Mesenchymal Stem Cells Infusion for aGVHD Prophylaxis Transplantation

Relapse Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01941394
• Other study ID #: NRCH-MSC
• Status: Recruiting
• Phase: Phase 2
• First received: August 30, 2013
• Last updated: September 12, 2013
• Start date: October 2007
• Est. completion date: October 2014

Study information

• Verified date: September 2013
• Source: National Research Center for Hematology, Russia
• Contact: Elena Parovichnikova, Prof MD PhD
• Phone: +79161252623
• Email: elenap[@]blood.ru
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-versus-host Disease
• Relapse

Intervention

Biological:
• Mesenchymal stem cells
Mesenchymal stem cells infusion

Locations

Country	Name	City	State
Russian Federation	BMT department	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
National Research Center for Hematology, Russia

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

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 Dise — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GVHD		Every 30 day for 1 year after BMT	Yes
Secondary	Overall survival		Every 30 day for 1 year after BMT	Yes
Secondary	Relapse-free survival		Every 30 day for 1 year after BMT	Yes
Secondary	Infection rate		Every 30 day for 1 year after BMT	Yes