Phase 2 N=36 Treatment

Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Cells, in Patients With HM

Hematological Malignancies · Acute Lymphoblastic Leukemia (ALL) · Acute Myeloid Leukemia (AML) · Myelodysplastic Syndrome (MDS)

Bottom Line

View on ClinicalTrials.gov: NCT01816230 ↗

Enrolled (actual)

Serious AEs

94.4%

Results posted

Sep 2020

Primary outcome: Primary: Engraftment — 94 percentage of patients

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: NiCord® (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Gamida Cell ltd
Primary completion: Jun 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Engraftment	94	—

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.

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

View full record on ClinicalTrials.gov →

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.