Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-05 @ 5:20 PM
Study NCT ID:
NCT06522035
Status:
RECRUITING
Last Update Posted:
2025-08-19
First Post:
2024-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis
Sponsor:
Enlivex Therapeutics Ltd.
Organization:
Study Overview
Official Title:
Evaluation of Allocetra by Intra-articular Injection for the Treatment of Psoriatic Arthritis
Status:
RECRUITING
Status Verified Date:
2025-08
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:
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:
False
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?:
False
Is an FDA AA801 Violation?: