This study, through different administration methods, adopted a randomized, double-blind, placebo-controlled trial design to evaluate the safety and tolerability of human umbilical cord mesenchymal stem cells (hUC-MSCs) in patients with Parkinson's disease, explore their initial effectiveness and the relationship between biological active factors and therapeutic efficacy. The "Clinical Study on the Treatment of Parkinson's Disease with Human Umbilical Cord Mesenchymal Stem Cells" of this study is expected to provide clinical trial evidence for the development of safe and effective clinical cell therapies for patients with Parkinson's disease.
The participants must fully understand and comply with the research procedures, voluntarily participate in the study and sign the informed consent form;
At the time of signing the informed consent, the participants must be aged 18 or above and under 75 years old, with no gender restrictions;
During the screening process, the participants must have had primary Parkinson's disease for at least 5 years, have a confirmed medical history record and meet the diagnostic criteria for primary Parkinson's disease as defined by the International Parkinson and Movement Disorder Society (MDS);
During the screening, according to the MDS-UPDRS scoring scale, the Hoehn-Yahr classification of the "off" period of drug treatment is 2 to 4;
Allergic to the study drug or its excipients, or allergic to similar drugs of the study drug, or have a history of severe allergies (including any food allergy or drug allergy);
Have a previous history of mental disorders, serious diseases, or other significant diseases that may affect safety;
Have a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive), or acquired immunodeficiency syndrome-related diseases, or positive HIV serological test results;
Positive for hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab), or Treponema pallidum antibody positive;
Single group
Human-derived stromal cells
Biological/VaccineThe human-derived stromal cells were administered intravenously once every two weeks, for a total of 5 times. Among them, half of the subjects (10 people) received intranasal administration of human-derived stromal cells once a day, in the morning and evening, from the 6th to the 8th day after each administration; the remaining subjects (10 people) received nasal administration of placebo once a day, in the morning and evening, from the 6th to the 8th day after each administration.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
The safety and tolerability of hUC-MSCs will be assessed by monitoring the frequency of all adverse events (AEs) and serious adverse events (SAEs). Measure: Number of participants with AEs and SAEs
Severity of Adverse Events
Severity of AEs and SAEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Measure: Grade on NCI-CTCAE v5.0 scale
Safety Assessments: Vital Signs
Changes in vital signs including body temperature, heart rate, blood pressure, and oxygen saturation. Measure: Number of participants with clinically significant changes in vital signs
Safety Assessments: Laboratory Parameters
Changes in laboratory tests including complete blood count, coagulation profile, liver and kidney function, BNP, D-dimer, and serum troponin. Measure: Number of participants with clinically significant abnormal laboratory values
Change in Motor Function as Assessed by MDS-UPDRS Part III
Change in severity of motor symptoms (e.g., tremor, rigidity, bradykinesia) using the MDS-UPDRS Part III score. Measure: Score on MDS-UPDRS Part III
Change in Disease Staging as Assessed by Hoehn & Yahr Staging
Change in disease stage using the Hoehn \& Yahr Staging scale. Measure: Stage on Hoehn \& Yahr scale
Change in Non-Motor Symptoms as Assessed by NMSS
Change in non-motor symptoms using the Non-Motor Symptoms Scale (NMSS). Measure: Score on NMSS
Change in Depressive Symptoms as Assessed by HAMD
Change in depressive symptoms using the Hamilton Depression Rating Scale (HAMD). Measure: Score on HAMD
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
