drugset / Trial / NCT06304025

Sequential Administration of WJ-MSCs for the Treatment of GvHD Refractory to Second Line Treatment

NCT06304025 ↗

RandomizedParallel-groupDouble-blindTreatment

Summary

Hematopoietic stem cell transplantation (HSCT) is the treatment of choice for malignant hemopathies, but highlights the limitations of long-term results due to the high toxicity of the procedure and the development of Graft versus Host Disease (GVHD). Conventional treatments for GVHD have limited success rates, and some patients may be refractory to ruxolitinib, a second-line treatment option. As a result, there is a need to explore alternative immuno-modulatory therapies, such as the use of Wharton's jelly mesenchymal stem cells (WJ-MSCs). The research question aims to investigate the safety and potential benefits of sequentially infusing thawed or expanding allogeneic WJ-MSCs in the treatment of acute GVHD refractory to second-line treatment in patients from the Colombian population. This pilot clinical study is being conducted to address the unmet need for patients who develop GVHD resistant to ruxolitinib.

Timeline

Start
2024-06
Primary completion
2025-06
Completion
2025-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Wharton's Jelly Mesenchymal Stem Cells Cell therapy 1e+06 cells/kg Intravenous