Overview

A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD

Status:
Completed

Trial end date:
2018-04-09

Target enrollment:

Participant gender:

Summary

The study plans to treat at least 60 pediatric subjects, male and female, between the ages of 2 months and 17 years inclusive with acute Graft versus Host Disease (aGVHD) following allogeneic hematopoietic stem cell transplant (HSCT) that has failed to respond to treatment with systemic corticosteroid therapy. Subjects may have Grades C and D aGVHD involving the skin, liver and/or gastrointestinal (GI) tract or Grade B aGVHD involving the liver and/or GI tract, with or without concomitant skin disease.

Phase:

Phase 3

Details

Lead Sponsor:

Mesoblast International Sàrl
Mesoblast, Inc.

Collaborator:

Quintiles, Inc.

Treatments:

Remestemcel-l