Clinical trial · Interventional
Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cord blood (CB) from an unrelated donor is increasingly used an alternative source of hematopoietic stem cells for adults with hematologic malignancies who lack an HLA-matched donor. However, the utilization of single-unit CB for transplantation of adult patients has been impeded by the low number of nucleated cells available from individual CB units. Direct intrabone CB injection (IBCBi) has been recently investigated as a solution to cell dose problem in adults, with the aims of minimizing non-specific loss of progenitors. We set up a phase I-II study to assess the safety and efficacy of CB transplantation by IBCBi in adult patients with advanced or high-risk hematological malignancies
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Haematological Malignancies | — | UNRESOLVED | — |
| High Risk Haematological Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intrabone Allogeneic Transplant | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Patients with high risk haematological malignancies
- interventionNames
- Procedure: Intrabone Allogeneic Transplant
Primary outcomes (1)
- measure
- Time to neutrophil recovery
- timeFrame
- 28 days after transplantation
Secondary outcomes (4)
- measure
- Incidence of platelet engraftment
- timeFrame
- 100 days after transplantation
- measure
- Acute graft versus host disease
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced or High Risk Haematological Malignancies * Age 18-65 years * no suitable unrelated HLA-matched donors identified in a clinically useful time-frame * Informed consent Exclusion Criteria: * Active infectious disease at inclusion * HIV- positivity or active hepatitis infection * Impaired liver function (Bilirubin \> upper normal limit; Transaminases \> 3.0 x upper normal limit) at inclusion * Impaired renal function (Creatinine-clearance \<60 ml/min; Serum Creatinine \>1.5 x upper normal limit) at inclusion * Psychiatric diseases or conditions that might impair the ability to give informed consent
References
Publications (2)
- BACKGROUNDFrassoni F, Gualandi F, Podesta M, Raiola AM, Ibatici A, Piaggio G, Sessarego M, Sessarego N, Gobbi M, Sacchi N, Labopin M, Bacigalupo A. Direct intrabone transplant of unrelated cord-blood cells in acute leukaemia: a phase I/II study. Lancet Oncol. 2008 Sep;9(9):831-9. doi: 10.1016/S1470-2045(08)70180-3. Epub 2008 Aug 8. PMID 18693069
- BACKGROUNDPage KM, Zhang L, Mendizabal A, Wease S, Carter S, Gentry T, Balber AE, Kurtzberg J. Total colony-forming units are a strong, independent predictor of neutrophil and platelet engraftment after unrelated umbilical cord blood transplantation: a single-center analysis of 435 cord blood transplants. Biol Blood Marrow Transplant. 2011 Sep;17(9):1362-74. doi: 10.1016/j.bbmt.2011.01.011. Epub 2011 Jan 28. PMID 21277377