Trials / Completed
CompletedNCT02652130
Safety Follow-up of Treatment With Remestemcel-L in Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute GVHD
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Mesoblast, Inc. · Industry
- Sex
- All
- Age
- 2 Months – 17 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is a safety follow-up study through 180 days of remestemcel-L treatment in participants who took part in MSB-GVHD001. This study will also explore duration of response over time. Participants who took part in in MSB-GVHD001 and received at least one dose of remestemcel-L as outlined in that protocol will be evaluated at baseline (Day 100) and at Days 120, 140, 160 and 180 for safety endpoints. Participants who took part in Protocol MSB-GVHD001 and received the first 8 doses of remestemcel-L as outlined in that protocol will be evaluated at baseline (Day 100) and at Days 120, 140, 160 and 180 after initial remestemcel-L infusion for evidence of duration of response over time.
Conditions
- Grade B Acute Graft Versus Host Disease
- Grade C Acute Graft Versus Host Disease
- Grade D Acute Graft Versus Host Disease
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Remestemcel-L | 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. |
Timeline
- Start date
- 2015-10-28
- Primary completion
- 2018-06-15
- Completion
- 2018-06-15
- First posted
- 2016-01-11
- Last updated
- 2022-03-16
- Results posted
- 2022-03-16
Locations
20 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02652130. Inclusion in this directory is not an endorsement.