Patients with Alzheimer'
Conditions
Interventions
All AD 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
Using a single-arm open-label design, mesenchymal stem cells are used to intervene in patients with Alzheimer'
Sponsors
Zibo 148 Hospital
Shandong Sport University
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for Alzheimer's disease (2018 NIAAA diagnostic criteria), 2. Excludes other neurodegenerative diseases, 3. MMSE score between 11 and 26 points, 4. Has good vision and hearing functions, 5. Can understand instructions and cooperate to complete scale assessments, 6. Has motor ability, able to walk at least 400 meters with assistive devices, 7. No severe viral or bacterial infections, 8. Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) greater than the lower limit of normal (50%), 9. Condition stable, complications well-controlled, no contraindications for anesthesia, no contraindications for directional surgery, and no other situations that interfere with clinical evaluation, 10. Levels of calcium, potassium, and magnesium in serum are within standard ranges, 11. ECOG performance status score between 0 and 2, 12. Chest CT shows no evidence of acute inflammatory infection, 13. Hematological parameters were within the relevant criteria one week before treatment.(no blood components or cell growth factors allowed within 14 days prior to screening), 14. No bleeding disorders or coagulopathy, 15. Non-surgical sterilization or women of childbearing age must use a medically accepted contraceptive method (such as an intrauterine device [IUD], contraceptive pills, or condoms) during the study treatment period and for three months after the end of the study treatment, women of childbearing age who are non-surgically sterilized must have a negative serum or urine HCG test within 7 days prior to study enrollment; must not be breastfeeding; women who have undergone sterilization or have been postmenopausal for at least two years can be deemed infertile, 16. Subjects voluntarily participate in this study and sign an informed consent form, provide biological samples, demonstrate good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Inability to understand the purpose of the study and or protocol procedures 2. Having contraindications for magnetic resonance imaging (MRI) 3. Other neurological diseases that cause cognitive impairment such as temporal lobe dementia epilepsy and vascular dementia 4. Physical disability that prevents regular exercise 5. Subjects with any active autoimmune disease or a history of autoimmune disease including but not limited to interstitial lung disease uveitis enteritis hepatitis hypophysitis vasculitis nephritis hyperthyroidism and hypothyroidism Subjects with vitiligo or childhood asthma that has been in complete remission without any intervention in adulthood may be enrolled Subjects with asthma requiring medical intervention with bronchodilators shall be excluded 6. Known or suspected allergy or severe adverse reaction to the components of the investigational product or individuals with an allergic constitution 7. Coagulation dysfunction 8. Subjects with clinically symptomatic central nervous system metastases such as cerebral edema requiring hormone intervention or progressive brain metastases 9. Patients who have received cytotoxic drug therapy within the last three months prior to enrollment 10. Presence of any of the following cardiovascular or cerebrovascular conditions clinically significant cardiac disease occurring within six months prior to enrollment including congestive heart failure of severity greater than New York Heart Association Class II unstable angina that is angina symptoms at rest new onset angina within three months prior to enrollment or myocardial infarction ventricular arrhythmia requiring treatment with antiarrhythmic drugs QTc interval longer than four hundred and seventy milliseconds poorly controlled hypertension with systolic blood pressure higher than one hundred and fifty millimeters of mercury or diastolic blood pressure higher than one hundred millimeters of mercury thrombotic or embolic venous or arterial events occurring within six months prior to enrollment such as cerebrovascular accident including transient ischemic attack stroke arterial thrombosis deep vein thrombosis and pulmonary embolism 11. Long standing unhealed wounds or fractures of the chest or other sites 12. Patients with any prior history of cell therapy 13. Subjects with congenital or acquired immunodeficiency such as HIV infection or active hepatitis hepatitis B with positive HBsAg hepatitis C with positive anti HCV antibody and HCV RNA level above the limit of detection 14. Subjects with a known history of psychoactive substance abuse alcoholism or drug addiction 15. Pregnant or lactating women 16. Participation in the treatment of another clinical study within thirty days prior to the start of treatment and the start of the study 17. In the judgment of the investigator subjects with other factors that may lead to premature termination of the study such as other severe diseases including psychiatric disorders requiring combined treatment severe abnormal laboratory findings or family and social factors that may affect subject safety or the collection of study data and samples 18. Severe cognitive impairment depression or behavioral disorder defined as a Mini Mental State Examination (MMSE) score less than eleven a Hamilton Depression Rating Scale (HAMD) score higher than thirty five or patients unable to understand and sign the informed consent form 19. Subjects with a concurrent tumor or a history of tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mini-Mental State Examination Before treatment, after intervention, 2 months after intervention Scale,Montreal Cognitive Assessment Before treatment, after intervention, 2 months after intervention Scale,ADAS-Cog Before treatment, after intervention, 2 months after intervention Scale,ADCS-ADL Before treatment, after intervention, 2 months after intervention Scale,CDR-SB Before treatment, after intervention, 2 months after intervention Scale,Digit Span Test Before treatment, after intervention, 2 months after intervention Scale,Magnetic Resonance Imaging (MRI) Before treatment, 2 months after intervention 3 Tesla Magnetic Resonance Imaging (3T-MRI),Cerebrospinal Fluid Examination Before treatment,2 months after intervention Analysis of cerebrospinal fluid metabolites and biomarkers,Blood Biomarkers Before treatment, after intervention, 2 months after intervention Blood Metabolite and Biomarker Analysis,Safety Assessment: Adverse Events and Serious Adverse Events 48 hours after each intervention Adverse Event Record Form | — |
Secondary
| Measure | Time frame |
|---|---|
| Berg Balance Scale (BBS) Before treatment, after intervention, 2 months after intervention Scale,Pittsburgh Sleep Quality Index (PSQI) Before treatment, after intervention, 2 months after intervention Scale,Hamilton Depression Rating Scale (HAMD/HDRS) Before treatment, after intervention, 2 months after intervention Scale,Hamilton Anxiety Rating Scale (HAMA) Before treatment, after intervention, 2 months after intervention Scale,Borg Rating of Perceived Exertion (RPE) Scale Before treatment, after intervention, 2 months after intervention Scale | — |
Countries
China
Contacts
Public ContactYunliang Wang
Zibo 148 Hospital
Outcome results
None listed