolimus, and/or mycophenolate mofetil (MMF) at full therapeutic doses. |
| Name | Type | Description |
|---|---|---|
| Prochymal® - 2 Million cells/kg | DRUG | 2 million hMSCs/kg actual body weight, IV on study Days 1 and 4 |
| Prochymal®- 8 Million cells/kg | DRUG | 8 million hMSCs/kg actual body weight IV on study Days 1 and 4 |
| Methylprednisolone | DRUG | Methylprednisolone 2 mg/kg administered intravenously. |
| Prednisone | DRUG | Prednisone 2.5 mg/kg administered orally. |
| Cyclosporine | DRUG | Administered as prescribed by the caregiver. |
| Tacrolimus | DRUG | Administered as prescribed by the caregiver. |
| Mycophenolate Mofetil | DRUG | Administered as prescribed by the caregiver. |
Protocol 260 Inclusion Criteria: * Participant must be 18 to 70 years of age inclusive. * If female and of child-bearing age, participant must be non-pregnant, not breast feeding, and use adequate contraception. Males must use adequate contraception. * Participant must have newly diagnosed, Grade I...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 11 | PHASE3 | INCA034176, Tacrolimus, Methotrexate, Ruxolitinib, Cyclophosphamide |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE3 | Belumosudil, Prednisone, Prednisolone |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Ibrutinib |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Theriva Biologics, Inc. | TOVX | 1 | PHASE1 | Undisclosed |
| Novartis AG Sponsored ADR | NVS | 1 | — | Undisclosed |