Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459063
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-10
Brief Title:
Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint
Sponsor:
Kaplan Medical Center
Organization:
Kaplan Medical Center
Study Overview
Official Title:
A Placebo-controlled Study of Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint
Status:
RECRUITING
Status Verified Date:
2024-06
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 is a single center trial to assess the safety and efficacy of intra-articular administration of Allocetra to patients with 1st CMC thumb joint osteoarthritis OA
Detailed Description:
Osteoarthritis OA of the first carpometacarpal CMC joint or basal joint of the thumb is a common painful and debilitating disease For patients whose symptoms persist despite conservative therapies and rehabilitation strategies surgery remains the last-resort 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
This study is a single center safety and efficacy assessment trial to assess intra-articular administration of Allocetra in patients suffering from thumb osteoarthritis in the 1st CMC joint basal thumb joint who have not responded sufficiently to conventional therapies
The study is comprised of a safety run-in stage to characterize safety of Allocetra injections at different doses followed by a placebo-controlled double-blind randomized stage to evaluate the safety and efficacy of Allocetra injection to the basal thumb joint
Patients will be followed for up to a year following 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
This study is a single center safety and efficacy assessment trial to assess intra-articular administration of Allocetra in patients suffering from thumb osteoarthritis in the 1st CMC joint basal thumb joint who have not responded sufficiently to conventional therapies
The study is comprised of a safety run-in stage to characterize safety of Allocetra injections at different doses followed by a placebo-controlled double-blind randomized stage to evaluate the safety and efficacy of Allocetra injection to the basal thumb joint
Patients will be followed for up to a year following treatment
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None