NCT02915406

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

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

First QC Date

September 23, 2016

Last Update Submit

August 12, 2017

Conditions

x Linked Combined Immunodeficiency

Interventions

CliniMACsDEVICE

Eligibility Criteria

AgeUp to 65 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • severe combined immune deficiency need for stem cell boost

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

X-Linked Combined Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSevere Combined ImmunodeficiencyPrimary Immunodeficiency DiseasesInfant, Newborn, DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Gary Kleiner, MDPhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

September 23, 2016

First Posted

September 27, 2016

Last Updated

August 16, 2017

Record last verified: 2017-08

Locations

US(1)