Comparative Autoantibody and Immunologic Cell Marker Study

Study Purpose

The purpose of this study is to compare immune phenotype, function, and specificity of B lymphocytes from different developmental stages in autoimmune patients to B cells from infectious disease patients and healthy controls.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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. 1. Subjects with acute exacerbations of their disease, including hospitalized patients. 2. First-degree relatives of subjects with active disease.
  • - 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 Criteria:

  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02422875
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Emory University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ignatio Sanz, MD
Principal Investigator Affiliation Emory University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherNIH
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Autoimmune Diseases, Lupus Erythematosus, Systemic, Communicable Diseases
Additional Details

Systemic lupus erythematosus (SLE) is an autoimmune disease (in autoimmune illness, the immune system in the body attacks it's own cells, leading to illness). It is not completely understood how this disease develops in the body. In a normal person, there is a tolerance of antigens (substances that make antibodies, which protect the body from disease-causing agents). Research in mice suggests that defects in certain types of cells can make the body lose this tolerance, therefore recognizing antigens made in the body as foreign, and mounting an immune response to the "self", thus causing autoimmune disease. In this study, the researchers will look at these potentially defective cells in people with SLE and other autoimmune diseases and compare them to cells in healthy participants, as well as looking at the blood of first-degree relatives of people with autoimmune disease. The study involves blood draws and bone marrow aspirates. Participants may be asked to donate 2/3 to about 9 tablespoons of blood. The volume of blood needed will depend on the experiment being done as different numbers of cells are necessary to run different experiments. Study participants may return for additional blood draws will not donate blood more than twice a week, and will not have more than 16 tablespoons of blood drawn in a one-month period. Participants donating bone marrow will have about 3 ½ tablespoons of bone marrow obtained, which will be drawn with a large needle from the bone located in the back of the hip. Bone marrow participants may be asked to donate up to 7 tablespoons of blood as well, in order to correlate the blood with the bone marrow sample and the populations of cells residing in each. Participants donating bone marrow may donate more than once, but must wait a minimum of 8 weeks between donations.

Arms & Interventions

Arms

: Healthy Controls

Subjects are healthy persons without any autoimmune conditions or infectious diseases

: Autoimmune Disease

Subjects diagnosed with autoimmune disease including but not limited to: Systemic Lupus Erythematosus (SLE), Sjögren's Syndrome (SS), Scleroderma, Myositis, Juvenile Idiopathic Arthritis (JIA), Rheumatoid Arthritis (RA), inflammatory arthritis, undifferentiated connective tissue disease, idiopathic thrombocytopenic purpura (ITP), Graft vs Host Disease (GVHD), Autoimmune Lymphoproliferative Syndrome (ALPS) and IgG4-related disease

: Infectious Disease

Subjects diagnosed with an infectious disease including but not limited to: Hepatitis C, Epstein Barr Virus (infectious mononucleosis - EBV), Sepsis, Guillain-Barre syndrome (GBS), Mycoplasma pneumoniae or Human Immunodeficiency Virus (HIV)

: Autoimmune - Family

Subjects have a brother, sister, mother, father, or child with an autoimmune disease

: Vaccination

Subjects have received or will receive a vaccination as part of regular standard of care from their healthcare provider or other outside source

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Emory University Hospital, Atlanta, Georgia

Status

Address

Emory University Hospital

Atlanta, Georgia, 30322

Atlanta, Georgia

Status

Address

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322

Grady Health System, Atlanta, Georgia

Status

Address

Grady Health System

Atlanta, Georgia, 30322