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

Eligibility Criteria

• 1. Male and female subjects who are ≥ 2 years old and \< 17 years old.
• 2. Must be diagnosed with Oligoarticular or Polyarticular Juvenile Idiopathic Arthritis by a Pediatric Rheumatologist.
• 3. Must have rheumatoid factor (RF) factor test result documented in medical records.
• 4. Must have at least 3 affected joints at the screening visit.
• 5. Must have a body weight of \> 10 kg at the screening visit.
• 6. 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.
• 7. 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.
• 8. 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.).
• 9. 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.).
• 10. Study subject's parent(s)/LAR is/are able and willing to comply with the requirements of this clinical trial.
• 11. Voluntarily signed informed consent from study subjects' parent(s) or legally authorized representative obtained before any clinical-trial related procedures are performed.
• 1. Study subject has any of the following laboratory results at the screening visit:
• 1. WBC: \<3000 cells/μL OR \>15000 cells/μL (\<3 K cells/μL or \>15 K cells/μL)
• 2. Hemoglobin: \<8 g/dL
• 3. Absolute Neutrophil Count: \<1500 cells/μL
• 4. Platelet: \<150000 cells/μL (\<150 K cells/μL)
• 5. Sodium: \<120 mEq/L OR \>150 mEq/L
• 6. Glucose: \>150 mg/dL
• 7. Potassium: \<3.5 mEq/L OR \>6 mEq/L
• 8. BUN: \>25 mg/dL
• 9. Creatinine: \>2 mg/dL
• 10. BUN/Creatinine ratio: \>50
• 11. AST: \>100 U/L
• 12. ALT: \>100 U/L
• 2. Study participant has any vital sign abnormalities at the screening visit as determined by the investigator.
• 3. Study subject has 1 or more significant uncontrolled concurrent medical conditions (verified by medical records), including the following:
• 1. Diabetes Mellitus
• 2. Crohn's Disease
• 3. Lupus
• 4. Multiple Sclerosis
• 4. Study subject has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma or melanoma.
• 5. Study subject has known alcoholic addiction or dependency or has current substance use or abuse.
• 6. 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.
• 7. 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.
• 8. 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.
• 9. Study subject's parent(s)/LAR unable to understand and provide signed informed consent.
• 10. Study subject and/or study subject's parent(s)/LAR unlikely to complete the study or adhere to the study procedures.
• 11. Study subject with known concurrent acute or chronic viral hepatis B or C or human immunodeficiency virus (HIV) infection.
• 12. Study subject with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product.