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NOT YET RECRUITING
NCT07707986
PHASE1

Safety of Topical Exosome-Containing Liquid in Healthy Volunteers for Future Surgical Wound Use

Sponsor: West Kazakhstan Marat Ospanov Medical University

View on ClinicalTrials.gov

Summary

This Phase 1 split-site pilot study will evaluate the safety and dermal tolerability of a topical exosome-containing liquid in 10 healthy adult volunteers. The investigational liquid will be applied to a small defined area of intact skin. A vehicle liquid without exosomes may be applied to a matched contralateral skin site as a control. The study will assess local skin reactions, systemic adverse events, vital signs, clinical laboratory parameters, and feasibility of topical administration. No melanoma lesion, surgical wound, burn wound, or artificial skin wound will be induced in participants in this Phase 1 safety study.

Official title: A Phase 1 Split-Site Pilot Study to Evaluate the Safety and Dermal Tolerability of Topical Exosome-Containing Liquid in Healthy Adult Volunteers Before Future Testing in Post-Melanoma-Excision Surgical Wounds

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-09

Completion Date

2027-01

Last Updated

2026-07-16

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Exosome-Containing Liquid

The investigational product is a sterile topical liquid containing exosome-enriched extracellular vesicles derived from human umbilical cord-derived mesenchymal stromal cells. The liquid will be applied topically to a small defined area of intact skin at a dose of 0.1 mL/cm², containing 1 × 10\^10 extracellular vesicle particles/mL, equivalent to 1 × 10\^9 extracellular vesicle particles/cm², according to the approved protocol-defined schedule. The product is investigational and is being evaluated for safety and dermal tolerability before future testing in patients with postoperative wounds after melanoma excision.

OTHER

Vehicle Liquid

Vehicle liquid without exosomes will be applied topically to a matched contralateral intact skin site according to the same protocol-defined schedule as the exosome-containing liquid. The vehicle liquid is used as a within-participant control for local dermal tolerability assessment.

Locations (1)

ATMP center of West Kazakhstan Marat Ospanov Medical University

Aktobe, Aktobe, Kazakhstan