A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) for the Treatment of Rheumatoid Arthritis

This is a Phase 1/2a open label single dose study in subjects with active Rheumatoid
Arthritis (RA). 12-15 patients will be enrolled for the study. The overall objective of this
study is to evaluate the safety profile of a single IV infusion of autologous adipose-derived
mesenchymal stem cells (HB-adMSCs) in subjects with clinical diagnosis of RA. The primary
endpoint of this study is to measure the number and frequency of adverse event(s) and/or
severe adverse event(s) throughout the study duration. The second endpoint of this study is
to evaluate the ability of HB-adMSCs to alter RA-related inflammation via measuring levels of
Tumor Necrosis Factor alpha (TNF-a), Interleukin-6 (IL-6), C-Reactive Protein (CRP),
Erythrocyte Sedimentation Rate (ESR) and Joint Count 66/68 after a single infusion of
autologous HB-adMSCs for up to 12-month post-infusion.

Inclusion Criteria:

- Adult male or female between the ages of 18 and 65

- Patients have active RA as confirmed by the following criteria:

- ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline (68-joint
count)

- Abnormal CRP result OR abnormal ESR result at screening. Abnormal CRP result at
screening OR abnormal ESR defined as:

- CRP > 4.9 mg/L or ESR > 10mm/hr for men, > 20mm/hr for women

- Patients without current established treatment, or if being treated, patients who are
on a stable dose of RA therapy regimen for ≥ 4 weeks prior to screening

Exclusion Criteria:

- Inability to understand and provide signed informed consent

- Pregnancy, lactation, or, if female of childbearing potential, positive serum
β-hCG at baseline.

- Currently diagnosed any malignant neoplasm. Any patient who was successfully
treated for cancer and has been disease-free, with no recurrence, for at least 5
years, will be considered.

- Uncontrolled systemic illness, including, but not limited to: hypertension
(systolic >150 mm Hg or diastolic >95 mm Hg); diabetes; renal, hepatic, or
cardiac failure or any laboratory abnormality that poses a safety risk to the
subject such as:

- Hemoglobin ≤8.5 g/dL

- White blood cells (WBCs) ≤3,500/mm3 (3.5G/L)

- Any other illness which, in the opinion of the investigator, characterizes
the subject as not being a good candidate for the study

- Participation in another study with an investigational drug or device within 4
weeks prior to treatment or 5 half-lives of the investigational product used
(whichever is longer).

- Positive results of hepatitis B surface antigen (HBsAg), hepatitis B surface
antibody (HBsAb), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCV
Ab), and/or human immunodeficiency virus antibody (HIV Ab) tests at screening
(excluding patients who are tested positive for HBsAb alone due to a hepatitis B
vaccination).

- Positive history of Treponema pallidum.