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cliniMACs HUD for T Cell Depletion

Sponsor
University of Miami (Other)
Overall Status
No longer available
CT.gov ID
NCT02915406
Collaborator
Jackson Health System (Other)
1
Location

Study Details

Study Description

Brief Summary

This protocol is designed to enable access to related or unrelated CD34 cells manufactured using the CliniMACS (Miltenyi) under the HUD designation for patients needing T cell depleted allogeneic grafts for hematopoietic stem cell transplant (HSCT). This will include patients with inherited immunodeficiency disorders as well as patients with malignancies, bone marrow failure, and other rare diseases amenable to HSCT. Finally, patients with poor graft function and Graft Versus Host Disease(GVHD) after a previous HSCT may require a boost of T-cell depleted donor Peripheral Blood Stem Cell (PBSCs) or bone marrow cells that are CD34 selected using the CliniMACS device ENROLLMENT BY INVITATION ONLY

Condition or Disease Intervention/Treatment Phase
  • Device: CliniMACs

Study Design

Study Type:
Expanded Access
Official Title:
cliniMACs HUD for T Cell Depletion

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 65 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    severe combined immune deficiency need for stem cell boost

    Exclusion Criteria:

    n/a

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Miami Miami Florida United States 33136

    Sponsors and Collaborators

    • University of Miami
    • Jackson Health System

    Investigators

    • Principal Investigator: Gary Kleiner, MDPhD, University of Miami

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gary Kleiner, Associate Professor of Pediatrics, University of Miami
    ClinicalTrials.gov Identifier:
    NCT02915406
    Other Study ID Numbers:
    • 20160472
    First Posted:
    Sep 27, 2016
    Last Update Posted:
    Aug 16, 2017
    Last Verified:
    Aug 1, 2017
    Additional relevant MeSH terms:
    X-Linked Combined Immunodeficiency Diseases

    Study Results

    No Results Posted as of Aug 16, 2017