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.
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