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NCT01816230 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), sponsored by Gamida Cell.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target
15
Study locations

NCT01816230 is a Phase 1 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) that has completed, run by Gamida Cell. The registered enrollment target is 36 participants, below the 144-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (75% lower). The trial reports 15 study locations across 9 states.

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The verdict

NCT01816230, a Phase 1 study of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), has completed, sponsored by Gamida Cell.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target
15
Study locations

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.

Conditions Studied

Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome (MDS) Acute Lymphoblastic Leukemia (ALL) 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

8 total trials

Interested in This Trial?

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, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 144-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (75% lower). The listed sponsor is Gamida Cell, which has 8 total studies on file at ClinicalTrials.gov.

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.

NCT01816230 reports 15 study locations spanning 9 distinct geographic areas - top geographies include Other, California, Illinois.

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), Acute Lymphoblastic Leukemia (ALL), Hematological Malignancies.

What interventions are being tested in trial NCT01816230?

The interventions under investigation include: NiCord® (DRUG).

Who is sponsoring clinical trial NCT01816230?

This trial is sponsored by Gamida Cell, which has 8 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.