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MSC EVs in Dystrophic Epidermolysis Bullosa

NCT04173650 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-06-25

No results posted yet for this study

Summary

INVESTIGATIONAL PRODUCT: AGLE-102 is an allogeneic extracellular vesicle (EV) product derived from normal donor mesenchymal stem cells (MSCs).

INDICATION AND RATIONALE: The aim of the study is to assess the safety and efficacy of AGLE-102 in the treatment of lesions in subjects with Epidermolysis Bullosa (EB).

STUDY DESIGN: This is a phase 1/2A, randomized, multi-center, study to assess the effectiveness and safety of AGLE-102 on lesions in subjects with EB.

Conditions

  • Dystrophic Epidermolysis Bullosa

Interventions

DRUG

AGLE-102

Extracellular vesicles from bone marrow derived mesenchymal stem cells - up to six topical administrations

Sponsors & Collaborators

  • Aegle Therapeutics

    lead INDUSTRY

Principal Investigators

  • David T Woodley, MD · University of Southern California Dept of Dermatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-13
Primary Completion
2025-09-30
Completion
2026-03-31
FDA Drug
Yes

Countries

  • United States

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 NCT04173650 on ClinicalTrials.gov