Diagnosed with Parkinson'
Conditions
Interventions
All PD patients meeting the inclusion criteria received four injections within one month, once a week, using combined intravenous and intrathecal infusion therapy. In week 1, patients received intrave
Experimental Other,Experimental Other
Home-based Rehabilitation Exercise Combined with Mesenchymal Stem Cell Injection Group,Mesenchymal Stem Cell Injection Group
Sponsors
Zibo 148 Hospital
Shandong Sport University
Eligibility
Sex/Gender
All
Age
45 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age of 18 to 85 years , male or female. 2. Patients with idiopathic Parkinson' disease meeting the diagnostic criteria for Parkinson' disease in China, with other neurodegenerative diseases excluded. 3. Presence of motor complications and unsatisfactory drug control after standardized pharmacological treatment. 4. No severe viral or bacterial infection. 5. Doppler echocardiographic assessment: left ventricular ejection fraction (LVEF) greater than or equal to the lower limit of normal (50%). 6. Stable disease, well-controlled complications, no contraindications to anesthesia, no contraindications to stereotactic surgery, and no other conditions that would interfere with clinical evaluation. 7.Serum levels of calcium, potassium, and magnesium within the normal reference range. 8. ECOG performance status score 0 to 2. 9. No evidence of acute inflammatory infection on chest CT. 10. Hematological tests within 1 week before treatment meet the following criteria (no blood products or cell growth factors permitted within 14 days before screening). 11. No hemorrhagic disorders or coagulation dysfunction. 12. For women of childbearing potential who are not surgically sterilized:a medically accepted contraceptive method (e.g., intrauterine device [IUD], oral contraceptives, condoms) must be used during study treatment and for 3 months after completion of study treatment.Serum or urine HCG test must be negative within 7 days before enrollment.Patients must be non-lactating.Women who have undergone sterilization or have been postmenopausal for at least 2 years are considered non-fertile. 13. The subject voluntarily participates in this study and signs the informed consent form, with good compliance and willingness to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Unable to understand the purpose of the study and or the protocol procedures. 2. Atypical Parkinson's disease, such as Parkinsonism or secondary Parkinson's disease. 3. Any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism). Patients with vitiligo or childhood asthma that has been in complete remission without adult intervention may be included. Patients with asthma requiring medical intervention with bronchodilators are not eligible. 4. Known or suspected allergy or severe adverse reaction to any component of the investigational product, or patients with allergic constitution. 5. Coagulation dysfunction. 6. Subjects with clinically symptomatic central nervous system metastases (e.g., cerebral edema requiring hormonal intervention, or progressive brain metastases). 7. Patients who received cytotoxic therapy within the last 3 months prior to enrollment; use of probiotics, antibiotics, or nonsteroidal anti-inflammatory drugs within 3 months before fecal sample collection. 8. Presence of any of the following cardiovascular or cerebrovascular conditions: Clinically significant cardiac disease within 6 months prior to enrollment, including congestive heart failure greater than or equal to New York Heart Association Class II-IV, unstable angina (angina at rest), new-onset angina (within 3 months before enrollment), or myocardial infarction; Ventricular arrhythmia requiring antiarrhythmic therapy; QTc greater than 470 ms; poorly controlled hypertension (systolic blood pressure greater than 150 mmHg or diastolic blood pressure greater than 100 mmHg); Thrombotic or embolic venous or arterial events within 6 months prior to enrollment, such as cerebrovascular accident including transient ischemic attack, stroke, arterial thrombosis, deep vein thrombosis, and pulmonary embolism. 9. Chronic unhealed wounds or fractures in the chest or other sites. 10. Previous receipt of any cell therapy. 11. Congenital or acquired immunodeficiency (e.g., HIV infection) or active hepatitis (hepatitis B: HBsAg positive; hepatitis C: anti-HCV positive with HCV RNA above the lower limit of detection). 12. Known history of psychoactive substance abuse, alcoholism, or drug addiction. 13. Pregnant or lactating women. 14. Participation in another clinical trial within 30 days prior to the start of study treatment. 15. In the investigator's judgment, any other factors that may lead to premature discontinuation of the study, such as other severe diseases (including psychiatric disorders) requiring concomitant treatment, severe abnormal laboratory findings, or social/family conditions that may compromise subject safety or interfere with the collection of study data and samples. 16. Severe cognitive impairment, depression, or behavioral disorder, defined as Mini-Mental State Examination (MMSE) score less than 26 or Hamilton Depression Rating Scale (HAMD) score greater than 35; or patients unable to understand and sign the informed consent form. 17. Presence of a concurrent malignancy or history of malignancy. 18. Primary gastrointestinal lesions; history of chronic gastrointestinal diseases including inflammatory bowel disease and celiac disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep Quality Baseline, 1 month, 3 months Pittsburgh Sleep Quality Index,Upper and lower limb muscle function Baseline, 1 month, 3 months Surface electromyography test and accelerometer,Walking ability Baseline, 1 month, 3 months Motion capture system,Quality of Life Baseline, 1 month, 3 months Patient Assessment of Constipation - Quality of Life, Barthel score,severity and progression of Parkinson's disease Baseline, 1 month, 3 months Unified Parkinson's Disease Rating Scale, Hoehn-Yahr score,balance function Baseline, 1 month, 3 months Berg Balance Scale,severity of gastrointestinal symptoms Baseline, 1 month, 3 months Gastrointestinal Symptom Rating Scale,severity of constipation symptoms Baseline, 1 month, 3 months Patient Assessment of Constipation Symptoms, Wexner Constipation Scoring System,function performance Baseline, 1 month, 3 months Five-Times-Sit-to-Stand Test, 5-Meter Walk Test , Timed Up and Go Test | — |
Secondary
| Measure | Time frame |
|---|---|
| severity of anxiety symptoms Baseline, 1 month, 3 months Hamilton Anxiety Rating Scale,severity of depressive symptoms Baseline, 1 month, 3 months Hamilton Depression Rating Scale | — |
Countries
China
Contacts
Public ContactYunliang Wang
Zibo148 Hospital
Outcome results
None listed