Mesenchymal Stem Cells Infusion for aGVHD Prophylaxis Transplantation

September 12, 2013 updated by: Elena N.Parovichnikova, National Research Center for Hematology, Russia

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Recruiting
        • BMT department
        • Contact:
        • Principal Investigator:
          • Elena Parovichnikova

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • allogenic BMT from related or unrelated donor

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Mesenchymal stem cells infusion
No Intervention: Without MSC
Without MSC infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
GVHD
Time Frame: Every 30 day for 1 year after BMT
Every 30 day for 1 year after BMT

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Every 30 day for 1 year after BMT
Every 30 day for 1 year after BMT
Relapse-free survival
Time Frame: Every 30 day for 1 year after BMT
Every 30 day for 1 year after BMT
Infection rate
Time Frame: Every 30 day for 1 year after BMT
Every 30 day for 1 year after BMT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Center for Hematology, Russia

Investigators

  • Principal Investigator: Elena Parovichnikova, Prof MD PhD, National Research Center for Hematology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

August 30, 2013

First Submitted That Met QC Criteria

September 12, 2013

First Posted (Estimate)

September 13, 2013

Study Record Updates

Last Update Posted (Estimate)

September 13, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRCH-MSC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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