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Pilot Study Evaluating Safety & Efficacy of DCBT: NiCord® & UNM CBU to Patients With Hematological Malignancies

NCT01221857 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-08-03

Study results available
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Summary

Pilot Study Evaluating the Safety and Efficacy of a Co-Transplantation of NiCord®, a UCB-derived ex Vivo Expanded Population of Stem and Progenitor Cells with a Second, Unmanipulated CBU in Patients with Hematological Malignancies

Conditions

  • Acute Lymphoblastic Leukemia (ALL)
  • Acute Myelogenous Leukemia (AML)
  • Myelodysplastic Syndrome (MDS)
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Disease

Interventions

DRUG

NiCord®

NiCord® is a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells.

Sponsors & Collaborators

  • Gamida Cell ltd

    lead INDUSTRY

Principal Investigators

  • David Snyder, PhD · Gamida Cell ltd

  • Joanne Kurtzberg, MD · Duke University

  • Mitchell Horwitz, MD · Duke University

  • Patrick Stiff, MD · Loyola University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-09-30
Completion
2013-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01221857 on ClinicalTrials.gov