Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2025-12-16 @ 4:47 PM
Study NCT ID:
NCT06442761
Status:
None
Last Update Posted:
2025-09-09 00:00:00
First Post:
2024-05-13 00:00:00
Brief Title:
SCD Stem Cell Mobilization and Apheresis Using Motixafortide
Sponsor:
St Jude Childrens Research Hospital
Organization:
St. Jude Children's Research Hospital
Study Overview
Official Title:
Sickle Cell Disease Stem Cell Mobilization and Apheresis Using Motixafortide
Status:
None
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is divided into 2 parts. Participants will be assigned to a part based on when they enroll. Early in the study, participants will be assigned to part A. Later in the study, participants will be assigned to part B. In both parts, participants will receive the study drug, motixafortide, by an injection under the skin. About 8 hours after the injection, stem cells will be collected. Participants will follow-up within 7-10 days after the study drug and stem cell collection. Study staff will contact participants about 30 (±3) days after the last drug dose administration. The follow up may be conducted in person if the participant is in clinic during that follow up period.
Detailed Description:
This study is divided into 2 parts Participants will be assigned to a part based on when they enroll Early in the study participants will be assigned to part A Later in the study participants will be assigned to part B In both parts participants will receive the study drug motixafortide by an injection under the skin About 8 hours after the injection stem cells will be collected Participants will follow-up within 7-10 days after the study drug and stem cell collection Study staff will contact participants about 30 days after the last drug dose administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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