Mesenchymal Stem Cells Infusion for aGVHD Prophylaxis Transplantation

Phase 2

• Conditions: Graft-versus-host Disease; Relapse
• Interventions: Biological: Mesenchymal stem cells

• Registration Number: NCT01941394
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-10
• Study First Submitted: 2013-08-30
• Status Verified: 2013-09
• Study First Submitted QC: 2013-09-12
• Last Update Submitted: 2013-09-12
• Study First Posted: 2013-09-13
• Last Update Posted: 2013-09-13
• Primary Completion: 2014-10
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With MSC	Mesenchymal stem cells	infusion of Mesenchymal stem cells at dose 1 mln cells per kg

Primary Outcome Measures

Name	Time	Method
GVHD	Every 30 day for 1 year after BMT

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

BMT department; 🇷🇺 Moscow, Russian Federation