20
Participants
Start Date
August 1, 2024
Primary Completion Date
August 1, 2026
Study Completion Date
December 31, 2026
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.
BEAUTECH
INDUSTRY