Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522035
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-07
Brief Title:
Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis
Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
This is an open label study to evaluate the safety and initial efficacy of intra-articular administration of Allocetra in patients with Psoriatic Arthritis PsA
Detailed Description:
Psoriatic Arthritis PsA is a prevalent chronic inflammatory disease that mainly affects the synovial joints and leads to inflammatory arthritis in addition to skin manifestations If left untreated inflammatory arthritis leads to joint damage and deformities
Allocetra is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state
As macrophages play a crucial role in the initiation of PsA immunopathogenesis they are considered an emerging target for PsA treatment
This study will assess the safety of Allocetra injection to the joint knee elbow or ankle in patients with PsA and evaluate the preliminary responses to treatment
Allocetra is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state
As macrophages play a crucial role in the initiation of PsA immunopathogenesis they are considered an emerging target for PsA treatment
This study will assess the safety of Allocetra injection to the joint knee elbow or ankle in patients with PsA and evaluate the preliminary responses to treatment
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