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HBPD04: Clinical Trial for Parkinson's Disease Using Allogeneic HB-adMSCs (Early and Moderate) (PD)

Sponsor
Hope Biosciences Stem Cell Research Foundation (Other)
Overall Status
Recruiting
CT.gov ID
NCT04995081
Collaborator
Hope Biosciences (Industry)
60
Enrollment
1
Location
2
Arms
24.1
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

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 60 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Biological/Vaccine: Allogeneic HB-adMSCs
  • Other: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Study subjects, investigators and study staff will be blinded to the assigned treatment.
Primary Purpose:
Treatment
Official Title:
"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"
Actual Study Start Date :
Jul 16, 2021
Anticipated Primary Completion Date :
Jul 20, 2023
Anticipated Study Completion Date :
Jul 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Allogeneic HB-adMSCs.

Biological/Vaccine: Allogeneic HB-adMSCs Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify. Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.

Biological: Biological/Vaccine: Allogeneic HB-adMSCs
HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names:
  • Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.

    • Other: Placebo
    Sterile Saline Solution 0.9%
    Other Names:
  • Placebo will be administered intravenously to study participants who qualify.

    		•
    Placebo Comparator: Placebo

    Placebo will be administered intravenously to study participants who qualify. Other Names: Sterile Saline Solution 0.9%

    Biological: Biological/Vaccine: Allogeneic HB-adMSCs
    HB-adMSCs will be administered intravenously to study participants who qualify.
    Other Names:
  • Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.

    • Other: Placebo
    Sterile Saline Solution 0.9%
    Other Names:
  • Placebo will be administered intravenously to study participants who qualify.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 1. Changes in the total score MDS-UPDRS Part II. [Baseline to Weeks 52.]

      Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II.

    2. 2. Incidence of treatment-emergent Adverse Event (TEAEs). [Baseline to Weeks 52.]

      Treatment-emergent Adverse Event.

    3. 3. Incidence of treatment-emergent Serious Adverse Events (SAEs). [Baseline to Weeks 52.]

      SSAEs.

    4. 4. AEs of special interest (serious or non-serious) - thromboembolic events. [Baseline to Weeks 52.]

      Incidence of thromboembolic events.

    5. 5. AEs of special interest (serious or non-serious) - thromboembolism of the extremities [Baseline to Weeks 52.]

      Incidence and risk of AEs of special interest (serious or non-serious), including peripheral events defined as, thromboembolism of the extremities.

    6. 6. AEs of special interest (serious or non-serious) - infections [Baseline to Weeks 52.]

      Incidence and risk of AEs of special interest (serious or non-serious), including infections.

    7. 7. AEs of special interest (serious or non-serious) - hypersensitivities. [Baseline to Weeks 52.]

      Incidence and risk of AEs of special interest (serious or non-serious), including hypersensitivities.

    8. 8. Laboratory value Complete Blood Count (CBC) [Baseline to Weeks 52.]

      Clinically significant changes in CBC values.

    9. 9. Laboratory values Chemistry Metabolic Panel (CMP) [Baseline to Weeks 52.]

      Number of Participants with changes in Laboratory CMP values

    10. 10. Laboratory values Coagulation Panel; Prothrombin time, Partial Prothrombin time, and INtern [Baseline to Weeks 52.]

      Number of Participants with changes in Laboratory Coagulation Panel values.

    11. 11. Vital signs. - Respiratory Rate (breaths per minute) [Baseline to Weeks 52.]

      Number of Participants with Clinically significant changes in Respiratory Rate.

    12. 12. Vital signs. - Heart Rate (beats per minute) [Baseline to Weeks 52.]

      Number of Participants with Clinically significant changes in Heart Rate.

    13. 13. Vital signs. - Body Temperature (Fahrenheit ) [Baseline to Weeks 52.]

      Number of participants with Clinically significant changes in Heart Rate.

    14. 14. Vital signs. - Blood Pressure (mmHg) [Baseline to Weeks 52.]

      Number of Participants with Clinically significant changes in Blood Pressure.

    15. 15. Weight in lb. [Baseline to Weeks 52.]

      Number of Participants with Clinically significant changes in Weight in lb.

    16. 16. Physical examination results. General [Baseline to Weeks 52.]

      Number of Participants with Clinically significant changes in general physical examination results.

    17. 17. Physical examination results. Body Systems. [Baseline to Weeks 52.]

      Number of Participants with Clinically significant changes in body systems physical examination results.

    Secondary Outcome Measures

    1. 18. Changes in Movement Disorder Society Unified Parkinson's Disease Rating Scale -UPDRS Part I. [Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.]

      Changes in MDS-UPDRS Part I

    2. 19. Changes in the total score Movement Disorder Society Unified Parkinson's Disease Rating Scale -UPDRS Part II and Part III. [Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.]

      Changes in Total score MDS-UPDRS Part II and Part III

    3. 20. Changes in Movement Disorder Society Unified Parkinson's Disease Rating Scale MDS-UPDRS Part III. [Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.]

      Changes in MDS-UPDRS Part III

    4. 21. Changes in Movement Disorder Society Unified Parkinson's Disease Rating Scale MDS-UPDRS Part IV. [Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.]

      Changes in MDS-UPDRS Part IV

    5. 22. Changes in Short Form 36 Health Survey Questionnaire (SF-36). [Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.]

      Changes in SF-36

    6. 23. Changes in Parkinson's disease fatigue scale (PFS-16) [Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.]

      Improvements in Participants PFS-16 scores

    7. 24. Changes in Parkinson's disease Questionnaire (PDQ-39). [Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.]

      Improvements in Participants PDQ-39 scores

    8. 25. Changes in Visual Analog Scale for Pain. [Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.]

      Changes in Participants VAS Pain Scales

    9. 26. Changes in Visual Analog Scale for Muscle spasms. [Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.]

      Changes in Participants VAS spasms Scale

    10. 27. Changes in Dosage of medications taken to treat Parkinson's disease. [Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.]

      Changes in Participants medications taken

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    1. 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.

    2. 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.

    3. 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

    1. 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.

    2. Study participant is unlikely to complete the study or adhere to the study procedures.

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

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

    5. Study participant with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product.

    6. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hope Biosciences Stem Cell Research Foundation Sugar Land Texas United States 77478

    Sponsors and Collaborators

    • Hope Biosciences Stem Cell Research Foundation
    • Hope Biosciences

    Investigators

    • Principal Investigator: Djamchid Lotfi, MD, Hope Biosciences Stem Cell Research Foundation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hope Biosciences Stem Cell Research Foundation
    ClinicalTrials.gov Identifier:
    NCT04995081
    Other Study ID Numbers:
    • HBPD04
    First Posted:
    Aug 6, 2021
    Last Update Posted:
    Aug 6, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of Aug 6, 2021