Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623240
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
HB-adMSCs vs Placebo for the Treatment of Juvenile Idiopathic Arthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-Blind Phase 2 Efficacy and Safety Cross-Over Study of Allogeneic HB-adMSCs vs Placebo for the Treatment of Oligoarticular and Polyarticular Juvenile Idiopathic Arthritis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
Methodology Randomized double-blind ABBA cross-over study with a washout period of 12 weeks
Treatment Duration 8 weeks per group
General Objectives To assess the efficacy and safety of multiple intravenous infusions of allogeneic HB-adMSCs by improving signs and symptoms of juvenile idiopathic arthritis in this subject population
Number of Subjects 66
Indication Juvenile Idiopathic Arthritis
Primary Objectives
To assess the safety of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with oligoarticular or polyarticular juvenile idiopathic arthritis as determined by the incidence of adverse events or serious adverse events Time Frame Week 0 to Week 72
To investigate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with oligoarticular or polyarticular juvenile idiopathic arthritis as determined by improvements in ACR Pedi 30 scores Time Frame Week 0 to Week 52 for Group AB and Week 0 to Week 72 for Group BA
Secondary Objectives
To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with oligoarticular or polyarticular juvenile idiopathic arthritis as determined by improvements in ACR Pedi 50 scores Time Frame Week 0 to Week 52 for Group AB and Week 0 to Week 72 for Group BA
To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with oligoarticular or polyarticular juvenile idiopathic arthritis as determined by improvements in ACR Pedi 70 scores Time Frame Week 0 to Week 52 for Group AB and Week 0 to Week 72 for Group BA
To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with oligoarticular or polyarticular juvenile idiopathic arthritis as determined by improvements in CRP values Time Frame Week 0 to Week 52 for Group AB and Week 0 to Week 72 for Group BA
To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with oligoarticular or polyarticular juvenile idiopathic arthritis as determined by improvements in ESR values Time Frame Week 0 to Week 52 for Group AB and Week 0 to Week 72 for Group BA
To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with oligoarticular or polyarticular juvenile idiopathic arthritis as determined by improvements in Peds QL scores Time Frame Week 0 to Week 52 for Group AB and Week 0 to Week 72 for Group BA
Treatment Duration 8 weeks per group
General Objectives To assess the efficacy and safety of multiple intravenous infusions of allogeneic HB-adMSCs by improving signs and symptoms of juvenile idiopathic arthritis in this subject population
Number of Subjects 66
Indication Juvenile Idiopathic Arthritis
Primary Objectives
To assess the safety of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with oligoarticular or polyarticular juvenile idiopathic arthritis as determined by the incidence of adverse events or serious adverse events Time Frame Week 0 to Week 72
To investigate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with oligoarticular or polyarticular juvenile idiopathic arthritis as determined by improvements in ACR Pedi 30 scores Time Frame Week 0 to Week 52 for Group AB and Week 0 to Week 72 for Group BA
Secondary Objectives
To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with oligoarticular or polyarticular juvenile idiopathic arthritis as determined by improvements in ACR Pedi 50 scores Time Frame Week 0 to Week 52 for Group AB and Week 0 to Week 72 for Group BA
To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with oligoarticular or polyarticular juvenile idiopathic arthritis as determined by improvements in ACR Pedi 70 scores Time Frame Week 0 to Week 52 for Group AB and Week 0 to Week 72 for Group BA
To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with oligoarticular or polyarticular juvenile idiopathic arthritis as determined by improvements in CRP values Time Frame Week 0 to Week 52 for Group AB and Week 0 to Week 72 for Group BA
To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with oligoarticular or polyarticular juvenile idiopathic arthritis as determined by improvements in ESR values Time Frame Week 0 to Week 52 for Group AB and Week 0 to Week 72 for Group BA
To evaluate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with oligoarticular or polyarticular juvenile idiopathic arthritis as determined by improvements in Peds QL scores Time Frame Week 0 to Week 52 for Group AB and Week 0 to Week 72 for Group BA
Detailed Description:
None
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