Neurodegenerative Diseases
Conditions
Interventions
Parkinson’s Disease Group A (Stem Cell Therapy):intravenous injection of stem cells
Parkinson’s Disease Group B (Conventional Therapy):Standard Clinical Management of Parkinson's Disease
Alzheimer’s Disease Group C (Stem Cell Therapy):intravenous injection of stem cells
Alzheimer’s Disease Group D (Conventional Therapy):Standard Clinical Management of Alzheimer’s Disease
Sponsors
Central Theater Command General Hospital
Eligibility
Sex/Gender
All
Age
45 Years to 85 Years
Inclusion criteria
Inclusion criteria: Parkinson's disease (PD) clinical trial inclusion criteria: 1.Diagnostic criteria: meet the clinical diagnostic criteria for PD issued by the International Parkinson and Movement Disorders Society (MDS) in 2015, and confirmed by a neurologist specialist. 2. Age range: 45-85 years old (including borderline values). 3. Disease stage: Hoehn-Yahr stage 1-4 (mild to severe), and stable immune function (no history of immunosuppressive therapy, no combined immunodeficiency diseases). 4. Informed consent: the patient or his/her legal guardian will sign a written informed consent form. 5. Adherence requirements: It is expected that the patient will be able to complete at least 12 months of follow-up and efficacy assessment (e.g. motor function scale, non-motor symptom questionnaire, etc.). Inclusion criteria for Parkinson's disease control group: 1. Diagnostic criteria: meet the clinical diagnostic criteria for PD issued by the International Parkinson and Movement Disorders Society (MDS) in 2015, and confirmed by a neurologist specialist. 2. Age: the age difference between the patients in the test group and the patients in the test group was =5 years. 3. Disease severity: the difference between the Hoehn-Yahr stage and the test group was =0.5 stages. 4. Duration of the disease: the difference in the duration of PD diagnosis with the test group is =1 year. 5. Sex ratio: the ratio of male to female is the same as that of the experimental group. 6. Receive standardised conventional clinical treatment: use only basic PD medications recommended by guidelines (e.g. levodopa preparations, dopamine agonists, MAO-B inhibitors, etc.) and prohibit experimental interventions: exclude non-pharmacological treatments, such as stem cell therapy, gene therapy, and neuromodulation surgery (e.g., DBS), and have not adjusted the core treatment regimen in the last 3 months prior to enrolment (e.g., isoelectric dosage of levodopa changed by <20%). <20%). Inclusion criteria for Alzheimer's disease (AD) clinical trials: 1. Meet the NIA-AA diagnostic criteria. 2; 2. MMSE score of 10-24; 3. Age 50-80 years old; 4. Signed informed consent; 5. Good compliance; Inclusion criteria for Alzheimer's disease control group: 1. Diagnostic criteria: meeting the NIA-AA diagnostic criteria and MMSE score of 10~24. 2. 2. Age: the difference in age between patients in the test group and those in the control group is less than 5 years. 3. Disease duration: the difference between the duration of AD diagnosis and the test group is less than 1 year. 4. 4. Sex ratio: the ratio of men and women is the same as that of the experimental group. 5. Receive standardised conventional clinical treatment: only use basic AD treatment drugs recommended by guidelines (e.g., amantadine, etc.), and prohibit experimental interventions: exclude non-pharmacological treatments such as stem cell therapy and gene therapy.
Exclusion criteria
Exclusion criteria: Parkinson's disease (PD) clinical trial exclusion criteria: 1. History of cell therapy: previous systemic or local autologous/allogeneic stem cell therapy (including haematopoietic stem cells, mesenchymal stem cells, etc.). 2. History of allergy: a clear history of allergy to any component of stem cell therapy products (e.g., animal-derived serum, antibiotics, human albumin, etc.). 3. Serious comorbidities: e.g. congestive heart failure, myocardial infarction, respiratory failure, uncontrolled diabetes mellitus, severe hepatic or renal insufficiency. 4. Malignant tumour: current malignant tumour, or previous history of malignant tumour. 5. Overlapping clinical trials: participation in other interventional clinical trials (except observational studies) within the last 1 year. 6. Diseases interfering with assessment: Comorbid neurological diseases such as Alzheimer's disease, multiple sclerosis, etc. that may affect the assessment of motor/non-motor symptoms in PD. 7. Other: Special conditions that, in the judgement of the investigator, may interfere with the assessment of efficacy or increase the safety risk (e.g., history of fractures due to frequent falls, uncontrolled psychiatric disorders, etc.). Parkinson's Disease Control Group Exclusion Criteria: Share all exclusion criteria with the trial group (i.e., no history of cell therapy, no history of allergy to stem cell components, no serious comorbidities/malignancies/other neurological disorders, no participation in other clinical trials in the last 1 year, etc.). Alzheimer's disease (AD) clinical trial exclusion criteria: 1. Having malignant tumour or previous history of malignant tumour; 2. Combination of serious complications, such as congestive heart failure, myocardial infarction, respiratory failure, uncontrolled diabetes mellitus, severe liver and kidney insufficiency, etc. Insufficiency of liver and kidney, etc; 3. Infectious diseases or previous history of infectious diseases; 4. Comorbidities with other neurological diseases, such as Parkinson's disease, multiple sclerosis, etc., which may interfere with the diagnosis of AD and the assessment of treatment effects; 5. Rapidly progressive AD; 6. Allergy to stem cell therapy products; 7. Previous similar treatment: e.g. stem cell therapy or other experimental treatment. Alzheimer's disease control group exclusion criteria: Share all exclusion criteria with the experimental group (i.e., no history of cell therapy, no history of allergy to stem cell components, no serious comorbidities/malignancies/other neurological diseases, no participation in other clinical trials in the last 1 year, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of clinical symptoms;UPDRS score;Hoehn-Yahr Staging Scale;IL-6;TNF-a;IL-10;IL-4;TGF-ß;BDNF;Structural MRI;MMSE score;ADAS-Cog score;p-tau; | — |
Countries
China
Contacts
Public ContactYong Cheng
Central Theater Command General Hospital
Outcome results
None listed