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

Обзор

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

Вмешательства

• Биопрепарат Intravenous infusion of extracellular vesicle preparation derived from Wharton's jelly mesenchymal stem cells.
  The trial protocol includes a 3-week screening period and a 12-week study period after enrollment. The specific trial protocol is detailed in the figure above. Cell-derived extracellular vesicle formulation will be administered at week 0, with central visits conducted during the administration period. Central visits will also be conducted at weeks 1, 4, and 12 post-administration, with a phone visit at week 8. The entire study will last for 12 weeks. Following the final follow-up visit, further

Первичные конечные точки

• safety evaluation [Срок оценки: 0-12 weeks]

Вторичные конечные точки (6)

• Effectiveness evaluation [Срок оценки: 0-12 weeks]
• Effectiveness evaluation [Срок оценки: 0-12 weeks]
• Effectiveness evaluation [Срок оценки: 0-12 weeks]
• Effectiveness evaluation [Срок оценки: 0-12 weeks]
• Effectiveness evaluation [Срок оценки: 0-12 weeks]
• Effectiveness evaluation [Срок оценки: 0-12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06495437 · 91469002MA5RCDY83W

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗