About this trial
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
Eligibility criteria
Qualifiers
The subjects are between 35 and 65 years old (inclusive), regardless of gender;
The subject's body mass index (BMI) is between 20kg/m2 and 30 kg/m2;
The subjects were assessed by the clinical expert group as having abnormal glucose tolerance (PPG 7.8-11.0mmol/L 2h postprandial);
Subjects voluntarily participate in this clinical study and sign a written informed consent.
Disqualifiers
The subject has a severe allergy or is allergic to any component used in cell culture;
The subject has used or is using drugs that affect glucose metabolism (such as glucocorticoids, tricyclic antidepressants, etc.) within 1 month;
The subjects have chronic diseases such as diabetes and hypertension (very high-risk group) which have not been effectively controlled after treatment;
Subjects with severe cardiovascular and cerebrovascular diseases: patients with a history of decompensated cardiac insufficiency (NYHA grade Ⅲ or Ⅳ), myocardial infarction or cerebral infarction, or cerebral hemorrhage within 6 months before screening;
Trial design
Treatments tested in this trial
- Intravenous infusion of extracellular vesicle preparation derived from Wharton's jelly mesenchymal stem cells.