NCT06495437

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: BEAUTECH · Industry
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Impaired Glucose Tolerance

Interventions

Type	Name	Description
BIOLOGICAL	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 observation of the intervention's effects and safety will continue for an additional 3 months. During this 3-month period, there will be no artificial intervention or restriction on the medication and biological methods for the participants in each group.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-08-01
• Completion: 2026-12-31
• First posted: 2024-07-10
• Last updated: 2024-07-19