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

NANot yet recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

August 1, 2024

Primary Completion Date

August 1, 2026

Study Completion Date

December 31, 2026

Conditions
Impaired Glucose Tolerance
Interventions
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.

All Listed Sponsors
lead

BEAUTECH

INDUSTRY

NCT06495437 - Preliminary Safety and Efficacy Study of Extracellular Vesicle Infusion in the Intervention of Age-related Phenotypes With Impaired Glucose Tolerance. | Biotech Hunter | Biotech Hunter