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Umbilical Cord Transplantation for the Elderly Population

NCT01484470 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-08-21

No results posted yet for this study

Summary

While cord blood transplants have been performed safely in elderly patients, many still relapse. The investigators propose to intensify the preparative regimen for this patient group in an attempt to decrease relapses, and combine this with an ex vivo expanded Umbilical Cord Blood (UCB) unit.

Conditions

Interventions

BIOLOGICAL

StemEx

For patients allocated to StemEx® arm: * Day -20: Start small (or equal) portion expansion at processing site. (II) Conditioning Phase * Day -6 to -1: Subject receives a RIC regimen containing Fludarabine, Cyclophosphamide and Total Body Irradiation (TBI) (III) Transplantation and Follow-up Phase * Day 0: CBU unmanipulated portion transplantation (for StemEx® arm) or unmanipulated CBU transplantation. * Day 1: StemEx® transplantation. * Day 2 to 3 years: Post transplant follow-up.

Sponsors & Collaborators

  • Gamida Cell ltd

    collaborator INDUSTRY

  • Loyola University

    lead OTHER

Principal Investigators

  • Patrick Stiff, MD · Loyola Universtiy Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
73 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2018-11-21
Completion
2018-11-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01484470 on ClinicalTrials.gov