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

NCT06813027 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-04-30

No results posted yet for this study

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.

Conditions

  • Vitiligo

Interventions

BIOLOGICAL

EV

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

Sponsors & Collaborators

  • Abdalla Awidi Abbadi, MD

    collaborator UNKNOWN

  • University of Jordan

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2026-01-30
Completion
2027-01-30

Countries

  • Jordan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06813027 on ClinicalTrials.gov