Clinical Research on Stem Cell Therapy for Parkinson's Disease
Sponsored by Liaoning Medical Diagnosis and Treatment Technology Research and Development Co., Ltd.
About this trial
Last updated 6 months ago
Study ID
LNMDTC
Status
Not yet recruiting
Type
Interventional
Phase
Phase 1
Placebo
No
Accepting
18 to 75 Years
All Sexes
Trial Timing
Started 5 months ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
The participants must meet all of the following criteria to be included in this study:
1. The participants must fully understand and comply with the research procedures, voluntarily participate in the study and sign the informed consent form;
2. 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;
3. 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);
4. 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;
5. During the screening, the score of the third part of the MDS-UPDRS in the "off" period must be greater than 30;
6. During the screening, the stable duration of Parkinson's disease and the stable duration of the optimized drug dosage must be at least 4 weeks, and the duration of levodopa use must be at least 1 year;
7. During the screening, the participants must have a response to levodopa treatment, and the levodopa loading test must be positive;
8. The participants must experience a decline in the efficacy of anti-Parkinson's disease treatment, which affects their quality of life;
9. The participants must have good compliance and be able to cooperate with the completion of the assessment items of the trial; For participants with reproductive potential and their partners, they must be free from pregnancy plans for at least 2 weeks before the screening to at least 1 year after the administration of the drug, and must agree to take effective non-drug contraceptive measures during the trial (such as condoms, non-drug intrauterine devices, etc.), except for those who have taken permanent contraceptive measures, such as bilateral tubal ligation, vasectomy, etc.
Exclusion Criteria
If the subjects meet any of the following criteria, they will not be included in this study:
1. 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);
2. Have a previous history of mental disorders, serious diseases, or other significant diseases that may affect safety;
3. 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;
4. Positive for hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab), or Treponema pallidum antibody positive;
5. Previously diagnosed with secondary or atypical Parkinson's syndrome caused by drugs, metabolic disorders, or other reasons;
6. Previously diagnosed with epilepsy, stroke, multiple sclerosis, poorly controlled or progressive neurological diseases;
7. Have new or unstable mental symptoms within 1 year before screening (such as mental confusion, severe depression, or tendencies towards self-harm/suicide);
8. Have a history of dementia or severe cognitive dysfunction; or have obvious dementia or cognitive dysfunction at screening; the 1.1 part of the MDS-UPDRS score at screening is > 3; due to dementia, the subject's compliance is affected, diary cannot be accurately recorded, and/or the informed consent cannot be signed;
9. Have other serious systemic diseases at the time of screening;
10. Have any history of malignant tumors in the past;
11. Are participating in other clinical trials, or have participated in other clinical studies within 3 months before administration and received intervention treatment;
12. Have active infections at the screening period, and still need systemic application of antibiotics, antifungal, antiviral treatment at baseline and the infection has not been controlled;
13. Have a history of stroke, unstable angina pectoris, or myocardial infarction attack within 6 months before screening;
14. Have a history of schizophrenia or other severe mental disorders, drug or alcohol abuse;
15. Pregnant or lactating women; Subjects deemed unsuitable for participation in the study by the investigator's comprehensive assessment.