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;
Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd.
Lead sponsor