Stem Cell Therapy

Stem Cells for Juvenile Arthritis

Sugar Land, TX

Phase 2

Recruiting

Led By Thanh Cheng, MD

Research Sponsored by Hope Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with Oligoarticular or Polyarticular Juvenile Idiopathic Arthritis

Must have at least 3 affected joints at the screening visit

Must not have

Study subject has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma or melanoma

Study subject has 1 or more significant uncontrolled concurrent medical conditions (verified by medical records), including Diabetes Mellitus, Crohn's Disease, Lupus, Multiple Sclerosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 0) up to week 52 for group ab or week 72 for group ba

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test the safety and effectiveness of multiple intravenous infusions of stem cells in treating juvenile idiopathic arthritis. The study will involve 66 subjects and will last for 8 weeks per

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Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects are not detailed in the provided information but would typically include reactions at the infusion site, possible immune responses to stem cells, or other unforeseen events related to treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a form of juvenile arthritis.

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I have at least 3 joints affected by my condition.

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I weigh more than 10 kilograms.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active cancer, including skin cancers like basal or squamous cell carcinoma or melanoma.

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I have a serious health condition like diabetes or MS that is not under control.

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I haven't had any stem cell treatments in the last year, except those from Hope Biosciences LLC.

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I have hepatitis B, C, or HIV.

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I have not taken antibiotics, antivirals, or antifungals for an infection in the last 30 days.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 0) up to week 52 for group ab or week 72 for group ba

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 0) up to week 52 for group ab or week 72 for group ba

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0) up to week 52 for group ab or week 72 for group ba for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes from Baseline in Vital Signs - Body Temperature (Celsius)

Changes from Baseline in Vital Signs - Diastolic Blood Pressure (mmHg)

Changes from Baseline in Vital Signs - Heart Rate (Breaths per minute)

+33 more

Secondary study objectives

Clinically significant changes in ACR Pedi 50

Clinically significant changes in ACR Pedi 70

Clinically significant changes in C-reactive protein values (mg/L)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 2: Group BAExperimental Treatment2 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 ABExperimental Treatment2 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 AExperimental Treatment1 Intervention

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

0 / 8Eligibility criteria met