Blood Component Collection From Patients With Rheumatic or Kidney Disease and Healthy Volunteers

NCT00031174 | Terminated

• 2 other identifiers: 02013102-AR-0131
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

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. ...

Conditions

Rheumatic Diseases; Healthy Volunteers

Keywords

Apheresis; Healthy Volunteer; Rheumatoid Disease; Rheumatic Disease; Lupus; Rheumatoid Arthritis; Myositis; HV; Normal Control

Outcome Measures

Primary Outcomes (1)

• PBMC and Mononuclear cell study

  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.

  1/1/2030

Study Arms (2)

1

Blood components collected using apheresis from normal volunteers.

2

Blood components collected using apheresis from patients with rheumatic or kidney diseases.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Rheumatic or kidney diseases and healthy volunteers.

You may qualify if:

• 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

You may not qualify if:

• 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.
• Ability to give informed consent
• Age greater than or equal to 18 years
• 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

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Rheumatic Diseases; Arthritis, Rheumatoid; Myositis

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Arthritis; Joint Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Sarfaraz A Hasni, M.D.

  National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2002
• First Posted: February 27, 2002
• Study Start: February 13, 2002
• Primary Completion: August 17, 2020
• Study Completion: August 17, 2020
• Last Updated: August 21, 2020

Record last verified: 2020-08

Locations

US (1)