Evaluate the Safety and Efficacy of Exosomes Derived from Allogenic Adipose Mesenchymal Stem Cells(MSCs-Exos)in Subjects with Alzheimer's disease.
To date, the main pathological characteristics of AD patients are the accumulation of β-amyloid (Aβ) into senile plaques, the abnormal aggregation of intracellular Tau protein to form neuron fiber tangles (NFT) and neuron death. There are still no effective treatments to prevent, halt, or reverse Alzheimer's disease. Exosomes are naturally occurring nanosized vesicles and comprised of natural lipid bilayers with the abundance of adhesive proteins that readily interact with cellular membranes. These vesicles have a content that includes cytokines and growth factors, signaling lipids, mRNAs, and regulatory miRNAs. Exosomes are involved in cell-to-cell communication, cell signaling, and altering cell or tissue metabolism at short or long distances in the body, and can influence tissue responses to injury, infection, and disease. The purpose of this single center, open label, phase I/Ⅱ clinical trial, therefore, is to explore the safety and efficacy of the exosomes derived from allogenic adipose mesenchymal stem cells (MSCs-Exos) in the treatment of mild to moderate dementia due to Alzheimer's Disease.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Dosage:5μg MSCs-Exos,Total volume: 1ml Frequency:Twice a week Duration:12 weeks
Dosage:10μg MSCs-Exos,Total volume: 1ml Frequency:Twice a week Duration:12 weeks
Dosage:20μg MSCs-Exos,Total volume: 1ml Frequency:Twice a week Duration:12 weeks
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGNumber of participants with treatment-related abnormal laboratory values of Liver or kidney function
Time frame: 12 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 12 weeks
Cognitive function
ADAS-cog (Alzheimer 's disease assessment scale-cognitive section) consists of 12 items. Maximum value is 70 and higher score means a worse congnitive condition.
Time frame: baseline
Cognitive function
ADAS-cog (Alzheimer 's disease assessment scale-cognitive section) consists of 12 items. Maximum value is 70 and higher score means a worse congnitive condition.
Time frame: 12 weeks
Cognitive function
ADAS-cog (Alzheimer 's disease assessment scale-cognitive section) consists of 12 items. Maximum value is 70 and higher score means a worse congnitive condition.
Time frame: 24 weeks
Cognitive function
ADAS-cog (Alzheimer 's disease assessment scale-cognitive section) consists of 12 items. Maximum value is 70 and higher score means a worse congnitive condition.
Time frame: 36 weeks
Cognitive function
ADAS-cog (Alzheimer 's disease assessment scale-cognitive section) consists of 12 items. Maximum value is 70 and higher score means a worse congnitive condition.
Time frame: 48 weeks
Quality of life evaluation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Scores of ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) range from 0 to 54 and higher score means a better life quality.
Time frame: baseline
Quality of life evaluation
Scores of ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) range from 0 to 54 and higher score means a better life quality.
Time frame: 12 weeks
Quality of life evaluation
Scores of ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) range from 0 to 54 and higher score means a better life quality.
Time frame: 24 weeks
Quality of life evaluation
Scores of ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) range from 0 to 54 and higher score means a better life quality.
Time frame: 36 weeks
Quality of life evaluation
Scores of ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) range from 0 to 54 and higher score means a better life quality.
Time frame: 48 weeks
MRI Neuroimaging
Evaluation of MRI(Magnetic Resonance Imaging)
Time frame: baseline
MRI Neuroimaging
Evaluation of MRI(Magnetic Resonance Imaging)
Time frame: 48 weeks
PET-CT Neuroimaging
Evaluation of and PET-CT(Positron Emission Computed Tomography- Computed Tomography)
Time frame: baseline
PET-CT Neuroimaging
Evaluation of and PET-CT(Positron Emission Computed Tomography- Computed Tomography)
Time frame: 48 weeks