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COMPLETED Phase 1

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

NCT01816230 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG NiCord®

Study Locations (15)

Other

  • Children Hospital Gaslini Scientific Institute — Genoa
  • University of Turin — Turin
  • University Medical Center Utrecht — Utrecht
  • National University Cancer Institute — Singapore
  • Singapore General Hospital — Singapore
  • University Hospital Vall d´Hebron — Barcelona
  • Hospital Universitario La Fe — Valencia

California

  • Cedars-Sinai Medical Center — Los Angeles

Illinois

  • Loyola University, Cardinal Bernardin Cancer Center — Maywood

Minnesota

  • University of Minnesota — Minneapolis

New York

  • Steven and Alexandra Cohen Children's Medical Center — New York

North Carolina

  • Duke University Medical Center — Durham

Ohio

  • Cleveland Clinic — Cleveland

Oregon

  • Oregon Health & Science University — Portland

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2013-04
Est. Completion 2018-06
Phase Phase 1

Sponsor

Gamida Cell

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01816230

The ClinicalTrials.gov registry entry for NCT01816230 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gamida Cell, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Acute Myeloid Leukemia (AML) appearing as the primary indexed condition, and to 1 intervention — of which NiCord® is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01816230 reports 15 study locations spanning 9 distinct geographic areas — top geographies include Other, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01816230 about?

NCT01816230 is a clinical study titled "Transplantation of NiCord®, Umbilical Cord Blood-derived Ex Vivo Expanded Cells, in Patients With HM". 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.

What is the current status of trial NCT01816230?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2013-04. Estimated completion is 2018-06.

What conditions does trial NCT01816230 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Hematological Malignancies, Acute Lymphoblastic Leukemia (ALL). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01816230?

The interventions under investigation include: NiCord® (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01816230?

This trial is sponsored by Gamida Cell, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01816230 being conducted?

This trial has 15 study locations across California, Illinois, Minnesota, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial