Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001756
Status:
COMPLETED
Last Update Posted:
2022-11-07
First Post:
1999-11-03
Brief Title:
Study of Mast Cell Precursors
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Characterization of CD34 Derived Mast Cell Precursors
Status:
COMPLETED
Status Verified Date:
2022-11
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:
This study will investigate mast cell precursors that circulate in the blood In a group of diseases collectively known as mastocytosis mast cells accumulate in abnormal amounts in the skin lymphoid tissues bone marrow liver and spleen Some forms of mastocytosis have a generally good prognosis for others the prognosis is poorer There is no known cure for any form of the disease A better understanding of mast cells and how they respond to certain substances may provide insights that will lead to effective treatments for mastocytosis
Patients with systemic mastocytosis and normal healthy volunteers between the ages of 20 and 60 may be eligible for this 8-day study Participants will undergo the following procedures
Day 1 Medical history physical examination and blood tests to assess general health status
Days 2 through 6 Daily injections under the skin of G-CSF a hormone that stimulates white blood cell production
Day 7 Leukapheresis a procedure for collecting large numbers of white blood cells In leukapheresis blood is drawn through a needle placed in an arm and channeled into a cell separator machine The white cells are collected and the rest of the blood is returned to the body through a needle in the other arm The procedure takes up to 3 hours
Days 7 and 8 Blood draw about 1 teaspoon to monitor white blood cell counts
Patients with systemic mastocytosis and normal healthy volunteers between the ages of 20 and 60 may be eligible for this 8-day study Participants will undergo the following procedures
Day 1 Medical history physical examination and blood tests to assess general health status
Days 2 through 6 Daily injections under the skin of G-CSF a hormone that stimulates white blood cell production
Day 7 Leukapheresis a procedure for collecting large numbers of white blood cells In leukapheresis blood is drawn through a needle placed in an arm and channeled into a cell separator machine The white cells are collected and the rest of the blood is returned to the body through a needle in the other arm The procedure takes up to 3 hours
Days 7 and 8 Blood draw about 1 teaspoon to monitor white blood cell counts
Detailed Description:
The purpose of this protocol is to obtain large numbers of CD34 cells from the peripheral blood of healthy volunteers and patients with systemic mastocytosis or other related allergic hematological and immunological conditions by leukapheresis for culture and characterization of mast cell progenitor cells and their response to various cytokines and anti-mitotic agents Healthy volunteers and patients will be adults of both sexes from 18 to 70 years of age Granulocyte colony stimulating factor G-CSF will be administered to healthy volunteers at dose of 10 mcgkgday as a subcutaneous dose daily for 5 days not to exceed 960mcg Patients will receive Plerixafor at a dose of 024 mgkg as a single subcutaneous dose not to exceed 24mg the night before leukapheresis as a mobilizing agent for CD34 cells In identified patients where leukapheresis yield is considered adequate without stimulation by the principal investigator leukapheresis may proceed without stimulation Healthy volunteers will undergo a single leukapheresis at day 7 and patients will undergo a single leukapheresis at day 3 or 4 This is not a therapeutic protocol and does not involve reinfusion of any manipulated cells viruses or DNA constructs back into human subjects
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 |
|---|---|---|---|
| 98-I-0027 | None | None | None |