Back to resultscliniMACs HUD for T Cell Depletion
Primary Purpose
x Linked Combined Immunodeficiency
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
CliniMACs
Sponsored by
About this trial
This is an expanded access trial for x Linked Combined Immunodeficiency
Eligibility Criteria
Inclusion Criteria:
severe combined immune deficiency need for stem cell boost
Exclusion Criteria:
n/a
Sites / Locations
- University of Miami
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT02915406
First Posted
September 23, 2016
Last Updated
August 12, 2017
Sponsor
University of Miami
Collaborators
Jackson Health System
1. Study Identification
Unique Protocol Identification Number
NCT02915406
Brief Title
cliniMACs HUD for T Cell Depletion
Official Title
cliniMACs HUD for T Cell Depletion
Study Type
Expanded Access
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Jackson Health System
4. Oversight
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
x Linked Combined Immunodeficiency
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
CliniMACs
10. Eligibility
Sex
All
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
Inclusion Criteria:
severe combined immune deficiency need for stem cell boost
Exclusion Criteria:
n/a
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Kleiner, MDPhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Learn more about this trial
cliniMACs HUD for T Cell Depletion
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