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Use of Allogeneic Extracellular Secretomes (EV)Derived From Umbilical Cord Mesenchymal Stromal Cells: a Phase I Open-label Safety Trial.
Sponsor: University of Jordan
Summary
Aim of the study: The primary endpoint of this work is to explore the safety of allogeneic extracellular secretomes "extracellular vesicles" (EV) derived from umbilical cord mesenchymal cells (HUCMSCs) when injected perilesional repeatedly in stable non-facial vitiligo. Methods: Adults with stable non-facial vitiligo for more than three months not exceeding 300 mm 2 were included in the study. A total of 13 patients of either gender, were given perilesional EV weekly for 3 weeks. Adverse events were regularly monitored for six months. The re-pigmentation was assessed at 3 and 6 months The non-injected areas are used as control for comparison of repigmentation. The injected skin area and the control areas were photographed at baseline, at the end of treatment, and at three, and six months.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
13
Start Date
2023-01-01
Completion Date
2027-01-30
Last Updated
2025-04-30
Healthy Volunteers
No
Conditions
Interventions
EV
Extracellular secretomes ( extracellular vesicles "EV") derived from mesenchymal stroma cells (MSCs)
Locations (1)
Cell Therapy Center
Amman, Jordan