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

20 juillet 2022 mis à jour par: Hope Biosciences Stem Cell Research Foundation

"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"

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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Anticipé)

24

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Texas
      • Sugar Land, Texas, États-Unis, 77478
        • Hope Biosciences Stem Cell Research Foundation

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: HB-adMSCs
Autologous Hope Biosciences adipose derived mesenchymal stem cells.
Biologique: HB-adMSCs
HB-adMSCs will be administered intravenously to study participants who qualify.
Autres noms:
  • Autologous Hope Biosciences adipose derived mesenchymal stem cells.
Autre: Placebo
Placebo will be administered intravenously to study participants who qualify.
Autres noms:
  • Sterile Saline Solution 0.9%
Comparateur placebo: Placebo
Sterile Saline Solution 0.9%
Biologique: HB-adMSCs
HB-adMSCs will be administered intravenously to study participants who qualify.
Autres noms:
  • Autologous Hope Biosciences adipose derived mesenchymal stem cells.
Autre: Placebo
Placebo will be administered intravenously to study participants who qualify.
Autres noms:
  • Sterile Saline Solution 0.9%

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Changes in MDS-UPDRS Part II.
Délai: Baseline to Weeks 52.
MDS-UPDRS Part II.
Baseline to Weeks 52.
Incidence of treatment-emergent Adverse Event (TEAEs).
Délai: Baseline to Weeks 52.
treatment-emergent Adverse Event.
Baseline to Weeks 52.
Incidence of treatment-emergent Serious Adverse Events (SAEs).
Délai: Baseline to Weeks 52.
SSAEs.
Baseline to Weeks 52.
AEs of special interest (serious or non-serious) - thromboembolic events.
Délai: Baseline to Weeks 52.
Incidence of thromboembolic events.
Baseline to Weeks 52.
AEs of special interest (serious or non-serious) - thromboembolism of the extremities
Délai: 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.
Baseline to Weeks 52.
AEs of special interest (serious or non-serious) - infections
Délai: Baseline to Weeks 52.
Incidence and risk of AEs of special interest (serious or non-serious), including infections.
Baseline to Weeks 52.
AEs of special interest (serious or non-serious) - hypersensitivities.
Délai: Baseline to Weeks 52.
Incidence and risk of AEs of special interest (serious or non-serious), including hypersensitivities.
Baseline to Weeks 52.
Laboratory values. CBC
Délai: Baseline to Weeks 52.
Clinically significant changes in CBC values.
Baseline to Weeks 52.
Laboratory values. CMP
Délai: Baseline to Weeks 52.
Clinically significant changes in CMP values.
Baseline to Weeks 52.
Laboratory values. Coagulation Panel
Délai: Baseline to Weeks 52.
Clinically significant changes in Coagulation Panel values.
Baseline to Weeks 52.
Vital signs. - Respiratory Rate (breaths per minute)
Délai: Baseline to Weeks 52.
Clinically significant changes in Respiratory Rate.
Baseline to Weeks 52.
Vital signs. - Heart Rate (beats per minute)
Délai: Baseline to Weeks 52.
Clinically significant changes in Heart Rate.
Baseline to Weeks 52.
Vital signs. - Body Temperature (Fahrenheit )
Délai: Baseline to Weeks 52.
Clinically significant changes in Heart Rate.
Baseline to Weeks 52.
Vital signs. - Blood Pressure (mmHg)
Délai: Baseline to Weeks 52.
Clinically significant changes in Blood Pressure.
Baseline to Weeks 52.
Weight in lb.
Délai: Baseline to Weeks 52.
Clinically significant changes in Weight in lb.
Baseline to Weeks 52.
Physical examination results. General
Délai: Baseline to Weeks 52.
Clinically significant changes in general physical examination results.
Baseline to Weeks 52.
Physical examination results. Body Systems.
Délai: Baseline to Weeks 52.
Clinically significant changes in body systems physical examination results.
Baseline to Weeks 52.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Changes in MDS-UPDS total score.
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
MDS-UPDS Parts I, II, III and IV.
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in MDS-UPDRS Part I.
Délai: 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.
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in MDS-UPDRS Part III.
Délai: 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.
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in MDS-UPDRS Part IV.
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Motor Complications, including time spent with dyskinesias and others.
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Neuro-QOL. - Communication
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Communication - Short Form
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Neuro-QOL. - Social Roles and Activities
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Ability to Participate in Social Roles and Activities - Short Form
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Neuro-QOL. - Anxiety
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Anxiety - Short Form
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Neuro-QOL. - Depression
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Depression - Short Form
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Neuro-QOL. - Dyscontrol
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Emotional and Behavioral Dyscontrol - Short Form
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Neuro-QOL. - Fatigue
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Fatigue - Short Form
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Neuro-QOL. - Mobility
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Lower Extremity Function (Mobility) - Short Form
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Neuro-QOL. - Well-Being
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Positive Affect and Well-Being - Short Form
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Neuro-QOL. - Sleep
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Sleep Disturbance - Short Form
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Neuro-QOL. - Fine Motor
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Upper Extremity Function (Fine Motor, ADL) - Short Form
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Neuro-QOL. - Stigma
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Stigma-Short Form
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Neuro-QOL. - Social Roles
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Satisfaction with Social Roles and Activities - Short Form
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Neuro-QOL. - Cognition
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Cognition Function- Short Form
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Parkinson's disease fatigue scale (PFS-16).
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Score of ≥8 indicates the presence of significant fatigue.
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Parkinson's disease Questionnaire (PDQ-39).
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Difficulties across the 8 quality of life dimensions of functioning of wellbeing.
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Visual Analog Scale for Pain.
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Visual Analog Scale for Pain.
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Dosage of medications taken to treat Parkinson's disease.
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Dosage of medications.
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Incidence of treatment-emergent Adverse Event (TEAEs) and serious Adverse Events (SAEs).
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Adverse Event (TEAEs)
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Incidence and risk of AEs of special interest (serious or non-serious),
Délai: 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.
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Clinically significant changes in laboratory values. - CBC
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
CBC
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Visual Analog Scale for muscle spasms.
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Visual Analog Scale for muscle spasms.
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Clinically significant changes in vital signs. - Respiratory Rate
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Respiratory Rate.
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Clinically significant changes in vital signs. - Heart Rate
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Heart Rate.
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Clinically significant changes in vital signs. - Body Temperature.
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Body Temperature.
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Clinically significant changes in vital signs. - Blood Pressure.
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Blood Pressure.
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Clinically significant changes in vital signs. - Oxygen Saturation.
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Changes in Oxygen Saturation.
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Clinically significant changes in physical examination results.
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Physical examination results.
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Clinically significant changes in weight in lb.
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Weight in lb.
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Clinically significant changes in laboratory values. - CMP
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
CMP
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Clinically significant changes in laboratory values. - Coagulation Panel
Délai: Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.
Coagulation Panel
Baseline to Weeks 4, 8, 16, 24, 32, 42 and 52.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hope Biosciences Stem Cell Research Foundation

Collaborateurs

Hope Biosciences

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

28 juin 2021

Achèvement primaire (Anticipé)

28 mai 2023

Achèvement de l'étude (Anticipé)

28 mai 2023

Dates d'inscription aux études

Première soumission

26 mai 2021

Première soumission répondant aux critères de contrôle qualité

14 juin 2021

Première publication (Réel)

16 juin 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

21 juillet 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 juillet 2022

Dernière vérification

1 juillet 2022

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HBPD03

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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