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

Launched by BEAUTECH · Jul 8, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the safety and potential benefits of a treatment using special particles called extracellular vesicles, derived from human stem cells, for people who are experiencing issues with glucose tolerance due to aging. Glucose tolerance is how well your body manages sugar after eating, and impaired glucose tolerance can increase the risk of diabetes. The study aims to see if this treatment can help improve this condition safely.

To participate, individuals need to be between 35 and 65 years old and have a body mass index (BMI) between 20 and 30, which means they are within a healthy weight range. They also need to show signs of abnormal glucose tolerance. However, people with certain health conditions, such as severe allergies, uncontrolled chronic diseases, or those who have recently used specific medications that affect blood sugar levels, won't be eligible. The trial is not yet recruiting participants, but those who join will be closely monitored to ensure their safety during the study.

Gender

ALL

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.