NCT06623240

HB-adMSCs vs Placebo for the Treatment of Juvenile Idiopathic Arthritis

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• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hope Biosciences Research Foundation · Industry
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

Methodology: Randomized, double-blind, AB/BA 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 (6 subjects in Cohort 1 and 60 subjects in Cohort 2) Indication: Juvenile Idiopathic Arthritis

Detailed description

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).

Conditions

• Juvenile Idiopathic Arthritis (JIA)

Interventions

Type	Name	Description
BIOLOGICAL	allogeneic Hope Biosciences adipose-derived mesenchymal stem cells	Product: Allogeneic HB-adMSCs (Hope Biosciences adipose derived mesenchymal stem cells) Dose determined by body weight: * 50 million cells in 50mL saline: ≥ 10 kg to \< 22 kg * 100 million cells in 100mL saline: ≥ 22 kg to \< 45 kg * 200 million cells in 250mL saline: ≥ 45 kg Route: Intravenous Regimen: Weeks 0, 4, and 8 (Cohort 1: Group A and Cohort 2: Group AB) or Weeks 20, 24, and 28 (Cohort 2: Group BA)
OTHER	Normal Saline Solution 0.9%	Product: Normal Saline Solution 0.9% Route: Intravenous Regimen: Weeks 0, 4, and 8 (Cohort 2: Group BA) or Weeks 20, 24, and 28 (Cohort 2: Group AB)

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2024-10-02
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study