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Mesenchymal Stem Cells Infusion for aGVHD Prophylaxis Transplantation

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ClinicalTrials.gov Identifier: NCT01941394
Recruitment Status : Unknown
Verified September 2013 by Elena N.Parovichnikova, National Research Center for Hematology, Russia.
Recruitment status was:  Recruiting
First Posted : September 13, 2013
Last Update Posted : September 13, 2013
Sponsor:
Information provided by (Responsible Party):
Elena N.Parovichnikova, National Research Center for Hematology, Russia

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.

Condition or disease Intervention/treatment Phase
Graft-versus-host Disease Relapse Biological: Mesenchymal stem cells Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : October 2007
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014


Arm Intervention/treatment
Experimental: With MSC
infusion of Mesenchymal stem cells at dose 1 mln cells per kg
Biological: Mesenchymal stem cells
Mesenchymal stem cells infusion
Other Name: Mesenchymal stem cells infusion

No Intervention: Without MSC
Without MSC infusion



Primary Outcome Measures :
  1. GVHD [ Time Frame: Every 30 day for 1 year after BMT ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Every 30 day for 1 year after BMT ]
  2. Relapse-free survival [ Time Frame: Every 30 day for 1 year after BMT ]
  3. Infection rate [ Time Frame: Every 30 day for 1 year after BMT ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT01941394


Contacts
Contact: Elena Parovichnikova, Prof MD PhD +79161252623 elenap@blood.ru
Contact: Larisa Kuzmina, MD PhD +79161487131 kuzlara@rambler.ru

Locations
Russian Federation
BMT department Recruiting
Moscow, Russian Federation
Contact: Elena Parovichnikova, Prof MD PhD    +79161487131    kuzlara@rambler.ru   
Principal Investigator: Elena Parovichnikova         
Sponsors and Collaborators
National Research Center for Hematology, Russia
Investigators
Principal Investigator: Elena Parovichnikova, Prof MD PhD National Research Center for Hematology

Publications of Results:
Responsible Party: Elena N.Parovichnikova, Head of BMT department, National Research Center for Hematology, Russia
ClinicalTrials.gov Identifier: NCT01941394     History of Changes
Other Study ID Numbers: NRCH-MSC
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: September 13, 2013
Last Verified: September 2013

Keywords provided by Elena N.Parovichnikova, National Research Center for Hematology, Russia:
GVHD
Relapse
Overall Survival

Additional relevant MeSH terms:
Recurrence
Graft vs Host Disease
Disease Attributes
Pathologic Processes
Immune System Diseases