Stem Cells for Juvenile Arthritis

Overseen By Michelle Biedron

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Hope Biosciences

Disqualifiers: Diabetes, Crohn's, Lupus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks per group

66 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Thanh C Cheng, MD

Principal Investigator

Hope Biosciences Research Foundation

Eligibility Criteria

This trial is for children with juvenile idiopathic arthritis, specifically those with oligoarticular or polyarticular forms. Participants must be eligible based on certain health criteria not specified here.

Inclusion Criteria

Study subject's parent(s)/LAR is/are able and willing to comply with the requirements of this clinical trial

Must have rheumatoid factor (RF) factor test result documented in medical records

Must have an abnormal CRP result and/or abnormal ESR result at screening. Abnormal C-reactive protein (CRP) value defined as > 1 mg/dL. Abnormal Erythrocyte Sedimentation Rate (ESR) value defined as >15 mm/hr for males and >20 mm/hr for females

Exclusion Criteria

Study subject has any other laboratory abnormality or medical condition which, in the opinion of the investigator, poses a safety risk or will prevent the subject from completing the study

Study subject's parent(s)/LAR unable to understand and provide signed informed consent

Study subject and/or study subject's parent(s)/LAR unlikely to complete the study or adhere to the study procedures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either allogeneic HB-adMSCs or placebo in a cross-over design with a washout period

8 weeks per group

3 visits (in-person) per treatment period

Washout

A washout period between treatment phases to eliminate the effects of the first treatment before starting the second

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 72 weeks

Treatment Details

Interventions

• allogeneic Hope Biosciences adipose-derived mesenchymal stem cells

Trial Overview The study tests the safety and effectiveness of HB-adMSCs (a type of stem cell therapy) against a placebo (saline solution). It's a randomized, double-blind crossover study where participants switch between treatments after an 8-week period and a 12-week break.

Participant Groups

Group I: Cohort 2: Group BA Experimental Treatment 2 Interventions

Cohort 2 - Group BA will receive placebo (Sterile Saline Solution 0.9%) at study weeks 0, 4, and 8. Then, Group BA will receive allogeneic HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) at weeks 20, 24, and 28 after a washout period of 12 weeks between placebo and active treatment.

Group II: Cohort 2: Group AB Experimental Treatment 2 Interventions

Cohort 2 - Group AB will receive allogeneic HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) at study weeks 0, 4, and 8. Then, Group AB will receive placebo (Sterile Saline Solution 0.9%) at weeks 20, 24, and 28 after a washout period of 12 weeks between active treatment and placebo.

Group III: Cohort 1: Group A Experimental Treatment 1 Intervention

Cohort 1 - Group A will receive allogeneic HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) at study weeks 0, 4, and 8.

Who Is Running the Clinical Trial?

Hope Biosciences

Lead Sponsor

Trials

27

Recruited

470+