Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031174
Status:
TERMINATED
Last Update Posted:
2020-08-21
First Post:
2002-02-26
Brief Title:
Blood Component Collection From Patients With Rheumatic or Kidney Disease and Healthy Volunteers
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Collection Of Blood Components Using Apheresis From Patients With Rheumatic or Kidney Diseases and Healthy Volunteers
Status:
TERMINATED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to technical and logistical constraints and a change in the study teams focus of research
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-AR-0131 | None | None | None |