Phase 2
Completed N=36
Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Cells, in Patients With HM
hematological malignancies · leukemia · Myelodysplastic Syndrome (MDS)
Source: ClinicalTrials.gov NCT01816230 ↗
Enrolled (actual)
36
Serious AEs
94.4%
Results posted
Sep 2020
Primary outcomePrimary: Engraftment — 94 percentage of patients
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Engraftment |
94 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01816230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.