NCT03389919

Intraosseous Administration of Mesenchymal Stromal Cells for Patients With Graft Failure After Allo-HSCT

EFFECTIVENESS AND SAFETY OF INTRAOSSEOUS ADMINISTRATION OF MESENCHYMAL STORMAL CELLS FOR PRIMARY GRAFT FAILURE AFTER ALLOGENEIC STEM CELL TRANSPLANTATION

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: National Research Center for Hematology, Russia · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multipotent mesenchymal stromal cells (MSCs) participate in the formation of bone marrow niches for hematopoietic stem cells. Donor MSCs can serve as a source of recovery for niches in patients with graft failure (GF) after allogeneic bone marrow (BM) transplantation. Since only few MSCs reach the BM after intravenous injection, MSCs were implanted into the iliac spine. Preliminary results suggest that MSCs participate in the restoration of niches for donor hematopoietic cells or have an immunomodulatory effect, preventing repeated rejection of the graft. Perhaps intraosseous implantation of MSCs contributes to the success of the second transplantation of hematopoietic stem cells and patient survival.

Conditions

• Mesenchymal Stem Cell Transplantation

Interventions

Type	Name	Description
BIOLOGICAL	MSC administration (intraosseal)	MSCs will be administered under local anesthesia to the iliac crests after receiving informed consent from the patient.

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-12-31
• Completion: 2022-12-31
• First posted: 2018-01-04
• Last updated: 2018-01-04

Locations

1 site across 1 country: Russia