NCT04173650 · Aegle Therapeutics
MSC EVs in Dystrophic Epidermolysis Bullosa
What this study is about
experimental 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 effectiveness of AGLE-102 in the treatment of lesions in subjects with Epidermolysis Bullosa (EB).
View original scientific description
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.
Interventions
DRUG
AGLE-102
Extracellular vesicles from bone marrow derived mesenchymal stem cells - up to six topical administrations
Primary outcome measures
Treatment-emergent Adverse Events
Time frame: 22 weeks
Incidence of adverse events after single and repeat administrations of EVs
Wound healing improvement
Time frame: 10 weeks
Change in wound surface area relative to baseline compared with standard of care control
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 (e.g., RDEB patients with reduced Col VII and/or anchoring fibril levels) are eligible. 3. Presence for at least four weeks of two 10 - 50 cm2 wounds (unroofed EB erosions) at least 4 inches apart that can be considered similar enough in size, wound location and expected healing characteristics to be a matched pair. Neither index wound may have been treated with any local (topical, subcutaneous, etc) or systemic therapeutic other than standard of care treatments described in this protocol (i.e. local or systemic antimicrobials to control infection, topical anesthetic and oral analgesics if required) in the past 3 months prior to screening. 4. Females of childbearing potential must have a neg
Where
- Phoenix, Arizona
- Los Angeles, California
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
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Data: ClinicalTrials.gov · synced Jun 25, 2025 · Source of record for eligibility and locations