NCT02422875
Comparative Autoantibody and Immunologic Cell Marker Study
Enrolling by Invitation
Not specifiedAges 18+ObservationalEmory UniversityInvestigator-initiated
~2,500 participants
Updated 2025-09-30 on ClinicalTrials.gov
At a glance
Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Distribution of autoreactive B cells within bone marrow
Measured over Baseline
Conditions
Where it's being run
3 sites across 1 statesGeorgia3
Study leadership
- Ignatio Sanz, MD · PRINCIPAL_INVESTIGATOR · Emory University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Signed written informed consent by the subject or, if the subject is unable to provide informed consent, the subject's legal representative may provide consent.
Subjects can be of either gender
Subjects with autoimmune diseases, and Systemic Lupus Erythematosus (SLE) patients will fulfill the American College of Rheumatology Classification criteria for SLE to be determined by their treating physician but may have incomplete criteria (\<4 items). SLE patients are not restricted by treatment or by disease activity as determined by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) or Systemic Lupus Activity Measure (SLAM) score
Subjects who have received or will receive a vaccination may be enrolled for bone marrow aspirates before and/or after vaccination. Vaccination will have been done by the subject's healthcare provider or through another outside source.
Subjects may have a screening blood draw performed in cases where a certain subset of cells or antibody titer is desired. This may be followed by additional blood draws and/or bone marrow aspiration after the ideal candidates have been identified.
Subjects who have been diagnosed with HIV or another infectious disease
Subjects taking biologic and/or immune modulatory agents in diseases such as cancer, allergy, and pulmonary diseases will be enrolled.
Healthy controls must be free of acute or chronic disease at the time of bone marrow donation. Healthy controls that are first-degree relatives of subjects with active disease will be enrolled as well.
Exclusion
Poor venous access
Subjects who have had side effects to local anesthetics such as lidocaine and who are on blood thinners such as warfarin
Normal controls must be free of acute or chronic diseases or medications that may affect the assay (as determined by the investigator).
For subjects donating bone marrow, insufficient access to the iliac crest such that the periosteum and bone is hindered based on normal aspiration procedures.
Pregnant or lactating women may not donate bone marrow.
What this trial measures
- Distribution of autoreactive B cells within bone marrowBaseline
B cells will be analyzed using flow cytometry.