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

Inclusion Criteria:

The subject will be eligible for inclusion in this clinical trial only if all of the following criteria apply:

1. 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

2. Must be diagnosed with Oligoarticular or Polyarticular Juvenile Idiopathic Arthritisby 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 treatmentbecause they have failed at least 2 approved medications for their condition, or ifbeing treated, subjects who are on a stable dose of arthritis therapy regimen for ≥3months prior to screening.

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

8. Female study subjects of childbearing potential should not be pregnant or plan tobecome pregnant during study participation and for 6 months after the lastinvestigational product administration. Female study subjects of childbearingpotential 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 oneof the following methods of contraception during study participation and for 6months 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 therequirements of this clinical trial.

11. Voluntarily signed informed consent from study subjects' parent(s) or legallyauthorized representative obtained before any clinical-trial related procedures areperformed.

Exclusion Criteria:

The subject will not be eligible for inclusion in this clinical trial if any of the following criteria apply:

1. Study subject has any of the following laboratory results at the screening visit:

2. WBC: <3000 cells/μL OR >15000 cells/μL (<3 K cells/μL or >15 K cells/μL)

3. Hemoglobin: <8 g/dL

4. Absolute Neutrophil Count: <1500 cells/μL

5. Platelet: <150000 cells/μL (<150 K cells/μL)

6. Sodium: <120 mEq/L OR >150 mEq/L

7. Glucose: >150 mg/dL

8. Potassium: <3.5 mEq/L OR >6 mEq/L

9. BUN: >25 mg/dL

10. Creatinine: >2 mg/dL

11. BUN/Creatinine ratio: >50

12. AST: >100 U/L

13. ALT: >100 U/L

14. Study participant has any vital sign abnormalities at the screening visit asdetermined by the investigator.

15. Study subject has 1 or more significant uncontrolled concurrent medical conditions (verified by medical records), including the following:

16. Diabetes Mellitus

17. Crohn's Disease

18. Lupus

19. Multiple Sclerosis

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

21. Study subject has known alcoholic addiction or dependency or has current substanceuse or abuse.

22. Study subject has received any stem cell treatment within 1 year before first doseof investigational product other than stem cells produced by Hope Biosciences LLC.

23. Receiving any investigational therapy or any approved therapy for investigationaluse within 1 year prior first dose of the investigational product other thanCOVID-19 vaccines.

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

25. Study subject's parent(s)/LAR unable to understand and provide signed informedconsent.

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

27. Study subject with known concurrent acute or chronic viral hepatis B or C or humanimmunodeficiency virus (HIV) infection.

28. Study subject with any systemic infection requiring treatment with antibiotics,antivirals, or antifungals within 30 days prior to first dose of the investigationalproduct.