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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02652130 | Safety Follow-up of Treatment With Remestemcel-L in Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute GVHD | PHASE3 | COMPLETED | 32 | — | — | Oct 28, 2015 | Jun 15, 2018 | Mar 16, 2022 | 20 | United States |
The overall survival rate is defined as the percentage of participants alive at the given time point. OS is defined as the time to death from the start of drug therapy.
| Arm | Type | Description |
|---|---|---|
| Safety population | EXPERIMENTAL | All participants who were enrolled and had received at least 1 dose of remestemcel-L in Study MSB-GVHD001. |
| Name | Type | Description |
|---|---|---|
| Remestemcel-L | BIOLOGICAL | No intervention was given in Study MSB-GVHD002 (NCT02652130). It was a safety follow-up trial of remestemcel-L-treated participants from Study MSB-GVHD001. |
Inclusion Criteria: * Participants must have participated in MSB-GVHD001 and have received at least one infusion of remestemcel-L. * Participant or participant's authorized representative must be capable of providing written informed consent. Assent, if applicable, must also be collected when requi...