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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01941394
Other study ID # NRCH-MSC
Secondary ID
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


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
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