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NCT03389919
Intraosseous Administration of Mesenchymal Stromal Cells for Patients With Graft Failure After Allo-HSCT
Phase 3 trial testing MSC administration (intraosseal) in Mesenchymal Stem Cell Transplantation in 20 participants. Status unknown.
31 December 2020
Quick facts
| Lead sponsor | National Research Center for Hematology, Russia |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 January 2017 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 December 2022 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- MSC administration (intraosseal) — full drug profile →
Conditions studied
- Mesenchymal Stem Cell Transplantation — all drugs for Mesenchymal Stem Cell Transplantation →
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):
-
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 -
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 -
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:
- PubMed search for NCT03389919
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03389919 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Research Center for Hematology, Russia
- Last refreshed: 4 January 2018
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.
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