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

Phase 3

• Conditions: Mesenchymal Stem Cell Transplantation

• Registration Number: NCT03389919
• Lead Sponsor: National Research Center for Hematology, Russia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Status Verified: 2017-12
• Study First Submitted: 2017-12-27
• Study First Submitted QC: 2017-12-27
• Last Update Submitted: 2017-12-27
• Study First Posted: 2018-01-04
• Last Update Posted: 2018-01-04
• Primary Completion: 2020-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• All patients with primary graft failure after allo-HSCT
• Available MSC for this patient

Exclusion Criteria

• N/A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Engraftment	28-day	Engraftment

Trial Locations

Locations (1)

BMT department; 🇷🇺 Moscow, Russian Federation