NCT06810869

Induced Pluripotent Stem Cell Derived Exosomes Nasal Drops for the Treatment of Stable Vitiligo

Exploratory Clinical Study on Induced Pluripotent Stem Cell Derived Exosomes (iPSC-Exos) for the Treatment of Stable Vitiligo

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Second Affiliated Hospital of Wannan Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the efficacy of induced pluripotent stem cell-derived exosomes (iPSC-Exos) for the treatment of stable vitiligo

Detailed description

This study aims to evaluate the efficacy and safety of iPSC-Exos in the treatment of localized stable vitiligo. iPSC-Exos have been found to possess the ability to promote cell survival, proliferation, and repair, potentially improving skin pigmentation in vitiligo patients by modulating the survival and function of melanocytes. This study will consist of 2 parts, with part 1 being a dose-escalation study and part 2 being an expanded safety study based on part 1 findings. A traditional 3+3 dose escalation design will be implemented in part 1. Cohort 1: receive 1×10\^8 particles per time; cohort 2: 3×10\^8 particles per time and cohort 3: 9×10\^8 particles per time. In part 2, 20 subjects will be randomized in a 1:1 ratio \[exosome (n=10) or exosome placebo (n=10)\]. The dose level will be determined by Data Safety Monitoring Board based on part 1.

Conditions

• Stable Vitiligo

Interventions

Type	Name	Description
DRUG	human induced pluripotent stem cell derived exosomes （GD-iExo-003）	human induced pluripotent stem cell derived exosomes （GD-iExo-003）
DRUG	a placebo of exosomes derived from human induced pluripotent stem cell for injection	a placebo of exosomes derived from human induced pluripotent stem cell for injection

Timeline

• Start date: 2025-02-05
• Primary completion: 2026-11-17
• Completion: 2026-11-17
• First posted: 2025-02-06
• Last updated: 2025-02-06

Locations

1 site across 1 country: China