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

NCT04928287 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: HBPD03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (23)

• Change From Baseline in MDS-UPDRS Part II.

  The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.

  Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

• Laboratory Values. CBC (% of WBC)

  Changes from baseline in CBC laboratory values with unit of % of white blood cell count.

  Baseline (Week 0), Week 24, and End of Study (Week 52)

• Laboratory Values. CBC (10^9 Cells/L)

  Changes from baseline in CBC laboratory values with units of 10\^9 cells/L (Leukocytes, Platelets)

  Baseline (Week 0), Week 24, and End of Study (Week 52)

• Laboratory Values. CBC (10^12 Cells/L)

  Changes from baseline in CBC laboratory values with units of 10\^12 cells/L.

  Baseline (Week 0), Week 24, and End of Study (Week 52)

• Laboratory Values. CBC (pg)

  Changes from baseline in CBC laboratory values with unit of pg.

  Baseline (Week 0), Week 24, and End of Study (Week 52)

• Laboratory Values. CBC (fL)

  Changes from baseline in CBC laboratory values with unit of fL.

  Baseline (Week 0), Week 24, and End of Study (Week 52)

• Laboratory Values. CBC (g/dL)

  Changes from baseline in CBC laboratory values with unit of g/dL.

  Baseline (Week 0), Week 24, and End of Study (Week 52)

• Laboratory Values. CBC (% Difference in Volume and Size of RBC)

  Changes from baseline in CBC laboratory values with unit of % difference in volume and size of RBC

  Baseline (Week 0), Week 24, and End of Study (Week 52)

• Laboratory Values. CBC (% of Total Blood Cell Count)

  Changes from baseline in CBC laboratory values with unit of % of total blood cell count.

  Baseline (Week 0), Week 24, and End of Study (Week 52)

• Vital Signs. - Blood Pressure (mmHg)

  Change from baseline in Blood Pressure.

  Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

• Weight in kg.

  Change from baseline in Weight in kg.

  Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

• Laboratory Values. CMP (mg/dL)

  Change from baseline in CMP values with units of mg/dL

  Baseline (Week 0), Week 24, and End of Study (Week 52)

• Laboratory Values. CMP (g/dL)

  Changes from baseline in CMP laboratory values with units of g/dL

  Baseline (Week 0), Week 24, and End of Study (Week 52)

• Laboratory Values. CMP (IU/L)

  Changes from baseline in CMP laboratory values with units of IU/L.

  Baseline (Week 0), Week 24, and End of Study (Week 52)

• Laboratory Values. CMP (mL/Min/1.73m^2)

  Changes from baseline in CMP laboratory values with units of mL/min/1.73m\^2.

  Baseline (Week 0), Week 24, and End of Study (Week 52)

• Laboratory Values. CMP (mmol/L)

  Changes from baseline in CMP laboratory values with units of mmol/L.

  Baseline (Week 0), Week 24, and End of Study (Week 52)

• Laboratory Values. CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))

  Changes from baseline in CMP laboratory values with units of Ratio: Albumin(g/dL) to Calc. Globulin(g/dL)

  Baseline (Week 0), Week 24, and End of Study (Week 52)

• Laboratory Values. CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))

  Changes from baseline in CMP laboratory values with units of Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL)

  Baseline (Week 0), Week 24, and End of Study (Week 52)

• Laboratory Values. Coagulation Panel (Seconds)

  Changes from baseline in Coagulation Panel values with units of seconds.

  Baseline (Week 0), Week 24, and End of Study (Week 52)

• Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))

  Changes from baseline in Coagulation laboratory values with units of Ratio: Prothrombin time (seconds) / Mean normal prothrombin time (seconds).

  Baseline (Week 0), Week 24, and End of Study (Week 52)

• Vital Signs. - Respiratory Rate (Breaths Per Minute)

  Changes from Baseline in Respiratory Rate.

  Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

• Vital Signs. - Heart Rate (Beats Per Minute)

  Change from baseline in Heart Rate.

  Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

• Vital Signs. - Body Temperature (Celsius )

  Change from baseline in Body Temperature.

  Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Secondary Outcomes (21)

• Change From Baseline in MDS-UPDRS Part I.

  Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

• Change From Baseline in MDS-UPDRS Part III.

  Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

• Change From Baseline in MDS-UPDRS Part IV.

  Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

• Change From Baseline in Neuro-QOL. - Communication

  Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

• Change From Baseline in Neuro-QOL. - Social Roles and Activities

  Baseline through Week 32, Follow-up at week 42 and End of Study at week 52

Study Arms (2)

HB-adMSCs

ACTIVE COMPARATOR

Autologous Hope Biosciences adipose derived mesenchymal stem cells.

Biological: HB-adMSCs; Other: Placebo

Placebo

PLACEBO COMPARATOR

Sterile Saline Solution 0.9%

Biological: HB-adMSCs; Other: Placebo

Interventions

HB-adMSCs BIOLOGICAL

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

Also known as: Autologous Hope Biosciences adipose derived mesenchymal stem cells.

HB-adMSCs; Placebo

Placebo OTHER

Placebo will be administered intravenously to study participants who qualify.

Also known as: Sterile Saline Solution 0.9%

HB-adMSCs; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants 18 - 75 years of age.
• Study participant must have been diagnosed with early and/or moderate Parkinson's disease at least 6 months before study participation.
• Study participants must have previously banked their mesenchymal stem cells with Hope Biosciences.
• Study participants should be able to read, understand and to provide written consent.
• Voluntarily signed informed consent obtained before any clinical-trial related procedures are performed.
• Female study participants should not be pregnant or plan to become pregnant during study participation and for 6 months after last investigational product administration.
• 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.
• Study participant is able and willing to comply with the requirements of this clinical trial.

You may not qualify if:

• Pregnancy, lactation. Women of childbearing age who are not pregnant but do not take effective contraceptive measures.
• Study participants with advanced Parkinson's disease described as, severe disability, wheelchair bound or bedridden.
• Study participant has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma or melanoma.
• Study participant has known alcoholic addiction or dependency or has current substance use or abuse.
• 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.
• 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.
• 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.
• Study participant has a laboratory abnormality during screening, including the following:

Sponsors & Collaborators

• Hope Biosciences Research Foundation: lead

Study Sites (1)

Hope Biosciences Stem Cell Research Foundation

Sugar Land, Texas, 77478, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Ridhima Vij, PhD
• Organization: Hope Biosciences Research Foundation

ridhima@hopebio.org

346-900-0340

Study Officials

• Djamchid Lotfi, MD

  Hope Biosciences Stem Cell Research Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study subjects, investigators and study staff will be blinded to the assigned treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A parallel study is a type of clinical study where two groups of treatments, A (HB-adMSCs) and B (Placebo), are given so that one group receives only A while another group receives only B.

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 16, 2021
• Study Start: June 28, 2021
• Primary Completion: February 6, 2023
• Study Completion: February 6, 2023
• Last Updated: April 15, 2026
• Results First Posted: May 20, 2024

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)