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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
16
High-dose chemotherapy will be performed according to protocols ICE and BEAM (standard scheme)
State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia
Moscow, Russia
Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
Time frame: 2 weeks after treatment
Time of hematopoietic recovery
Monitoring of time of hematopoietic recovery assessed by complete blood count
Time frame: Follow up to completion (up to 3 months after treatment)
Neutropenic enterocolitis
Monitoring of frequency (number of participants) and severity of neutropenic enterocolitis during the study period
Time frame: Follow up to completion (up to 3 months after treatment)
Infectious complications
Monitoring of frequency and severity of infectious complications during the study period. Frequency of infectious complications will be represented in number of infections verified by clinical, instrumental examination and/or laboratory methods.
Time frame: Follow up to completion (up to 3 months after treatment)
Transfusion needs
Monitoring of frequency (number of participants) of transfusion needs during neutropenic period
Time frame: Follow up to completion (up to 3 weeks after treatment)
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