Study of Amimestrocel Injection to Prevent Severe Mouth and Gut Sores in Adults Undergoing Stem Cell Transplant with TBI or Melphalan Conditioning

What this Trial Is About

The trial investigates whether a single intravenous infusion of Amimestrocel injection, a cell therapy made from human umbilical cord mesenchymal stem cells, can help reduce severe mouth sores called oral mucositis in adults undergoing myeloablative allogeneic hematopoietic stem cell transplantation HSCT. This painful side effect commonly occurs due to strong chemotherapy regimens containing total body irradiation TBI andor melphalan. The study is a Phase 2, single-center, open-label exploratory trial involving about 22 adult patients aged 18 to 65 years. Participants will receive a single fixed dose of Amimestrocel injection 6.0 107 cells in 12 mL intravenously within 24 to 48 hours after the last dose of cyclophosphamide, which is part of the standard conditioning regimen, and before the stem cell infusion Day 0. All patients will also undergo standard myeloablative conditioning containing TBI andor melphalan, followed by allogeneic stem cell transplantation and standard supportive care. During the study, patients will be closely monitored daily for the presence and severity of oral mucositis and pain for 28 days after transplant. Researchers will assess pain levels, opioid use, diarrhea, and time until blood counts recover. Safety will be followed for 100 days post-transplant, including adverse events and serious adverse events. The main outcome is the incidence of severe Grade 3-4 oral mucositis within 28 days after transplant.

Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients