Preliminary Safety and Efficacy Study of Extracellular Vesicle Infusion in the Intervention of Age-related Phenotypes With Impaired Glucose Tolerance.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-65
SponsorBEAUTECH

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.

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators