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ACTIVE NOT RECRUITING
NCT06813027
PHASE1

Use of Allogeneic Extracellular Secretomes (EV)Derived From Umbilical Cord Mesenchymal Stromal Cells: a Phase I Open-label Safety Trial.

Sponsor: University of Jordan

View on ClinicalTrials.gov

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

BIOLOGICAL

EV

Extracellular secretomes ( extracellular vesicles "EV") derived from mesenchymal stroma cells (MSCs)

Locations (1)

Cell Therapy Center

Amman, Jordan