Juvenile Idiopathic Arthritis (JIA)Phase 2NCT06623240
HB-adMSCs vs Placebo for the Treatment of Juvenile Idiopathic Arthritis
A Phase 2 study testing allogeneic Hope Biosciences adipose-derived mesenchymal stem cells and Normal Saline Solution 0.9% in people with Juvenile Idiopathic Arthritis (JIA), run by Hope Biosciences Research Foundation at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis (JIA)
- What is being tested?
- allogeneic Hope Biosciences adipose-derived mesenchymal stem cells and Normal Saline Solution 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The subject will be eligible for inclusion in this clinical trial only if all of the following criteria apply:
- Male and female subjects who are ≥ 2 years old and < 17 years old.
- a.The first 6 subjects enrolled must be ≥ 12 years old and < 17 years old
- Must be diagnosed with Oligoarticular or Polyarticular Juvenile Idiopathic Arthritis by a Pediatric Rheumatologist.
- Must have rheumatoid factor (RF) factor test result documented in medical records.
- Must have at least 3 affected joints at the screening visit.
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- Must have a body weight of > 10 kg at the screening visit.
- Subjects without a current established treatment for JIA who are not on treatment because they have failed at least 2 approved medications for their condition, or if being treated, subjects who are on a stable dose of arthritis therapy regimen for ≥3 months prior to screening.
- 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.
- Female study subjects of childbearing potential should not be pregnant or plan to become pregnant during study participation and for 6 months after the last investigational product administration. Female study subjects of childbearing potential must confirm usage of one of the following contraceptive measures:
- Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).
- Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).
- Barrier contraceptive methods (condoms, diaphragm, etc.).
- Male subjects if their sexual partners can become pregnant should ensure the use one of the following methods of contraception during study participation and for 6 months after the last administration of the investigated product.
- Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).
- Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).
- Barrier contraceptive methods (condoms, diaphragm, etc.).
- Study subject's parent(s)/LAR is/are able and willing to comply with the requirements of this clinical trial.
- Voluntarily signed informed consent from study subjects' parent(s) or legally authorized representative obtained before any clinical-trial related procedures are performed.
Who cannot join
- The subject will not be eligible for inclusion in this clinical trial if any of the following criteria apply:
- Study subject has any of the following laboratory results at the screening visit:
- WBC: <3000 cells/μL OR >15000 cells/μL (<3 K cells/μL or >15 K cells/μL)
- Hemoglobin: <8 g/dL
- Absolute Neutrophil Count: <1500 cells/μL
- Platelet: <150000 cells/μL (<150 K cells/μL)
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- Sodium: <120 mEq/L OR >150 mEq/L
- Glucose: >150 mg/dL
- Potassium: <3.5 mEq/L OR >6 mEq/L
- BUN: >25 mg/dL
- Creatinine: >2 mg/dL
- BUN/Creatinine ratio: >50
- AST: >100 U/L
- ALT: >100 U/L
- Study participant has any vital sign abnormalities at the screening visit as determined by the investigator.
- Study subject has 1 or more significant uncontrolled concurrent medical conditions (verified by medical records), including the following:
- Diabetes Mellitus
- Crohn's Disease
- Lupus
- Multiple Sclerosis
- Study subject has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma or melanoma.
- Study subject has known alcoholic addiction or dependency or has current substance use or abuse.
- Study subject has received any stem cell treatment within 1 year before first dose of investigational product other than stem cells produced by Hope Biosciences LLC.
- Receiving any investigational therapy or any approved therapy for investigational use within 1 year prior first dose of the investigational product other than COVID-19 vaccines.
- 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.
- Study subject with known concurrent acute or chronic viral hepatis B or C or human immunodeficiency virus (HIV) infection.
- Study subject with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hope Biosciences Research Foundation
Sugar Land, Texas, 77478
About this study
Official title: 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
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
Read the 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)
- Being tested
- allogeneic Hope Biosciences adipose-derived mesenchymal stem cells, Normal Saline Solution 0.9%
- Keywords
- JIA, juvenile idiopathic arthritis, juvenile arthritis, oligoarticular, polyarticular, polyarticular juvenile idiopathic arthritis, oligoarticular juvenile idiopathic arthritis, arthritis
- Medical subject headings
- Arthritis, Juvenile, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic Hope Biosciences adipose-derived mesenchymal stem cellsBiological
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)
Normal Saline Solution 0.9%Other
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)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 2: Group AB | Experimental | 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. Receives: Biological: allogeneic Hope Biosciences adipose-derived mesenchymal stem cells; Other: Normal Saline Solution 0.9% |
| Cohort 2: Group BA | Experimental | 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. Receives: Biological: allogeneic Hope Biosciences adipose-derived mesenchymal stem cells; Other: Normal Saline Solution 0.9% |
| Cohort 1: Group A | Experimental | Cohort 1 - Group A will receive allogeneic HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) at study weeks 0, 4, and 8. Receives: Biological: allogeneic Hope Biosciences adipose-derived mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs).
Treatment-emergent adverse events are defined as any adverse events which occur after the first infusion with HB-adMSCs up to the week 12 visit for Group AB or the week 32 visit for group BA.
Measured: Baseline (Week 0) up to Week 72
Incidence of serious adverse events (SAEs).
Incidence of serious Adverse Events (SAEs)
Measured: Baseline (Week 0) up to Week 72
Incidence and risk of AEs of particular interest (serious or nonserious)
Incidence and risk of AEs of particular interest (serious or nonserious), including thromboembolic events, infections, and hypersensitivities.
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in laboratory values results - Complete Blood Count (x10^3 Cells/uL)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (x10^3 Cells/uL)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in laboratory values results - Complete Blood Count (% of WBC)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (% of WBC)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in laboratory values results - Complete Blood Count (pg)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (pg)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in laboratory values results - Complete Blood Count (g/dL)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (g/dL)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in laboratory values results - Complete Blood Count (fL)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (fL)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in laboratory values results - Complete Blood Count (x10^6 Cells/uL)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (x10^6 Cells/uL)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in laboratory values results - Complete Blood Count (% Difference in Volume and Size of RBC)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (% Difference in Volume and Size of RBC)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in laboratory values results - Complete Blood Count (% of Total Blood Cell Count)
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (% of Total Blood Cell Count)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (g/dL)
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (g/dL)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (Ratio of Albumin to Calc. Globulin)
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (Ratio of Albumin to Calc. Globulin)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (U/L)
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (U/L)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mg/dL)
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mg/dL)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mEq/L)
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mEq/L)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mL/Min/1.73m^2)
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mL/Min/1.73m^2)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (Ratio of Calc BUN/Creatinine)
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (Ratio of Calc BUN/Creatinine)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in laboratory values results - Coagulation Panel (Seconds)
Clinically significant changes from Baseline in laboratory values results - Coagulation Panel (Seconds)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in laboratory values results - Coagulation Panel (Ratio of Prothrombin Time/Mean Prothrombin Time)
Clinically significant changes from Baseline in laboratory values results - Coagulation Panel (Ratio of Prothrombin Time/Mean Prothrombin Time)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in Vital Signs - Respiratory Rate (Breaths per minute)
Clinically significant changes from baseline in Respiratory Rate (Breaths per minute)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in Vital Signs - Heart Rate (Breaths per minute)
Clinically significant changes from baseline in Heart Rate (Breaths per minute)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in Vital Signs - Body Temperature (Celsius)
Clinically significant changes from baseline in Body Temperature (Celsius)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in Vital Signs - Systolic Blood Pressure (mmHg)
Clinically significant changes from baseline in Systolic Blood Pressure (mmHg)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in Vital Signs - Diastolic Blood Pressure (mmHg)
Clinically significant changes from baseline in Diastolic Blood Pressure (mmHg)
Measured: Baseline (Week 0) up to Week 72
Changes from Baseline in Vital Signs - SPO2 (%)
Clinically significant changes from baseline in SPO2 (%)
Measured: Baseline (Week 0) up to Week 72
Clinically significant changes in weight results (in kg)
Changes from Baseline in weight results in patients (in kg)
Measured: Baseline (Week 0) up to Week 72
Number of participants with abnormal physical examination results - Abdomen
Number of participants with abnormal physical examination results - Abdomen
Measured: Baseline (Week 0) up to Week 72
Number of participants with abnormal physical examination results - Cardiovascular
Number of participants with abnormal physical examination results - Cardiovascular
Measured: Baseline (Week 0) up to Week 72
Number of participants with abnormal physical examination results - Head, Eyes, Ears, Nose, and Throat
Number of participants with abnormal physical examination results - Head, Eyes, Ears, Nose, and Throat
Measured: Baseline (Week 0) up to Week 72
Number of participants with abnormal physical examination results - Lymph Node
Number of participants with abnormal physical examination results - Lymph Node
Measured: Baseline (Week 0) up to Week 72
Number of participants with abnormal physical examination results - Musculoskeletal
Number of participants with abnormal physical examination results - Musculoskeletal
Measured: Baseline (Week 0) up to Week 72
Number of participants with abnormal physical examination results - Neurological
Number of participants with abnormal physical examination results - Neurological
Measured: Baseline (Week 0) up to Week 72
Number of participants with abnormal physical examination results - Respiratory
Number of participants with abnormal physical examination results - Respiratory
Measured: Baseline (Week 0) up to Week 72
Number of participants with abnormal physical examination results - Skin
Number of participants with abnormal physical examination results - Skin
Measured: Baseline (Week 0) up to Week 72
Clinically significant changes in ACR Pedi 30
Changes from Baseline in ACR Pedi 30 in patients
Measured: Baseline (Week 0) up to Week 52 for Group AB or Week 72 for Group BA
Secondary outcomes (5)
Clinically significant changes in ACR Pedi 50
Changes from Baseline in ACR Pedi 50 in patients
Measured: Baseline (Week 0) up to Week 52 for Group AB or Week 72 for Group BA
Clinically significant changes in ACR Pedi 70
Changes from Baseline in ACR Pedi 70 in patients
Measured: Baseline (Week 0) up to Week 52 for Group AB or Week 72 for Group BA
Clinically significant changes in C-reactive protein values (mg/L)
Changes from Baseline in C-reactive protein values in patients (mg/L)
Measured: Baseline (Week 0) up to Week 52 for Group AB or Week 72 for Group BA
Clinically significant changes in erythrocyte sedimentation rate values (mm/h)
Changes from Baseline in erythrocyte sedimentation rate values in patients (mm/h)
Measured: Baseline (Week 0) up to Week 52 for Group AB or Week 72 for Group BA
Clinically significant changes in PedsQL
Changes from Baseline in PedsQL in patients
Measured: Baseline (Week 0) up to Week 52 for Group AB or Week 72 for Group BA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study startJan 2026 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Why it stopped: In the time that the site has been active, there have been 0 patients enrolled despite our best efforts. It is clear that it is not feasible to conduct this study at this time; therefore, we have withdrawn this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic Arthritis (JIA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is 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. Cohort 1 (first 6 patients) will undergo a screening period (up to 35 days) and an 8-week active treatment period, followed by a 64-week follow-up. Cohort 2 (remaining 60 patients) will undergo a screening period (up to 35 days), an 8-week active treatment period and an 8-week inactive treatment period (placebo) with a washout period of 12 weeks between the treatment periods. Subjects assigned to Cohort 2 - Group AB will receive allogeneic HB-adMSCs before the washout period, while subjects assigned to Cohort 2 - Group BA will receive allogeneic HB-adMSCs after the washout period. Group AB will undergo a safety follow-up of 64 weeks after their last infusion of HB-adMSCs, while Group BA will undergo a safety follow-up of 44 weeks after their last infusion of HB-adMSCs.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hope Biosciences Research Foundation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thanh Cheng, MD, Principal investigator, Hope Biosciences Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623240
- Sponsor's protocol ID
- HBJIA01
- Status last verified
- Jan 2026
- First submitted
- 30 Sep 2024
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06623240
- Acronym / sponsor ID
- HBJIA01
- Conditions
- Juvenile Idiopathic Arthritis (JIA)
- Keywords
- JIA, juvenile idiopathic arthritis, juvenile arthritis, oligoarticular, polyarticular, polyarticular juvenile idiopathic arthritis, oligoarticular juvenile idiopathic arthritis, arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: In the time that the site has been active, there have been 0 patients enrolled despite our best efforts. It is clear that it is not feasible to conduct this study at this time; therefore, we have withdrawn this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hope Biosciences Research FoundationIndustry (pharma, biotech, devices)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study is 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. Cohort 1 (first 6 patients) will undergo a screening period (up to 35 days) and an 8-week active treatment period, followed by a 64-week follow-up. Cohort 2 (remaining 60 patients) will undergo a screening period (up to 35 days), an 8-week active treatment period and an 8-week inactive treatment period (placebo) with a washout period of 12 weeks between the treatment periods. Subjects assigned to Cohort 2 - Group AB will receive allogeneic HB-adMSCs before the washout period, while subjects assigned to Cohort 2 - Group BA will receive allogeneic HB-adMSCs after the washout period. Group AB will undergo a safety follow-up of 64 weeks after their last infusion of HB-adMSCs, while Group BA will undergo a safety follow-up of 44 weeks after their last infusion of HB-adMSCs.
| Arm | Type | Receives |
|---|---|---|
| Cohort 2: Group AB | Experimental | Biological: allogeneic Hope Biosciences adipose-derived mesenchymal stem cells, Other: Normal Saline Solution 0.9%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. |
| Cohort 2: Group BA | Experimental | Biological: allogeneic Hope Biosciences adipose-derived mesenchymal stem cells, Other: Normal Saline Solution 0.9%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. |
| Cohort 1: Group A | Experimental | Biological: allogeneic Hope Biosciences adipose-derived mesenchymal stem cellsCohort 1 - Group A will receive allogeneic HB-adMSCs (Hope Biosciences adipose-derived mesenchymal stem cells) at study weeks 0, 4, and 8. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (19 listed)
- The subject will be eligible for inclusion in this clinical trial only if all of the following criteria apply:
- Male and female subjects who are ≥ 2 years old and < 17 years old.
- a.The first 6 subjects enrolled must be ≥ 12 years old and < 17 years old
- Must be diagnosed with Oligoarticular or Polyarticular Juvenile Idiopathic Arthritis by a Pediatric Rheumatologist.
- Must have rheumatoid factor (RF) factor test result documented in medical records.
Key exclusion criteria (29 listed)
- The subject will not be eligible for inclusion in this clinical trial if any of the following criteria apply:
- Study subject has any of the following laboratory results at the screening visit:
- Study participant has any vital sign abnormalities at the screening visit as determined by the investigator.
- Study subject has 1 or more significant uncontrolled concurrent medical conditions (verified by medical records), including the following:
- Study subject has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma or melanoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allogeneic Hope Biosciences adipose-derived mesenchymal stem cellsProduct: 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) | Biological | Cohort 1: Group A, Cohort 2: Group AB, Cohort 2: Group BA |
| 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) | Other | Cohort 2: Group AB, Cohort 2: Group BA |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs).
Time frame: Baseline (Week 0) up to Week 72
Treatment-emergent adverse events are defined as any adverse events which occur after the first infusion with HB-adMSCs up to the week 12 visit for Group AB or the week 32 visit for group BA.
Incidence of serious adverse events (SAEs).
Time frame: Baseline (Week 0) up to Week 72
Incidence of serious Adverse Events (SAEs)
Incidence and risk of AEs of particular interest (serious or nonserious)
Time frame: Baseline (Week 0) up to Week 72
Incidence and risk of AEs of particular interest (serious or nonserious), including thromboembolic events, infections, and hypersensitivities.
Changes from Baseline in laboratory values results - Complete Blood Count (x10^3 Cells/uL)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (x10^3 Cells/uL)
Changes from Baseline in laboratory values results - Complete Blood Count (% of WBC)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (% of WBC)
Changes from Baseline in laboratory values results - Complete Blood Count (pg)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (pg)
Changes from Baseline in laboratory values results - Complete Blood Count (g/dL)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (g/dL)
Changes from Baseline in laboratory values results - Complete Blood Count (fL)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (fL)
Changes from Baseline in laboratory values results - Complete Blood Count (x10^6 Cells/uL)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (x10^6 Cells/uL)
Changes from Baseline in laboratory values results - Complete Blood Count (% Difference in Volume and Size of RBC)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (% Difference in Volume and Size of RBC)
Changes from Baseline in laboratory values results - Complete Blood Count (% of Total Blood Cell Count)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from Baseline in laboratory values results - Complete Blood Count (% of Total Blood Cell Count)
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (g/dL)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (g/dL)
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (Ratio of Albumin to Calc. Globulin)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (Ratio of Albumin to Calc. Globulin)
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (U/L)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (U/L)
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mg/dL)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mg/dL)
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mEq/L)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mEq/L)
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mL/Min/1.73m^2)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (mL/Min/1.73m^2)
Changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (Ratio of Calc BUN/Creatinine)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from Baseline in laboratory values results - Comprehensive Metabolic Panel (Ratio of Calc BUN/Creatinine)
Changes from Baseline in laboratory values results - Coagulation Panel (Seconds)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from Baseline in laboratory values results - Coagulation Panel (Seconds)
Changes from Baseline in laboratory values results - Coagulation Panel (Ratio of Prothrombin Time/Mean Prothrombin Time)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from Baseline in laboratory values results - Coagulation Panel (Ratio of Prothrombin Time/Mean Prothrombin Time)
Changes from Baseline in Vital Signs - Respiratory Rate (Breaths per minute)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from baseline in Respiratory Rate (Breaths per minute)
Changes from Baseline in Vital Signs - Heart Rate (Breaths per minute)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from baseline in Heart Rate (Breaths per minute)
Changes from Baseline in Vital Signs - Body Temperature (Celsius)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from baseline in Body Temperature (Celsius)
Changes from Baseline in Vital Signs - Systolic Blood Pressure (mmHg)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from baseline in Systolic Blood Pressure (mmHg)
Changes from Baseline in Vital Signs - Diastolic Blood Pressure (mmHg)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from baseline in Diastolic Blood Pressure (mmHg)
Changes from Baseline in Vital Signs - SPO2 (%)
Time frame: Baseline (Week 0) up to Week 72
Clinically significant changes from baseline in SPO2 (%)
Clinically significant changes in weight results (in kg)
Time frame: Baseline (Week 0) up to Week 72
Changes from Baseline in weight results in patients (in kg)
Number of participants with abnormal physical examination results - Abdomen
Time frame: Baseline (Week 0) up to Week 72
Number of participants with abnormal physical examination results - Abdomen
Number of participants with abnormal physical examination results - Cardiovascular
Time frame: Baseline (Week 0) up to Week 72
Number of participants with abnormal physical examination results - Cardiovascular
Number of participants with abnormal physical examination results - Head, Eyes, Ears, Nose, and Throat
Time frame: Baseline (Week 0) up to Week 72
Number of participants with abnormal physical examination results - Head, Eyes, Ears, Nose, and Throat
Number of participants with abnormal physical examination results - Lymph Node
Time frame: Baseline (Week 0) up to Week 72
Number of participants with abnormal physical examination results - Lymph Node
Number of participants with abnormal physical examination results - Musculoskeletal
Time frame: Baseline (Week 0) up to Week 72
Number of participants with abnormal physical examination results - Musculoskeletal
Number of participants with abnormal physical examination results - Neurological
Time frame: Baseline (Week 0) up to Week 72
Number of participants with abnormal physical examination results - Neurological
Number of participants with abnormal physical examination results - Respiratory
Time frame: Baseline (Week 0) up to Week 72
Number of participants with abnormal physical examination results - Respiratory
Number of participants with abnormal physical examination results - Skin
Time frame: Baseline (Week 0) up to Week 72
Number of participants with abnormal physical examination results - Skin
Clinically significant changes in ACR Pedi 30
Time frame: Baseline (Week 0) up to Week 52 for Group AB or Week 72 for Group BA
Changes from Baseline in ACR Pedi 30 in patients
5 secondary outcomes
Clinically significant changes in ACR Pedi 50
Time frame: Baseline (Week 0) up to Week 52 for Group AB or Week 72 for Group BA
Clinically significant changes in ACR Pedi 70
Time frame: Baseline (Week 0) up to Week 52 for Group AB or Week 72 for Group BA
Clinically significant changes in C-reactive protein values (mg/L)
Time frame: Baseline (Week 0) up to Week 52 for Group AB or Week 72 for Group BA
Clinically significant changes in erythrocyte sedimentation rate values (mm/h)
Time frame: Baseline (Week 0) up to Week 52 for Group AB or Week 72 for Group BA
Clinically significant changes in PedsQL
Time frame: Baseline (Week 0) up to Week 52 for Group AB or Week 72 for Group BA
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thanh Cheng, MD principal investigator
Hope Biosciences Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing allogeneic Hope Biosciences adipose-derived mesenchymal stem cells and Normal Saline Solution 0.9% in people with Juvenile Idiopathic Arthritis (JIA), run by Hope Biosciences Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs). (time frame: Baseline (Week 0) up to Week 72). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.