Randomized, Double-Blind Clinical Trial for Parkinson's Disease (Early and Moderate)

NCT ID: NCT04928287

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-28
• Study Completion Date: 2023-02-06

Brief Summary

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

The trial includes a screening period of up to 4 weeks, a 32-week treatment period, and a safety Follow-up period of 20 weeks after the last investigational product administration.

This clinical trial will be open to enroll 24 eligible participants diagnosed with Parkinson's disease. Patients' recruitment will be conducted by the study team, if eligible participants are identified based on eligibility criteria, a screening visit will be scheduled. Informed consent form will be given to the study participants and signed before any study procedures. Informed consent form will include information about the clinical trial and some aspects should be considered during this process.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HB-adMSCs

Autologous Hope Biosciences adipose derived mesenchymal stem cells.

Group Type: ACTIVE_COMPARATOR

HB-adMSCs

Intervention Type: BIOLOGICAL

HB-adMSCs will be administered intravenously to study participants who qualify.

Placebo

Intervention Type: OTHER

Placebo will be administered intravenously to study participants who qualify.

Placebo

Sterile Saline Solution 0.9%

Group Type: PLACEBO_COMPARATOR

HB-adMSCs

Intervention Type: BIOLOGICAL

HB-adMSCs will be administered intravenously to study participants who qualify.

Placebo

Intervention Type: OTHER

Placebo will be administered intravenously to study participants who qualify.

Interventions

HB-adMSCs

HB-adMSCs will be administered intravenously to study participants who qualify.

Intervention Type: BIOLOGICAL

Placebo

Placebo will be administered intravenously to study participants who qualify.

Intervention Type: OTHER

Other Intervention Names

Autologous Hope Biosciences adipose derived mesenchymal stem cells.; Sterile Saline Solution 0.9%

Eligibility Criteria

Inclusion Criteria

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

1. Male and female participants 18 - 75 years of age.

2. Study participant must have been diagnosed with early and/or moderate Parkinson's disease at least 6 months before study participation.

3. Study participants must have previously banked their mesenchymal stem cells with Hope Biosciences.

4. Study participants should be able to read, understand and to provide written consent.

5. Voluntarily signed informed consent obtained before any clinical-trial related procedures are performed.

6. Female study participants should not be pregnant or plan to become pregnant during study participation and for 6 months after last investigational product administration.

7. 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.

8. 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 hepatitis 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.

15. Study participants who are determined by the Investigator to be unsuitable for study enrollment for other reasons

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hope Biosciences Research Foundation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Djamchid Lotfi, MD

Role: PRINCIPAL_INVESTIGATOR

Hope Biosciences Stem Cell Research Foundation

Locations

Hope Biosciences Stem Cell Research Foundation

Sugar Land, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

HBPD03

Identifier Type: -

Identifier Source: org_study_id