cliniMACs HUD for T Cell Depletion
August 12, 2017 updated by: Gary Kleiner, University of Miami
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 Overview
Status
No longer available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
severe combined immune deficiency need for stem cell boost
Exclusion Criteria:
n/a
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gary Kleiner, MDPhD, University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
September 23, 2016
First Submitted That Met QC Criteria
September 23, 2016
First Posted (Estimate)
September 27, 2016
Study Record Updates
Last Update Posted (Actual)
August 16, 2017
Last Update Submitted That Met QC Criteria
August 12, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20160472
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.