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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of using stem cells (special cells that can grow into different types of cells) to treat juvenile idiopathic arthritis, a condition causing joint pain and swelling in children. Participants will receive either the allogeneic Hope Biosciences adipose-derived mesenchymal stem cell treatment or a placebo (a harmless substance resembling the treatment) over two periods, with a break in between. Children diagnosed with either oligoarticular or polyarticular juvenile idiopathic arthritis, who have at least three affected joints and have not found success with at least two other treatments, might be suitable for this trial. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group, offering a chance to potentially benefit from a promising new therapy.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications. However, you must be on a stable dose of arthritis therapy for at least 3 months before joining if you are currently being treated.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Hope Biosciences stem cells, derived from fat tissue, have been tested in conditions like rheumatoid arthritis in adults and have shown promise. Researchers are studying these stem cells to determine their potential in alleviating joint inflammation and pain.

Previous patients have demonstrated that treatments with similar stem cells are generally well-tolerated, with most people not experiencing serious side effects. However, individual experiences can vary, and some may encounter mild reactions.

This study focuses on juvenile idiopathic arthritis, a condition causing joint pain and swelling in children. As the study is in its early phase, researchers are closely monitoring the safety of these stem cells to identify any unwanted side effects promptly.

Overall, while promising evidence exists from other uses of these stem cells, this trial is still exploring the safety and effectiveness of the treatment specifically for juvenile arthritis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for juvenile arthritis?

Researchers are excited about using allogeneic Hope Biosciences adipose-derived mesenchymal stem cells (HB-adMSCs) for juvenile arthritis because these stem cells offer a novel approach to treating the condition. Unlike standard treatments such as nonsteroidal anti-inflammatory drugs (NSAIDs) or disease-modifying antirheumatic drugs (DMARDs) that primarily address symptoms, HB-adMSCs have the potential to target inflammation at a cellular level and promote tissue repair. This treatment harnesses the body's own regenerative capabilities, which could lead to more sustainable and long-term relief for patients. Additionally, the use of adipose-derived stem cells is promising due to their ability to differentiate into a variety of cell types, potentially offering a broader therapeutic effect.

What evidence suggests that this trial's treatments could be effective for juvenile idiopathic arthritis?

Research has shown that a type of stem cell treatment, called allogeneic HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells), may help with conditions like juvenile idiopathic arthritis. In adults, these stem cells have benefited those with rheumatoid arthritis, chronic pain, and other joint problems. Studies have found that these cells can improve joint function and lessen symptoms. They may help by reducing inflammation and aiding healing in the affected joints. In this trial, participants in different groups will receive either the stem cell treatment or a placebo at various stages. The researchers aim to observe similar positive results in younger patients with juvenile idiopathic arthritis. ^{1 2 3 4 6}

Who Is on the Research Team?

Thanh C Cheng, MD

Principal Investigator

Hope Biosciences Research Foundation

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Hope Biosciences Research Foundation

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06623240

Study Details | NCT06623240 | HB-adMSCs vs Placebo for ... To investigate the efficacy of intravenous infusions of allogeneic HB-adMSCs vs placebo in patients with oligoarticular or polyarticular juvenile idiopathic ...

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/546822

HB-adMSCs vs Placebo for the Treatment of Juvenile ... Methodology: Randomized, double-blind, AB/BA cross-over study with a washout period of 12 weeks. Treatment Duration: 8 weeks per group

3. trial.medpath.com trial.medpath.com/clinical-trial/388851b70a8db31c/nct06623240-randomized-double-blind-allogeneic-hb-admscs-placebo-juvenile-idiopathic-arthritis

HB-adMSCs vs Placebo for the Treatment of Juvenile ... Methodology: Randomized, double-blind, AB/BA cross-over study with a washout period of 12 weeks. Treatment Duration: 8 weeks per group

4. synapse.patsnap.com synapse.patsnap.com/drug/ef161d2aebdc4e7c8b514b690fef8199

HB-adMSCs(Hope Biosciences) - Drug Targets, Indications ... HB-adMSCs have shown promise in Rheumatoid Arthritis in adults, as well as in chronic musculoskeletal pain, osteoarthritis, psoriatic arthritis, and lupus.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35241141/

a phase I/IIa, open-label, non-randomized pilot trial The results indicated that a single, intravenous administration of autologous adMSCs is safe and efficacious for improvement in joint function in patients with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8896321/

Safety and efficacy of autologous, adipose-derived ... The results indicated that a single, intravenous administration of autologous adMSCs is safe and efficacious for improvement in joint function in patients with ...