MSC EVs in Dystrophic Epidermolysis Bullosa

Recruiting Phase 1 Phase 2 Interventional Study
Dystrophic Epidermolysis Bullosa
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
6 Months and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
8 (estimated)
Sponsor
Aegle Therapeutics · Industry
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About This Trial
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 effe…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Subjects must be 6 months or older at screening. 2. Subjects who have a confirmed diagnosis of DEB based on electron microscopy, immunomapping, or genetic testing. Subjects with severe DEB (e.g., RDEB patients with absent Col VII/no anchoring fibrils) and milder forms of DEB …
Contacts

Mei Chen, Ph.D.

323-865-0621

chenm@usc.edu

CONTACT