Last reviewed · How we verify

NCT03389919

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

Status unknown Phase 3 Last updated 4 January 2018
What this trial tests

Phase 3 trial testing MSC administration (intraosseal) in Mesenchymal Stem Cell Transplantation in 20 participants. Status unknown.

Timeline
1 January 2017
Primary endpoint
31 December 2020
31 December 2022

Quick facts

Lead sponsorNational Research Center for Hematology, Russia
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment20
Start date1 January 2017
Primary completion31 December 2020
Estimated completion31 December 2022
Sites1 location across Russia

Drugs / interventions tested

Conditions studied

Sponsor

National Research Center for Hematology, Russia — full company profile →

Who can join

18 and older, any sex, with Mesenchymal Stem Cell Transplantation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Therapeutic Mesenchymal Stem/Stromal Cells: Value, Challenges and Optimization.
    Najar M, Melki R, Khalife F, Lagneaux L, et al · · 2021 · cited 64× · PMID 35096805 · DOI 10.3389/fcell.2021.716853
  2. Promising role for mesenchymal stromal cells in coronavirus infectious disease-19 (COVID-19)-related severe acute respiratory syndrome?
    Hamdan H, Hashmi SK, Lazarus H, Gale RP, et al · · 2021 · cited 11× · PMID 32854985 · DOI 10.1016/j.blre.2020.100742
  3. Recovery of Donor Hematopoiesis after Graft Failure and Second Hematopoietic Stem Cell Transplantation with Intraosseous Administration of Mesenchymal Stromal Cells.
    Petinati N, Drize N, Sats N, Risinskaya N, et al · · 2018 · cited 9× · PMID 29760731 · DOI 10.1155/2018/6495018

Verify or expand the search:

Other National Research Center for Hematology, Russia trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03389919.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing