Study of T Cell Maturation in Idiopathic CD4 Lymphocytopenia

This study is investigating Idiopathic CD4 Lymphocytopenia (ICL), a rare condition where your body has consistently low levels of CD4 T cells (a type of immune cell) without a clear cause like HIV. The goal is to understand how these immune cells develop and move within the body. Researchers will give participants two medications, Filgrastim and Plerixafor, to help release special stem cells (CD34+ hematopoietic progenitor cells) from their bone marrow into their bloodstream. These cells will then be collected through a process called apheresis and used in laboratory studies involving mice to learn more about ICL. The study aims to enroll 40 participants, including both ICL patients and healthy volunteers, aged 18 to 65 years old. To be eligible as an ICL patient, you must have a documented history of low CD4 T cell counts.

Study design
This is an interventional study with a planned enrollment of 40 participants. It includes both ICL patients and healthy volunteers.
What's involved
You would receive daily subcutaneous injections of Filgrastim for 5 days, followed by an intravenous injection of Plerixafor 11 hours before apheresis to collect cells.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, investigating thymic development, survival, and trafficking of cells, will be measured throughout the study.

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NCT02015013

Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models

Recruiting
PHASE2Ages 18–65InterventionalBasic science
National Institute of Allergy and Infectious Diseases (NIAID)
~40 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:FilgrastimPlerixafor

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To mobilize CD34+ HPCs in ICL patients and healthy volunteers for collection and transfer into immunocompromised mice to investigate thymic development, survival, and trafficking of these cells in murine lymphoid and non-lymphoid organs
Measured over Throughout the study
Idiopathic CD4-Positive
T-Lymphocytopenia
1 sites across 1 states
Maryland1
  • Irini Sereti, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)

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  • To mobilize CD34+ HPCs in ICL patients and healthy volunteers for collection and transfer into immunocompromised mice to investigate thymic development, survival, and trafficking of these cells in murine lymphoid and non-lymphoid organsThroughout the study

    Collection of CD34+ cells from ICL patients and healthy volunteers to investigate thymic development, survival, and trafficking of these mobilized cells in the lymphoid and non lymphoid organs of mice.