The objective of this exploratory study was to evaluate the initial safety of human mesenchymal stem cell-derived extracellular vesicle infusion in an age-related phenotype with impaired glucose tolerance
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The trial protocol includes a 3-week screening period and a 12-week study period after enrollment. The specific trial protocol is detailed in the figure above. Cell-derived extracellular vesicle formulation will be administered at week 0, with central visits conducted during the administration period. Central visits will also be conducted at weeks 1, 4, and 12 post-administration, with a phone visit at week 8. The entire study will last for 12 weeks. Following the final follow-up visit, further observation of the intervention's effects and safety will continue for an additional 3 months. During this 3-month period, there will be no artificial intervention or restriction on the medication and biological methods for the participants in each group.
safety evaluation
Incidence of adverse events from baseline to the end of 12 weeks. The frequency and frequency of adverse events (including injection site reactions) were analyzed. The number of cases and cases of adverse events, adverse reactions, AES leading to fall off, SAE, aes of different severity, AES leading to death were calculated respectively, and a detailed list was provided. The incidence rate was calculated using the number of people in each safety dataset as the denominator, and if necessary, Chi-square test or Fisher exact probability method was used for inter-group comparison.
Time frame: 0-12 weeks
Effectiveness evaluation
glycated hemoglobin -1
Time frame: 0-12 weeks
Effectiveness evaluation
endocrine hormones (gonadal hexa, DHEA, IGF-1)
Time frame: 0-12 weeks
Effectiveness evaluation
blood glucose level
Time frame: 0-12 weeks
Effectiveness evaluation
insulin secretion index
Time frame: 0-12 weeks
Effectiveness evaluation
HOMA-β indexes
Time frame: 0-12 weeks
Effectiveness evaluation
HOMA-IR indexes
Time frame: 0-12 weeks
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