Mesenchymal Stem Cells Infusion for aGVHD Prophylaxis Transplantation

National Research Center for Hematology, Russia

Status and phase: Unknown; Phase 2

Conditions: Graft-versus-host Disease; Relapse

Treatments: Biological: Mesenchymal stem cells

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01941394

NRCH-MSC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• allogenic BMT from related or unrelated donor

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

With MSC

Experimental group

Description:

infusion of Mesenchymal stem cells at dose 1 mln cells per kg

Treatment:

Biological: Mesenchymal stem cells

Without MSC

No Intervention group

Description:

Without MSC infusion