Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001214
Status:
COMPLETED
Last Update Posted:
2020-08-21
First Post:
1999-11-03
Brief Title:
Collection of Blood From Patients With Pancytopenia
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Lymphocytapheresis of Patients With Pancytopenia
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aplastic anemia is a condition in which the cells normally found in blood are greatly decreased The normal levels of white blood cells red blood cells and platelets are much lower in patients with aplastic anemia
Because of these low levels of blood cells patients with aplastic anemia have a variety of immune system abnormalities However low levels of blood cells make it difficult to collect specialized white blood cells mononuclear cells for research studies
This study was designed to collect lymphocytes from patients with low levels of all blood cells pancytopenia for use in research Patients participating in the study will undergo a special procedure known as lymphapheresis During lymphapheresis blood is taken from the patient in a manner similar to blood donation The white blood cells are selectively removed by spinning centrifugation and the remaining red blood cells and platelets are placed back re-infused into the donor s blood stream
Patients participating in this study will not benefit directly from it However cells collected in this study may increase scientific knowledge and improve understanding and treatment for diseases like aplastic anemia
Because of these low levels of blood cells patients with aplastic anemia have a variety of immune system abnormalities However low levels of blood cells make it difficult to collect specialized white blood cells mononuclear cells for research studies
This study was designed to collect lymphocytes from patients with low levels of all blood cells pancytopenia for use in research Patients participating in the study will undergo a special procedure known as lymphapheresis During lymphapheresis blood is taken from the patient in a manner similar to blood donation The white blood cells are selectively removed by spinning centrifugation and the remaining red blood cells and platelets are placed back re-infused into the donor s blood stream
Patients participating in this study will not benefit directly from it However cells collected in this study may increase scientific knowledge and improve understanding and treatment for diseases like aplastic anemia
Detailed Description:
Patients with aplastic anemia myelodysplasia and other marrow failure syndromes have a variety of immunologic abnormalities including lymphocyte phenotypic and lymphokine production dysregulation Because of their low blood counts it has been difficult to obtain sufficient peripheral blood mononuclear cells for research studies Patients agreeing to this protocol will be lymphapheresed the equivalent of one or two units of cells approximately 1-2 x 108 cells which will be used for research purposes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 86-H-0088 | None | None | None |