Clinical trial NCT06495437: Preliminary Safety and Efficacy Study of Extracellular Vesicle Infusion in the Intervention of Age-related Phenotypes With Impaired Glucose Tolerance.
Official title: Preliminary Safety and Efficacy Study of Extracellular Vesicle Infusion in the Intervention of Age-related Phenotypes With Impaired Glucose Tolerance.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Impaired Glucose Tolerance
Keywords: Extracellular Vesicle
Aging
Human Mesenchymal Stem Cells
impaired glucose tolerance
Lead sponsor: BEAUTECH
Sponsor class: INDUSTRY
First posted: 2024-07-10
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

1. The subjects are between 35 and 65 years old (inclusive), regardless of gender;
2. The subject's body mass index (BMI) is between 20kg/m2 and 30 kg/m2;
3. The subjects were assessed by the clinical expert group as having abnormal glucose tolerance (PPG 7.8-11.0mmol/L 2h postprandial);
4. Subjects voluntarily participate in this clinical study and sign a written informed consent.

Exclusion Criteria:

1. The subject has a severe allergy or is allergic to any component used in cell culture;
2. The subject has used or is using drugs that affect glucose metabolism (such as glucocorticoids, tricyclic antidepressants, etc.) within 1 month;
3. The subjects have chronic diseases such as diabetes and hypertension (very high-risk group) which have not been effectively controlled after treatment;
4. 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;
5. The subjects had abnormal liver function (ALT and/or AST≥ 2.5 times the upper limit of normal), significant abnormal renal function, male serum creatinine ≥1.5mg/dl, female serum creatinine ≥1.4mg/dl; 6, the subject's HIV antibody, hepatitis B surface antigen, hepatitis C antibody, syphilis test positive, hepatitis B virus DNA quantitative \> the upper limit of normal test unit;

7. Subjects with other serious systemic diseases affecting the study, including malignant tumors, nervous central system, blood system, digestive system, endocrine system, respiratory system, infectious diseases, etc.; (8) Drug or alcohol abuse (subjects who consumed \>2 alcoholic beverages per day or \>14 alcoholic beverages per week (one alcoholic beverage is defined as 150ml of wine, 350ml of beer, or 50ml of 80% (40 proof) spirits); Or drug abusers; 9. Pregnant and lactating women; Have a pregnancy plan in the next 2 years (including the spouse's pregnancy plan); Refusal to use effective contraception; 10. Exclude intracranial lesions and early lung tumors; 11. Used stem cell (exosome) therapy or participated in stem cell (exosome) clinical researchers 3 months before screening; Clinical investigators who have participated in drugs within 3 months before screening; 12. High risk groups with Padua score ≥4 or Caprini score ≥5; 13. The subject has a history of major surgery within the past six months or is expected to have surgery within six months; 14. There are other conditions that the researcher considers inappropriate to participate in this clinical study.

Primary outcomes:
measure: safety evaluation
timeFrame: 0-12 weeks
Secondary outcomes:
measure: Effectiveness evaluation
timeFrame: 0-12 weeks
measure: Effectiveness evaluation
timeFrame: 0-12 weeks
measure: Effectiveness evaluation
timeFrame: 0-12 weeks
measure: Effectiveness evaluation
timeFrame: 0-12 weeks
measure: Effectiveness evaluation
timeFrame: 0-12 weeks
measure: Effectiveness evaluation
timeFrame: 0-12 weeks
Other outcomes:
Locations:
Study officials:
References: