MedTrace Logo

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

NCT06623240 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-01-07

No results posted yet for this study

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

Conditions

  • Juvenile Idiopathic Arthritis (JIA)

Interventions

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)

Sponsors & Collaborators

  • Hope Biosciences Research Foundation

    lead INDUSTRY

Principal Investigators

  • Thanh Cheng, MD · Hope Biosciences Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-01-31
Completion
2026-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06623240 on ClinicalTrials.gov