Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509828
Status:
AVAILABLE
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Expanded Access Protocol for STOMP-II Patients Who Were Unable to Receive Treatment Subsequent to Adipose Tissue Collection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Expanded Access Protocol for STOMP-II Patients Who Were Unable to Receive Treatment Subsequent to Adipose Tissue Collection EAP-STOMP2
Status:
AVAILABLE
Status Verified Date:
2024-07
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:
EAP-STOMP2
Brief Summary:
The goal of this Expanded Access Protocol is to provide expanded access of AVB-114 to patients who had their fat tissue collected as part of a clinical trial STOMP-II but who were subsequently not treated with AVB-114 because they did not meet all eligibility criteria or the investigational product was not successfully manufactured
Detailed Description:
AVB-114 is an autologous investigational product under evaluation in Seeded Cells on Matrix Plug Treating Crohns Perianal Fistulas STOMP-II a prospective multicenter randomized blinded outcome assessment controlled add-on therapy phase II study for the treatment of complex perianal fistulas in subjects with Crohns disease EAP-STOMP2 is an expanded access protocol for patients who had adipose tissue collected per the STOMP-II protocol but who were subsequently unable to receive AVB-114 treatment due to screen failure or product manufacturing issues and thus withdrew from the study Patients will receive AVB-114 as deemed appropriate by investigator and Avobis Bio
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: