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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04928287
Recruitment Status : Recruiting
First Posted : June 16, 2021
Last Update Posted : July 6, 2021
Sponsor:
Collaborator:
Hope Biosciences
Information provided by (Responsible Party):
Hope Biosciences ( Hope Biosciences Stem Cell Research Foundation )

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Biological: HB-adMSCs Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 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 (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 Autologous HB-adMSCs vs Placebo for the Treatment of Patients With Parkinson's Disease"
Actual Study Start Date : June 28, 2021
Estimated Primary Completion Date : May 28, 2023
Estimated Study Completion Date : May 28, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: HB-adMSCs
Autologous Hope Biosciences adipose derived mesenchymal stem cells.
Biological: HB-adMSCs
HB-adMSCs will be administered intravenously to study participants who qualify.
Other Name: Autologous Hope Biosciences adipose derived mesenchymal stem cells.

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

Placebo Comparator: Placebo
Sterile Saline Solution 0.9%
Biological: HB-adMSCs
HB-adMSCs will be administered intravenously to study participants who qualify.
Other Name: Autologous Hope Biosciences adipose derived mesenchymal stem cells.

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




Primary Outcome Measures :
  1. Changes in MDS-UPDRS Part II. [ Time Frame: Baseline to Weeks 52. ]
    MDS-UPDRS Part II.

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

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

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

  5. AEs of special interest (serious or non-serious) - thromboembolism of the extremities [ Time Frame: 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. AEs of special interest (serious or non-serious) - infections [ Time Frame: Baseline to Weeks 52. ]
    Incidence and risk of AEs of special interest (serious or non-serious), including infections.

  7. AEs of special interest (serious or non-serious) - hypersensitivities. [ Time Frame: Baseline to Weeks 52. ]
    Incidence and risk of AEs of special interest (serious or non-serious), including hypersensitivities.

  8. Laboratory values. CBC [ Time Frame: Baseline to Weeks 52. ]
    Clinically significant changes in CBC values.

  9. Laboratory values. CMP [ Time Frame: Baseline to Weeks 52. ]
    Clinically significant changes in CMP values.

  10. Laboratory values. Coagulation Panel [ Time Frame: Baseline to Weeks 52. ]
    Clinically significant changes in Coagulation Panel values.

  11. Vital signs. - Respiratory Rate (breaths per minute) [ Time Frame: Baseline to Weeks 52. ]
    Clinically significant changes in Respiratory Rate.

  12. Vital signs. - Heart Rate (beats per minute) [ Time Frame: Baseline to Weeks 52. ]
    Clinically significant changes in Heart Rate.

  13. Vital signs. - Body Temperature (Fahrenheit ) [ Time Frame: Baseline to Weeks 52. ]
    Clinically significant changes in Heart Rate.

  14. Vital signs. - Blood Pressure (mmHg) [ Time Frame: Baseline to Weeks 52. ]
    Clinically significant changes in Blood Pressure.

  15. Weight in lb. [ Time Frame: Baseline to Weeks 52. ]
    Clinically significant changes in Weight in lb.

  16. Physical examination results. General [ Time Frame: Baseline to Weeks 52. ]
    Clinically significant changes in general physical examination results.

  17. Physical examination results. Body Systems. [ Time Frame: Baseline to Weeks 52. ]
    Clinically significant changes in body systems physical examination results.


Secondary Outcome Measures :
  1. Changes in MDS-UPDS total score. [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    MDS-UPDS Parts I, II, III and IV.

  2. Changes in MDS-UPDRS Part I. [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue.

  3. Changes in MDS-UPDRS Part III. [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Motor Examination, including speech, facial expression, rigidity, finger tapping, hand movements, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement (body bradykinesia), postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage.

  4. Changes in MDS-UPDRS Part IV. [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Motor Complications, including time spent with dyskinesias and others.

  5. Changes in Neuro-QOL. - Communication [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Communication - Short Form

  6. Changes in Neuro-QOL. - Social Roles and Activities [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Ability to Participate in Social Roles and Activities - Short Form

  7. Changes in Neuro-QOL. - Anxiety [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Anxiety - Short Form

  8. Changes in Neuro-QOL. - Depression [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Depression - Short Form

  9. Changes in Neuro-QOL. - Dyscontrol [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Emotional and Behavioral Dyscontrol - Short Form

  10. Changes in Neuro-QOL. - Fatigue [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Fatigue - Short Form

  11. Changes in Neuro-QOL. - Mobility [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Lower Extremity Function (Mobility) - Short Form

  12. Changes in Neuro-QOL. - Well-Being [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Positive Affect and Well-Being - Short Form

  13. Changes in Neuro-QOL. - Sleep [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Sleep Disturbance - Short Form

  14. Changes in Neuro-QOL. - Fine Motor [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Upper Extremity Function (Fine Motor, ADL) - Short Form

  15. Changes in Neuro-QOL. - Stigma [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Stigma-Short Form

  16. Changes in Neuro-QOL. - Social Roles [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Satisfaction with Social Roles and Activities - Short Form

  17. Changes in Neuro-QOL. - Cognition [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Cognition Function- Short Form

  18. Changes in Parkinson's disease fatigue scale (PFS-16). [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Score of ≥8 indicates the presence of significant fatigue.

  19. Changes in Parkinson's disease Questionnaire (PDQ-39). [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Difficulties across the 8 quality of life dimensions of functioning of wellbeing.

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

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

  22. Incidence of treatment-emergent Adverse Event (TEAEs) and serious Adverse Events (SAEs). [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Adverse Event (TEAEs)

  23. Incidence and risk of AEs of special interest (serious or non-serious), [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Including thromboembolic events, peripheral events defined as, thromboembolism of the extremities, also infections and hypersensitivities.

  24. Clinically significant changes in laboratory values. - CBC [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    CBC

  25. Changes in Visual Analog Scale for muscle spasms. [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Visual Analog Scale for muscle spasms.

  26. Clinically significant changes in vital signs. - Respiratory Rate [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Changes in Respiratory Rate.

  27. Clinically significant changes in vital signs. - Heart Rate [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Changes in Heart Rate.

  28. Clinically significant changes in vital signs. - Body Temperature. [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Changes in Body Temperature.

  29. Clinically significant changes in vital signs. - Blood Pressure. [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Changes in Blood Pressure.

  30. Clinically significant changes in vital signs. - Oxygen Saturation. [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Changes in Oxygen Saturation.

  31. Clinically significant changes in physical examination results. [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Physical examination results.

  32. Clinically significant changes in weight in lb. [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Weight in lb.

  33. Clinically significant changes in laboratory values. - CMP [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    CMP

  34. Clinically significant changes in laboratory values. - Coagulation Panel [ Time Frame: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52. ]
    Coagulation Panel



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04928287


Contacts
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Contact: Sherry L Diers, RN 346-900-0340 ext 101 sherry@hopebio.org
Contact: David Gonzalez, RN 346-900-0340 ext 101 david@hopebio.org

Locations
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United States, Texas
Hope Biosciences Stem Cell Research Foundation Recruiting
Sugar Land, Texas, United States, 77478
Contact: Sherry L Diers, RN    346-900-0340 ext 101    sherry@hopebio.org   
Contact: David Gonzalez, RN    346-900-0340 ext 101    david@hopebio.org   
Principal Investigator: Djamchid Lotfi, MD         
Sub-Investigator: Thanh Cheng, MD         
Sponsors and Collaborators
Hope Biosciences Stem Cell Research Foundation
Hope Biosciences
Investigators
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Principal Investigator: Djamchid Lotfi, MD Hope Biosciences Stem Cell Research Foundation
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Responsible Party: Hope Biosciences Stem Cell Research Foundation
ClinicalTrials.gov Identifier: NCT04928287    
Other Study ID Numbers: HBPD03
First Posted: June 16, 2021    Key Record Dates
Last Update Posted: July 6, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases