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Phase 2 Completed N=24 Randomized Quadruple-blind Treatment

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

Parkinson's Disease
Source: ClinicalTrials.gov NCT04928287 ↗
Enrolled (actual)
24
Serious AEs
4.2%
Results posted
May 2024
Primary outcomePrimary: Change From Baseline in MDS-UPDRS Part II. — 10.00; 7.33; -1.87; 0.11 score on a scale (52 points total)

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in MDS-UPDRS Part II.		 10.00; 7.33; -1.87; 0.11; -2.07; -1.56 —
PRIMARY
Laboratory Values. CBC (% of WBC)		 0.73; 0.87; 0.05; 0.27; 0.29; 0.16 —
PRIMARY
Laboratory Values. CBC (10^9 Cells/L)		 243.3; 209.4; 9.1; -12.1; 8.1; 0.8 —
PRIMARY
Laboratory Values. CBC (10^12 Cells/L)		 4.425; 4.723; 0.021; 0.129; 0.109; 0.024 —
PRIMARY
Laboratory Values. CBC (pg)		 30.80; 30.08; 0.01; -0.12; -0.06; -0.32 —
PRIMARY
Laboratory Values. CBC (fL)		 90.83; 88.30; -0.85; -0.46; 0.12; 0.53 —
PRIMARY
Laboratory Values. CBC (g/dL)		 33.89; 34.03; 0.34; 0.06; -0.07; -0.54 —
PRIMARY
Laboratory Values. CBC (% Difference in Volume and Size of RBC)		 12.39; 12.64; 0.33; 0.68; 0.16; 0.22 —
PRIMARY
Laboratory Values. CBC (% of Total Blood Cell Count)		 40.01; 41.63; -0.15; 0.91; 1.13; 0.44 —
PRIMARY
Vital Signs. - Blood Pressure (mmHg)		 129.0; 135.6; -1.9; -8.7; -5.9; -6.3 —
PRIMARY
Weight in kg.		 79.65; 78.94; 0.43; 0.33; 1.75; 0.44 —
PRIMARY
Laboratory Values. CMP (mg/dL)		 0.46; 0.46; 0.03; 0.10; 0.05; 0.09 —
PRIMARY
Laboratory Values. CMP (g/dL)		 4.51; 4.53; -0.03; 0.08; -0.01; -0.04 —
PRIMARY
Laboratory Values. CMP (IU/L)		 63.9; 75.7; 2.3; 3.7; 2.3; -0.1 —
PRIMARY
Laboratory Values. CMP (mL/Min/1.73m^2)		 80.7; 81.9; 4.6; 5.7; 6.4; 9.9 —
PRIMARY
Laboratory Values. CMP (mmol/L)		 104.5; 104.4; 0.5; -2.0; -0.3; -0.1 —
PRIMARY
Laboratory Values. CMP (Ratio: Albumin (g/dL) to Calc. Globulin (g/dL))		 1.75; 1.96; 0.03; -0.03; 0.02; 0.03 —
PRIMARY
Laboratory Values. CMP (Ratio: Urea Nitrogen (mg/dL) to Creatinine (mg/dL))		 18.5; 18.0; 1.1; 1.1; 0.8; 4.4 —
PRIMARY
Laboratory Values. Coagulation Panel (Seconds)		 13.20; 13.22; 0.07; -0.08; 0.13; -0.08 —
PRIMARY
Laboratory Values. Coagulation Panel (Ratio: Prothrombin Time (Seconds) / Mean Normal Prothrombin Time (Seconds))		 0.97; 0.96; 0.01; 0.02; 0.01; -0.00 —
PRIMARY
Vital Signs. - Respiratory Rate (Breaths Per Minute)		 16.3; 16.0; 0; 0.2; 0.1; 0.2 —
PRIMARY
Vital Signs. - Heart Rate (Beats Per Minute)		 70.7; 69.8; -1.3; 1.9; -2.1; 0.4 —
PRIMARY
Vital Signs. - Body Temperature (Celsius )		 36.59; 36.54; 0.09; -0.03; -0.02; -0.11 —
SECONDARY
Change From Baseline in MDS-UPDRS Part I.		 8.73; 6.78; -1.47; 0.33; -1.67; -0.33 —
SECONDARY
Change From Baseline in MDS-UPDRS Part III.		 26.27; 20.56; -5.33; -0.33; -8.33; -1.78 —
SECONDARY
Change From Baseline in MDS-UPDRS Part IV.		 2.67; 3.56; -0.67; -0.33; -0.87; -0.44 —
SECONDARY
Change From Baseline in Neuro-QOL. - Communication		 22.87; 21.78; 0.40; 2.00; 0.53; 1.33 —
SECONDARY
Change From Baseline in Neuro-QOL. - Social Roles and Activities		 36.00; 35.22; 0.93; 1.00; 0.47; 1.22 —
SECONDARY
Changes From Baseline in Neuro-QOL. - Anxiety		 17.87; 14.11; -1.40; -1.00; -2.40; -1.44 —
SECONDARY
Change From Baseline in Neuro-QOL. - Depression		 12.40; 9.89; -2.27; 0.11; -2.00; -0.11 —
SECONDARY
Change From Baseline in Neuro-QOL. - Dyscontrol		 13.47; 10.89; -0.33; -0.11; -1.07; -0.67 —
SECONDARY
Changes From Baseline in Neuro-QOL. - Fatigue		 16.67; 14.11; -1.73; 0.11; -1.67; -1.11 —
SECONDARY
Change From Baseline in Neuro-QOL. - Mobility		 37.00; 38.22; -0.53; 0.33; -0.33; 0.22 —
SECONDARY
Change From Baseline in Neuro-QOL. - Well-Being		 36.87; 39.00; 3.00; -1.22; 2.73; 0.33 —
SECONDARY
Change From Baseline in Neuro-QOL. - Sleep		 16.20; 14.33; -2.33; -1.89; -1.73; -1.89 —
SECONDARY
Change From Baseline in Neuro-QOL. - Fine Motor		 36.07; 37.33; 0.80; 1.67; 0.47; 1.11 —
SECONDARY
Change From Baseline in Neuro-QOL. - Stigma		 12.33; 12.00; -1.20; -1.22; -0.67; -1.44 —
SECONDARY
Change From Baseline in Neuro-QOL. - Social Roles		 30.47; 33.78; 3.27; 1.22; 2.87; 1.89 —
SECONDARY
Change From Baseline in Neuro-QOL. - Cognition		 33.47; 33.67; 2.53; 1.44; 1.33; 0.89 —
SECONDARY
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16).		 37.20; 34.11; -0.73; -8.33; 0.20; -4.33 —
SECONDARY
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39).		 28.13; 18.67; -4.87; -2.78; -4.67; -4.33 —
SECONDARY
Change From Baseline in Total Visual Analog Scale		 35.93; 19.89; -5.33; 2.89; -8.27; -3.33 —
SECONDARY
Change From Baseline in Dosage of Carbidopa/Levodopa		 439.3; 285.6; 0; 0; 0; 0 —
SECONDARY
Change From Baseline in Vital Signs. - Oxygen Saturation.		 97.8; 97.6; -0.2; -1.0; 0.2; 0.6 —

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • A study participant will not be eligible for inclusion in this clinical trial if any of the following criteria apply:
  • 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 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:
  • 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
  • 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.
  • Study participant is unlikely to complete the study or adhere to the study procedures.
  • Study participant with known concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection.
  • Study participant has a previously diagnosed psychiatric condition which in the opinion of the investigator may affect self-assessments.
  • Study participant with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product.
  • Male study participant
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04928287). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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