Neutropenic Enterocolitis Clinical Trial
Official title:
Effectiveness and Safety of Intravenous Infusion of Bone Marrow Derived Allogeneic Multipotent Mesenchymal Stromal Cells for Enhancing Hematopoietic Recovery and Prophylaxis of Neutropenic Enterocolitis in Hematological Patients With Aplasia After High-dose Chemotherapy.
Subjects will undergo peripheral blood stem cell mobilisation and collection with subsequent high-dose chemotherapy. After finalization of high-dose chemotherapy subjects will receive bone marrow derived allogeneic multipotent mesenchymal stromal cells intravenous infusion two hours prior to autologous peripheral blood cells infusion. This is a single arm study with no control. All patients receive cell therapy.
Patients with verified diagnosis Hodgkin's lymphoma or non-Hodgkin's lymphoma will undergo
peripheral blood stem cell mobilisation and collection (chemotherapy + G-CSF or
G-CSF+Plerixafor).
After that high-dose chemotherapy will be performed according to protocols ICE and BEAM
(standard scheme).
Patient will receive bone marrow derived allogeneic multipotent mesenchymal stromal cells
infusion 48 hours after last administration of cytotoxic agent . Number of cells calculated
according to patient's body weight (1,5-2,0 mln of cells/kg), time of infusion - 30 minutes.
Two hours later patient will receive autologous peripheral blood cells infusion.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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