Clinical Trial for Parkinson's Disease Using Allogeneic HB-adMSCs (Early and Moderate PD)

Inclusion Criteria:

• A study participant will be eligible for inclusion in this study only if all thefollowing criteria apply:

1. Male and female participants 45 - 80 years of age.

2. At the screening visit, study participants must have an MDS-UPDRS part II scorebetween 7 and 28.

3. Study participants must have an MDS-UPDRS part III score between 20 and 57during the screening visit.

4. Carbidopa/Levodopa total dosage must be less than 1200 mg per day for studyparticipants.

5. The total Levodopa equivalent dose for study participants must be less than 1400 mg per day.

6. Study participant must have been diagnosed with early and/or moderateParkinson's disease at least 2 years prior study participation.

7. Study participants should be able to read, understand and to provide writtenconsent.

8. Voluntarily signed informed consent obtained before any clinical-trial relatedprocedures are performed.

9. Female study participants should not be pregnant or plan to become pregnantduring study participation and for 6 months after last investigational productadministration.

10. Male participants if their sexual partners can become pregnant should use amethod of contraception during study participation and for 6 months after thelast administration of the investigated product.

11. Study participant is able and willing to comply with the requirements of thisclinical trial.

Exclusion Criteria:

• A study participant will not be eligible for inclusion in this clinical trial if anyof the following criteria apply:

1. Pregnancy, lactation. Women of childbearing age who are not pregnant but do nottake effective contraceptive measures.

2. Study participants with advanced Parkinson's disease described as, severedisability, wheelchair bound or bedridden.

3. Study participant has any active malignancy, including evidence of cutaneousbasal, squamous cell carcinoma or melanoma.

4. Study participant has known alcoholic addiction or dependency or has currentsubstance use or abuse.

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

• Poorly controlled diabetes mellitus (PCDM) defined as history of deficientstandard of care treatment and/or pre-prandial glucose >130mg/dl duringscreening visit or post-prandial glucose >200mg/dl.
• Medical History of Chronic kidney disease (CKD) diagnosis and/or screeningresults of eGFR < 59mL/min/1.73m2.
• Presence of New York Heart Association (NYHA) Class III/IV heart failureduring screening visit.
• Any medical history of myocardial infarction in any of the differenttypes, such as ST-elevation myocardial infarction (STEMI) ornon-ST-elevated myocardial infarction (NSTEMI), coronary spasm, orunstable angina.
• Medical history of uncontrolled high blood pressure defined as a deficientstandard of care treatment and/or blood pressure > 180/120 mm/Hg duringscreening visit.
• Medical history of inherited thrombophilias, recent major general surgery, (within 12 months before the Screening), lower extremity paralysis due tospinal cord injury, fracture of the pelvis, hips or femur, cancer of thelung, brain, lymphatic, gynecologic system (ovary or uterus), orgastrointestinal tract (like pancreas or stomach).
• History of brain surgery for Parkinson's disease.

6. Study participant has received any stem cell treatment within 6 months beforefirst dose of investigational product other than stem cells produced by HopeBiosciences.

7. Receiving any investigational therapy or any approved therapy forinvestigational use within 1 year prior first dose of the investigationalproduct other than COVID-19 vaccines.

8. Study participant has a laboratory abnormality during screening, including thefollowing:

• White blood cell count < 3000/mm3
• Platelet count < 80,000mm3
• Absolute neutrophil count < 1500/mm3
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 10upper limit of normal (ULN) x 1.5

9. Study participant has any other laboratory abnormality or medical conditionwhich, in the opinion of the investigator, poses a safety risk or will preventthe subject from completing the study.

10. Study participant is unlikely to complete the study or adhere to the studyprocedures.

11. Study participant with known concurrent acute or chronic viral hepatis B or Cor human immunodeficiency virus (HIV) infection.

12. Study participant has a previously diagnosed psychiatric condition which in theopinion of the investigator may affect self-assessments.

13. Study participant with any systemic infection requiring treatment withantibiotics, antivirals, or antifungals within 30 days prior to first dose ofthe investigational product.

14. Male study participants who plan to donate sperm during the study or within 6months after the last dose. Female patients who plan to donate eggs or undergoin vitro fertilization treatment during the study or within 6 months after thelast dose.