Clinical trial · Interventional
Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Cells, in Patients With HM
Allogeneic Stem Cell Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Stem and Progenitor Cells, in Adolescent and Adult Patients With Hematological Malignancies
NCT01816230CI-TRIAL-00047864completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
A Study Evaluating the Safety and Efficacy of Transplantation of a single cord blood unit (CBU) of NiCord®, umbilical cord blood-derived Ex Vivo Expanded Stem and Progenitor Cells in Patients with Hematological Malignancies.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia (ALL) | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Myelodysplastic Syndrome (MDS) | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NiCord® | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NiCord®
- description
- NiCord® is a stem/progenitor cell based product composed of ex vivo expanded allogeneic UCB cells.
- interventionNames
- Drug: NiCord®
Primary outcomes (1)
- measure
- Engraftment
- timeFrame
- 42 days
- description
- Assess the cumulative incidence of patients with NiCord®-derived neutrophil engraftment at 42 days following transplantation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Applicable disease and eligible for myeloablative SCT * Patients must have two partially HLA-matched CBUs * Back-up stem cell source * Adequate Karnofsky Performance score or Lansky Play-Performance scale * Sufficient physiological reserves * Signed written informed consent Exclusion Criteria: * HLA-matched donor able to donate * Prior allogeneic HSCT * Other active malignancy * Active or uncontrolled infection * Active/symptoms of central nervous system (CNS) disease * Pregnancy or lactation
References
Publications (1)
- DERIVEDHorwitz ME, Wease S, Blackwell B, Valcarcel D, Frassoni F, Boelens JJ, Nierkens S, Jagasia M, Wagner JE, Kuball J, Koh LP, Majhail NS, Stiff PJ, Hanna R, Hwang WYK, Kurtzberg J, Cilloni D, Freedman LS, Montesinos P, Sanz G. Phase I/II Study of Stem-Cell Transplantation Using a Single Cord Blood Unit Expanded Ex Vivo With Nicotinamide. J Clin Oncol. 2019 Feb 10;37(5):367-374. doi: 10.1200/JCO.18.00053. Epub 2018 Dec 4. PMID 30523748