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

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Disease Information

Descriptive Information
Brief Title † Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Official Title † Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Brief Summary Idiopathic CD4 lymphocytopenia (ICL) is a rare syndrome defined by consistently low CD4 T cell counts (
Detailed Description Idiopathic CD4 lymphocytopenia (ICL) is a rare syndrome defined by consistently low CD4 T cell counts (
Study Phase N/A
Study Type † Observational
Study Design †
Primary Outcome Measure † to assess peripheral CD4 T cell and CD34 plus hematopoietic progenitor cell numbers and functions in ICL patients compared to controls following G-CSF and plerixafor administration.
Secondary Outcome Measure †
Condition † T-Lymphocytopenia, Idiopathic CD4-Positive
Intervention †
Study Arms / Comparison Groups
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 †
Estimated Enrollment † 40
Start Date † November 19, 2013
Completion Date January 1, 2019
Primary Completion Date October 31, 2017
Eligibility Criteria † - INCLUSION CRITERIA ICL patients: 1. Documented history of idiopathic CD4 lymphocytopenia as defined by CD4 T cell count 2500/mm(3) and hemoglobin greater than or equal to 12.5 g/dL ICL patients and healthy volunteers: 1. Age 18-65 years 2. Weight at least 50 kg but less than 167 kg and 160 mmHg or resting diastolic blood pressure >90 mmHg) despite pharmacologic antihypertensive treatment confirmed with a second blood pressure measurement done later on the same day 13. Cardiac, pulmonary, thyroid, renal, hepatic, neurological (central or peripheral) disease or disorder of hemostasis requiring therapy and considered to be significant by the protocol team 14. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements 15. Currently receiving Lithium due to contraindication of co-administration of G-CSF with lithium 16. Past or current psychiatric illness that, in the opinion of the investigator, would interfere with protocol adherence or the ability to give written informed consent 17. Any illness or condition that, in the opinion of the investigator, may substantially increase the risk associated with participation in the study or compromise the scientific objectives 18. Participation in a clinical protocol which includes an intervention that, in the opinion of the investigator, may affect the results of the current study 19. Previous history of anaphylactic reaction to aspirin or other NSAIDS 20. Female of child-bearing potential who is breast-feeding.
Gender All
Ages 18 Years - 65 Years
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts †† Megan V Anderson, R.N., (301) 761-7323, megan.anderson2@nih.gov
Location Countries † United States
Administrative Information
NCT ID † NCT02015013
Organization ID 140020
Secondary IDs †† 14-I-0020
Responsible Party Sponsor
Study Sponsor † National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ††
Investigators † Principal Investigator: Irini Sereti, M.D., National Institute of Allergy and Infectious Diseases (NIAID)
Information Provided By
Verification Date January 26, 2017
First Received Date † December 13, 2013
Last Updated Date June 15, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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