A Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety Study of Allogeneic HB-adMSCs vs Placebo for the Treatment of Patients With Parkinson's Disease

HBPD04

This is a randomized, double-blind, single center, phase 2 study to assess efficacy and safety of multiple allogeneic HB-adMSCs vs Placebo for the treatment of Parkinson's disease.

2021-07-16

2025-12-15

2026-01-15

Recruiting

Early phase I

60

Inclusion Criteria: * A study participant will be eligible for inclusion in this study only if all the following 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 score between 7 and 28. 3. Study participants must have an MDS-UPDRS part III score between 20 and 57 during the screening visit. 4. Carbidopa/Levodopa total dosage must be less than 1200 mg per day for study participants. 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 moderate Parkinson's disease at least 2 years prior study participation. 7. Study participants should be able to read, understand and to provide written consent. 8. Voluntarily signed informed consent obtained before any clinical-trial related procedures are performed. 9. Female study participants should not be pregnant or plan to become pregnant during study participation and for 6 months after last investigational product administration. 10. Male participants if their sexual partners can become pregnant should use a method of contraception during study participation and for 6 months after the last administration of the investigated product. 11. Study participant is able and willing to comply with the requirements of this clinical trial. Exclusion Criteria: * A study participant will not be eligible for inclusion in this clinical trial if any of the following criteria apply: 1. Pregnancy, lactation. Women of childbearing age who are not pregnant but do not take effective contraceptive measures. 2. Study participants with advanced Parkinson's disease described as, severe disability, wheelchair bound or bedridden. 3. Study participant has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma or melanoma. 4. Study participant has known alcoholic addiction or dependency or has current substance 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 deficient standard of care treatment and/or pre-prandial glucose \>130mg/dl during screening visit or post-prandial glucose \>200mg/dl. * Medical History of Chronic kidney disease (CKD) diagnosis and/or screening results of eGFR \< 59mL/min/1.73m2. * Presence of New York Heart Association (NYHA) Class III/IV heart failure during screening visit. * Any medical history of myocardial infarction in any of the different types, such as ST-elevation myocardial infarction (STEMI) or non-ST-elevated myocardial infarction (NSTEMI), coronary spasm, or unstable angina. * Medical history of uncontrolled high blood pressure defined as a deficient standard of care treatment and/or blood pressure \> 180/120 mm/Hg during screening visit. * Medical history of inherited thrombophilias, recent major general surgery, (within 12 months before the Screening), lower extremity paralysis due to spinal cord injury, fracture of the pelvis, hips or femur, cancer of the lung, brain, lymphatic, gynecologic system (ovary or uterus), or gastrointestinal 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 before first dose of investigational product other than stem cells produced by Hope Biosciences. 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 participant has a laboratory abnormality during screening, including the following: * White blood cell count \< 3000/mm3 * Platelet count \< 80,000mm3 * Absolute neutrophil count \< 1500/mm3 * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 10 upper limit of normal (ULN) x 1.5 9. Study participant 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. 10. Study participant is unlikely to complete the study or adhere to the study procedures. 11. Study participant with known concurrent acute or chronic viral hepatis B or C or human immunodeficiency virus (HIV) infection. 12. Study participant has a previously diagnosed psychiatric condition which in the opinion of the investigator may affect self-assessments. 13. Study participant with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product. 14. Male study participants who plan to donate sperm during the study or within 6 months after the last dose. Female patients who plan to donate eggs or undergo in vitro fertilization treatment during the study or within 6 months after the last dose.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A parallel study is a type of clinical study where two groups of treatments, A (allogeneic HB-adMSCs) and B (Placebo), are given so that one group receives only A while another group receives only B.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Study subjects, investigators and study staff will be blinded to the assigned treatment.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2023-11-07