cliniMACs HUD for T Cell Depletion

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Brief Title

cliniMACs HUD for T Cell Depletion

Official Title

cliniMACs HUD for T Cell Depletion

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
    



Study Type

Expanded Access




Condition

x Linked Combined Immunodeficiency

Intervention

CliniMACs


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device





Eligibility Criteria

        Inclusion Criteria:

        severe combined immune deficiency need for stem cell boost

        Exclusion Criteria:

        n/a
      

Gender

All

Ages

N/A - 65 Years


Contacts

Gary Kleiner, MDPhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02915406

Organization ID

20160472


Responsible Party

Principal Investigator

Study Sponsor

University of Miami

Collaborators

 Jackson Health System

Study Sponsor

Gary Kleiner, MDPhD, Principal Investigator, University of Miami


Verification Date

August 2017