Blood Component Collection From Patients With Rheumatic or Kidney Disease and Healthy Volunteers
Collection Of Blood Components Using Apheresis From Patients With Rheumatic or Kidney Diseases and Healthy Volunteers
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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調査の概要
詳細な説明
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Maryland
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Bethesda、Maryland、アメリカ、20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
- 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.)
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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1
Blood components collected using apheresis from normal volunteers.
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2
Blood components collected using apheresis from patients with rheumatic or kidney diseases.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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PBMC and Mononuclear cell study
時間枠：1/1/2030
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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.
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1/1/2030
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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。