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

NCT06813027 | Active Not Recruiting Phase 1

• 1 other identifier: EV-Vitiliogo-CTC
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Safety

  Safety was the primary endpoint. Adverse events were monitored. Immediately after injection, each subject was kept for one hour of observation in the Cell Therapy Center (CTC). Subjects were followed for 24 hours and then weekly for the first month. Subsequently, they were followed monthly until the end of the study using a special checklist for adverse events as described . Measuring visible adverse events such as redness, localized itching, and skin edema score

  6 months

Secondary Outcomes (1)

• Efficacy of response

  6 months

Study Arms (2)

Extracellular vesicles (EV)

EXPERIMENTAL

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

Biological: EV

Control

NO INTERVENTION

No intervention

Interventions

EV BIOLOGICAL

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

Extracellular vesicles (EV)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Additionally, subjects must have normal kidney function, liver function, blood pressure, no heart or lung diseases, and no history of allergies. The following subjects were excluded from the study: those under 18 years of age, pregnant women, patients with new lesions, actively spreading vitiligo, bleeding disorders, active malignancy, heart failure, uncontrolled hypertension, active hepatitis or transmissible disease, history of Koebnerization, history of hypertrophic scars or keloidal tendency, history of allergy, and patients on anticoagulants.

Sponsors & Collaborators

• University of Jordan: lead
• Abdalla Awidi Abbadi, MD: collaborator

Study Sites (1)

Cell Therapy Center

Amman, 00962, Jordan

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 6, 2025
• Study Start: January 1, 2023
• Primary Completion: January 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)