Comparative Autoantibody and Immunologic Cell Marker Study

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.

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

- Healthy controls must be free of acute or chronic disease at the time of bone marrow
donation

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).

- Insufficient access to the iliac crest and bone is hindered. This generally correlates
to a BMI (Body Mass Index) of greater than 25.0.