Blood Component Collection From Patients With Rheumatic or Kidney Disease and Healthy Volunteers
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies, Renal Impairment / Chronic Kidney Disease, Rheumatology |
| Therapuetic Areas: | Nephrology / Urology, Rheumatology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/2/2019 |
| Start Date: | February 13, 2002 |
| Contact: | Sarfaraz A Hasni, M.D. |
| Email: | hasnisa@mail.nih.gov |
| Phone: | (301) 451-1599 |
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.
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.
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.
rheumatic or kidney diseases. Mononuclear cells and plasma will be used by various
investigators for research studies.
- 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.)
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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