Effectiveness and Safety of MMSCs for Enhancing Hematopoietic Recovery and Prophylaxis of Neutropenic Enterocolitis
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|ClinicalTrials.gov Identifier: NCT02145923|
Recruitment Status : Unknown
Verified June 2015 by Zarui Simavonyan, Burnasyan Federal Medical Biophysical Center.
Recruitment status was: Enrolling by invitation
First Posted : May 23, 2014
Last Update Posted : June 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Neutropenic Enterocolitis Myeloablative Chemotherapy Induced Bone Marrow Aplasia||Procedure: Peripheral blood stem cell mobilisation and collection Drug: High-dose chemotherapy Drug: Bone marrow derived allogeneic MMSCs infusion Procedure: Autologous peripheral blood stem cells infusion||Phase 1 Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||December 2016|
allogeneic MMSCs infusion
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.
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
- Number of serious adverse events (SAEs) and serious adverse reactions (SARs) [ Time Frame: 2 weeks after treatment ]
- Time of hematopoietic recovery [ Time Frame: Follow up to completion (up to 3 months after treatment) ]Monitoring of time of hematopoietic recovery assessed by complete blood count
- Neutropenic enterocolitis [ Time Frame: Follow up to completion (up to 3 months after treatment) ]Monitoring of frequency (number of participants) and severity of neutropenic enterocolitis during the study period
- Infectious complications [ Time Frame: Follow up to completion (up to 3 months after treatment) ]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.
- Transfusion needs [ Time Frame: Follow up to completion (up to 3 weeks after treatment) ]Monitoring of frequency (number of participants) of transfusion needs during neutropenic period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02145923
|State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia|
|Moscow, Russian Federation, 123182|
|Principal Investigator:||Zaryi Simavonyan, MD||Burnasyan Federal Medical Biophysical Center|
|Principal Investigator:||Ilya I Eremin, MD, PhD||Burnasyan Federal Medical Biophysical Center|