Mesenchymal Stem Cells Infusion for aGVHD Prophylaxis Transplantation
Pilot Study for Safety and Effectiveness Assessment of Bone Marrow Mesenchymal Stem Cell Infusion for Acute Graft-versus-host Disease Prophylaxis and Treatment After Allogenic Bone Marrow Transplantation
1 other identifier
interventional
70
1 country
1
Brief Summary
Infusion of Mesenchymal Stem Cell (MSC) at day of recovery after bone marrow transplant (BMT) for patients with AL, AA and MM for acute Graft-versus-host Disease (GVHD) prophylaxis and treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2007
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 30, 2013
CompletedFirst Posted
Study publicly available on registry
September 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedSeptember 13, 2013
September 1, 2013
7 years
August 30, 2013
September 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
GVHD
Every 30 day for 1 year after BMT
Secondary Outcomes (3)
Overall survival
Every 30 day for 1 year after BMT
Relapse-free survival
Every 30 day for 1 year after BMT
Infection rate
Every 30 day for 1 year after BMT
Study Arms (2)
With MSC
EXPERIMENTALinfusion of Mesenchymal stem cells at dose 1 mln cells per kg
Without MSC
NO INTERVENTIONWithout MSC infusion
Interventions
Mesenchymal stem cells infusion
Eligibility Criteria
You may qualify if:
- allogenic BMT from related or unrelated donor
You may not qualify if:
- Severe infection
- Relapse
- admission to ICU
- refusal of research
- patients with graft failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BMT department
Moscow, Russia
Related Publications (2)
Kuzmina LA, Petinati NA, Parovichnikova EN, Lubimova LS, Gribanova EO, Gaponova TV, Shipounova IN, Zhironkina OA, Bigildeev AE, Svinareva DA, Drize NJ, Savchenko VG. Multipotent Mesenchymal Stromal Cells for the Prophylaxis of Acute Graft-versus-Host Disease-A Phase II Study. Stem Cells Int. 2012;2012:968213. doi: 10.1155/2012/968213. Epub 2011 Dec 25.
PMID: 22242033RESULTPetinati N, Davydova Y, Nikiforova K, Bigildeev A, Belyavsky A, Arapidi G, Drize N, Kuzmina L, Parovichnikova E, Savchenko V. T Cell and Cytokine Dynamics in the Blood of Patients after Hematopoietic Stem Cell Transplantation and Multipotent Mesenchymal Stromal Cell Administration. Transplant Cell Ther. 2023 Feb;29(2):109.e1-109.e10. doi: 10.1016/j.jtct.2022.10.030. Epub 2022 Nov 11.
PMID: 36372356DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elena Parovichnikova, Prof MD PhD
National Research Center for Hematology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of BMT department
Study Record Dates
First Submitted
August 30, 2013
First Posted
September 13, 2013
Study Start
October 1, 2007
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
September 13, 2013
Record last verified: 2013-09