NCT02145923

Effectiveness and Safety of MMSCs for Enhancing Hematopoietic Recovery and Prophylaxis of Neutropenic Enterocolitis

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.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Burnasyan Federal Medical Biophysical Center · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Neutropenic Enterocolitis
• Myeloablative Chemotherapy Induced Bone Marrow Aplasia

Interventions

Type	Name	Description
PROCEDURE	Peripheral blood stem cell mobilisation and collection
DRUG	High-dose chemotherapy	High-dose chemotherapy will be performed according to protocols ICE and BEAM (standard scheme)
DRUG	Bone marrow derived allogeneic MMSCs infusion
PROCEDURE	Autologous peripheral blood stem cells infusion

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-06-01
• Completion: 2016-12-01
• First posted: 2014-05-23
• Last updated: 2015-06-10

Locations

1 site across 1 country: Russia