Clinical trial · Interventional
Allogenic Transplantation of Ex-vivo Expanded Cord Blood (CB)
Allogenic Transplantation of Ex-vivo Expanded CB Progenitors for Haematological Disorders
NCT01235468CI-TRIAL-00020041withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): loss of support
Summary
Brief summary (as posted)
The aim of this study is to evaluate the safety profile and tolerability of infusion of cord blood cells expanded in the lab and to evaluated whether through the infusion of expanded cells it is possible to expedite engraftment time after transplantation.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | PROBABILISTIC | 0.70 |
| Stem Cell Transplantation | — | UNRESOLVED | — |
| Umbilical Cord Blood | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ex vivo expansion | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CB expnasion
- description
- ex-vivo expansion of cord blood for transplantation
- interventionNames
- Biological: ex vivo expansion
Primary outcomes (4)
- measure
- Safety
- timeFrame
- 1 month
- description
- Number of patients with adverse events during infusion
- measure
- engraftment
- timeFrame
- 3 months
- description
- Time to engraftment
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * age \> 18 years * hematological malignancy * standard indication for allogeneic transplantation * expected survival time over 12 weeks * no related or unrelated donor * availability of a cord blood unit of compatible placental blood cryopreserved in at least 2 different bags; one of the two units should have a cellular content at least equal to the minimum dose of 2 x 107 nucleated cells per kilogram of body weight Exclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status \>2 * Prior allogeneic transplantation * Pregnant or nursing women * Positive serology for hepatitis B or C * HIV positive * Left ventricular ejection fraction \< 50% * DLCO \< 50% * Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study * Treatment with other investigational drugs within 4 weeks of enrolling in this protocol
References
Publications (0)
Data not yet available
No reference posted for this study.