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

BEAUTECH

Status: Not yet enrolling

Conditions: Impaired Glucose Tolerance

Treatments: Biological: Intravenous infusion of extracellular vesicle preparation derived from Wharton's jelly mesenchymal stem cells.

Study type: Interventional

Funder types: Industry

Identifiers

NCT06495437

91469002MA5RCDY83W

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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;

6. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

single arm study

Experimental group

Description:

Subjects who met the inclusion criteria were intravenously infused with 100ml extracellular vesicles derived from umbilical cord mesenchymal stem cells, at a rate of 1-1.5 hours

Treatment:

Biological: Intravenous infusion of extracellular vesicle preparation derived from Wharton's jelly mesenchymal stem cells.