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Safety Follow-up of Treatment With Remestemcel-L in Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute GVHD

NCT02652130 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-03-16

Study results available
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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.

Conditions

  • Grade B Acute Graft Versus Host Disease
  • Grade C Acute Graft Versus Host Disease
  • Grade D Acute Graft Versus Host Disease

Interventions

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.

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Mesoblast, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher James · Mesoblast, Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-28
Primary Completion
2018-06-15
Completion
2018-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02652130 on ClinicalTrials.gov