Clinical trial NCT00031174: Blood Component Collection From Patients With Rheumatic or Kidney Disease and Healthy Volunteers
Official title: Collection Of Blood Components Using Apheresis From Patients With Rheumatic or Kidney Diseases and Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rheumatic Diseases
Healthy Volunteers
Keywords: Apheresis
Healthy Volunteer
Rheumatoid Disease
Rheumatic Disease
Lupus
Rheumatoid Arthritis
Myositis
HV
Normal Control
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-02-27
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Rheumatic or kidney diseases and healthy volunteers.

Brief summary: This study will collect white blood cells or plasma (the liquid part of the blood), or both, from healthy volunteers and from patients with rheumatic or kidney disorders for research purposes. Rheumatic disorders involve abnormalities of the immune system, the body s defense against disease. The immune system consists of white blood cells such as lymphocytes and monocytes, which produce substances such as antibodies and cytokines. White cells and plasma will be collected through a procedure called apheresis (described below).

Healthy volunteers and patients with confirmed or suspected rheumatic or kidney disease who are 18 years of age or older may be eligible for this study. Patients must be participating in a current protocol of the National Institute of Arthritis and Musculoskeletal and Skin Diseases or the National Institute of Digestive, Diabetes and Kidney Diseases. All candidates will be screened with a history, physical examination, and blood tests for hepatitis B and C and HIV infection. Women of childbearing age will be tested for pregnancy. Routine blood tests will be done in all volunteers, and in patients where needed. Pregnant women and people who test positive for hepatitis or HIV may not participate.

Participants will undergo apheresis to collect lymphocytes, monocytes, or plasma from the blood. For this procedure, a needle is placed in a vein in the arm. Blood flows from the vein through a tube (catheter) into a machine that spins the blood, separating it into its components. The required cells or plasma are extracted, and the rest of the blood, including the red cells and platelets, is returned to the body through the same needle or through a second needle placed in the other arm.

Cells collected from volunteers will be used in studies comparing the number and function of similar cells from patients with rheumatic diseases, focusing on the differences in number and function of the cells in health and disease. Components collected from patients will be used only for studies described in the protocol in which they are currently enrolled.

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Detailed description: Blood components will be collected using apheresis from normal volunteers and patients with rheumatic or kidney diseases. Mononuclear cells and plasma will be used by various investigators for research studies.

Eligibility criteria: * INCLUSION CRITERIA - Subjects with Rheumatic Diseases:

Patients with a diagnosed or suspected rheumatic or kidney disease, who are actively involved in a NIAMS or NIDDK protocol (have a current, signed consent form)

Ability to give informed consent

Age greater than or equal to 18 years

EXCLUSION CRITERIA - Subjects with Rheumatic Diseases:

History of allergy to acid-citrate-dextrose (ACD) anticoagulant

History of bleeding diatheses

Hemoglobin less than 9.0 g/dL

Platelet count less than 50,000/mm(3)

Pregnancy

Inadequate peripheral venous access

Active hepatitis B, C and/or HIV infection

Symptomatic coronary artery or valvular heart disease

Any concomitant illness that in the opinion of the investigators will substantially increase the risk of apheresis.

INCLUSION CRITERIA - Healthy Volunteers:

Subjects shall meet all donor eligibility criteria for autologous blood donation recommended or required by the Standards of the American Association of Blood Banks (1) and the Code of Federal Regulations of the Food and Drug Administration (2), with the exception of the travel exclusions related to malaria exposure and hypothetical exposure to the agent of variant Creutzfeldt-Jacob disease.

Ability to give informed consent

Age greater than or equal to 18 years

EXCLUSION CRITERIA - Healthy Volunteers:

History of autoimmune or chronic rheumatic disease within the last 5 years, with the exception of osteoarthritis

Active hepatitis B, C, and/or HIV infection

History of allergy to acid-citrate (ACD) anticoagulant

History of coagulopathies and bleeding diatheses

Symptomatic coronary artery disease or valvular heart disease

Hemoglobin less than 12.0 g/dL

Platelet count less than 100,000/cubic mm

Pregnancy

Inadequate peripheral venous access

Any concomitant illness that in the opinion of the investigators will substantially increase the risk of apheresis or make the volunteer ineligible for study controls are needed for (eg: active infection, allergies, etc.)

Primary outcomes:
measure: PBMC and Mononuclear cell study
timeFrame: 1/1/2030
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: Sarfaraz A Hasni, M.D.
role: PRINCIPAL_INVESTIGATOR
References: