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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
||A Single-arm, 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
Bone Marrow Transplant, GVHD
||Jason Law, MD
The main purpose of the study is to find out about whether the study drug, Remestemcel-L, is safe in humans and an effective product in pediatric patients with acute Graft versus Host Disease (GVHD). GVHD may occur after a bone marrow or stem cell transplant in which someone receives bone marrow tissue or cells from a donor (called an allogeneic transplant). The new, transplanted cells attack the recipient's body (the host) because they regard it as foreign.
- Grade B-D acute Graft versus Host Disease (GVHD)
- Failed to respond to steroid treatment
- Adequate kidney function
- No GVHD with only skin involvement
- No pregnant or nursing females
- No known allergy to DSMO, pig products, or cow products.
Subjects will have study visits at least once a week during the study. All study visits and study drug infusions happen in the hospital. During the initial study intervention phase, subjects will receive study drug twice a week for 4 weeks. If the study doctor determines it will help the subject, they will receive study drug once a week for another 4 weeks. If subject’s symptoms get better and then get worse, the study doctor may decide the subject should take the study drug again once a week for 4 weeks. Subjects will have a CT or MRI scan of the chest, abdomen, and pelvis before starting study drug and at the end of study visit (about 100 days after the first study drug infusion). If subjects agree, 5mL (about 1 teaspoon) of extra blood will be drawn for optional biomarker research testing.