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Mesenchymal Stem Cells Infusion for aGVHD Prophylaxis Transplantation

Primary Purpose

Graft-versus-host Disease, Relapse

Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Mesenchymal stem cells
Sponsored by
National Research Center for Hematology, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Graft-versus-host Disease focused on measuring GVHD, Relapse, Overall Survival

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • allogenic BMT from related or unrelated donor

Exclusion Criteria:

  • Severe infection
  • Relapse
  • admission to ICU
  • refusal of research
  • patients with graft failure

Sites / Locations

  • BMT departmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

With MSC

Without MSC

Arm Description

infusion of Mesenchymal stem cells at dose 1 mln cells per kg

Without MSC infusion

Outcomes

Primary Outcome Measures

GVHD

Secondary Outcome Measures

Overall survival
Relapse-free survival
Infection rate

Full Information

First Posted
August 30, 2013
Last Updated
September 12, 2013
Sponsor
National Research Center for Hematology, Russia
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1. Study Identification

Unique Protocol Identification Number
NCT01941394
Brief Title
Mesenchymal Stem Cells Infusion for aGVHD Prophylaxis Transplantation
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Center for Hematology, Russia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Infusion of mesenchymal stem cells at day of recovery after BMT for patients with AL, AA and MM for acute GVHD prophylaxis and treatment. Infusion at dose 1 cells mln/kg at day of white blood cells recovery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft-versus-host Disease, Relapse
Keywords
GVHD, Relapse, Overall Survival

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
With MSC
Arm Type
Experimental
Arm Description
infusion of Mesenchymal stem cells at dose 1 mln cells per kg
Arm Title
Without MSC
Arm Type
No Intervention
Arm Description
Without MSC infusion
Intervention Type
Biological
Intervention Name(s)
Mesenchymal stem cells
Other Intervention Name(s)
Mesenchymal stem cells infusion
Intervention Description
Mesenchymal stem cells infusion
Primary Outcome Measure Information:
Title
GVHD
Time Frame
Every 30 day for 1 year after BMT
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
Every 30 day for 1 year after BMT
Title
Relapse-free survival
Time Frame
Every 30 day for 1 year after BMT
Title
Infection rate
Time Frame
Every 30 day for 1 year after BMT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: allogenic BMT from related or unrelated donor Exclusion Criteria: Severe infection Relapse admission to ICU refusal of research patients with graft failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elena Parovichnikova, Prof MD PhD
Phone
+79161252623
Email
elenap@blood.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Larisa Kuzmina, MD PhD
Phone
+79161487131
Email
kuzlara@rambler.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Parovichnikova, Prof MD PhD
Organizational Affiliation
National Research Center for Hematology
Official's Role
Principal Investigator
Facility Information:
Facility Name
BMT department
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Parovichnikova, Prof MD PhD
Phone
+79161487131
Email
kuzlara@rambler.ru
First Name & Middle Initial & Last Name & Degree
Elena Parovichnikova

12. IPD Sharing Statement

Citations:
PubMed Identifier
22242033
Citation
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.
Results Reference
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Mesenchymal Stem Cells Infusion for aGVHD Prophylaxis Transplantation

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