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Expanded Cord Blood in Patients in Need of an Allogeneic Stem Cell Transplant

NCT02668315 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-08-05

No results posted yet for this study

Summary

Allogeneic hematopoietic stem cell transplantation is a life-saving procedure in patients with blood cancers, but only 25% of transplant candidates have a sibling donor. A matched unrelated donor can be found for 60% of patients but this number is lower for non-Caucasians. Cord blood (CB), another source of stem cells, has major advantages over unrelated donors including immediate availability, better permissiveness in immune mismatches between donor and transplant recipient, better availability for non-Caucasians, and less graft versus host disease, a complication frequently seen after transplant which negatively affects quality of life. Unfortunately, the use of CB is still limited in adults because of the small number of stem cells. UM171, a molecule with hematopoietic stem cell expansion properties, has been shown to increase cord blood stem cells 13 fold. In this trial, Investigators will use UM171 treated CB in patients who need a transplant but lack an acceptable donor.This protocol seeks to test the safety of CB cells expanded with UM171, and to determine the kinetics of engraftment as well as the minimal cord blood unit cell dose that when expanded achieves prompt engraftment.

Conditions

  • Hematologic Malignancy

Interventions

BIOLOGICAL

Transplantation of cord blood expanded with UM171

Myeloablative or submyeloablative conditioning regimen followed by an expanded cord blood transplant

Sponsors & Collaborators

  • Canadian Cancer Society (CCS)

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Hopital de l'Enfant-Jesus

    collaborator OTHER

  • Vancouver General Hospital

    collaborator OTHER

  • St. Justine's Hospital

    collaborator OTHER

  • Stem Cell Network

    collaborator OTHER

  • Maisonneuve-Rosemont Hospital

    lead OTHER

Principal Investigators

  • Sandra Cohen, MD · Maisonneuve-Rosemont Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
3 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-16
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • Canada

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 NCT02668315 on ClinicalTrials.gov