At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 32 enrolled
Drug / intervention
Remestemcel-Lbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety Follow-up Through 180 Days of Treatment With Remestemcel-L in Study MSB-GVHD001 in Pediatric Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD
In Brief
A Phase 3 clinical trial evaluating Remestemcel-L for Grade B Acute Graft Versus Host Disease and 2 related conditions. Completed, enrolled 32 participants across 20 sites.
Detailed Summary
Ongoing safety assessment follow-up to Protocol MSB-GVHD001 (NCT02336230) of remestemcel-L treatment in pediatric participants with acute graft versus host disease (aGVHD), following allogeneic hematopoietic stem cell transplant (HSCT), that have failed to respond to treatment with systemic corticosteroid therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGrade B Acute Graft Versus Host Disease, Grade C Acute Graft Versus Host Disease, Grade D Acute Graft Versus Host Disease
CountriesUnited States
CollaboratorsQuintiles, Inc.
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartOct 2015
First PostedJan 2016
Primary CompletionJun 2018
TodayJul 2026
First PostedJan 11, 2016
Enrollment StartOct 28, 2015
Primary CompletionJun 15, 2018
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 10.5 years ago
Interventions
Remestemcel-Lbiological
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.