Actively Recruiting
MSC EVs in Dystrophic Epidermolysis Bullosa
Led by Aegle Therapeutics · Updated on 2025-06-25
8
Participants Needed
3
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
MSC EVs in Dystrophic Epidermolysis Bullosa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must be 6 months or older at screening.
- Confirmed diagnosis of Dystrophic Epidermolysis Bullosa (DEB) by electron microscopy, immunomapping, or genetic testing.
- Presence of two wounds between 10 and 50 cm2 in size, each persisting for at least four weeks and at least 4 inches apart, similar in size, location, and healing characteristics.
- Neither wound treated with local or systemic therapies other than standard care in the past 3 months.
- Females of childbearing potential must have a negative pregnancy test at screening and agree to use acceptable birth control during the study.
- Post-pubertal males must agree to use acceptable contraception during the study.
- Participants 18 years or older must be able to provide informed consent; those under 18 must provide assent if appropriate and have guardian consent.
- Willingness to comply with study requirements.
You will not qualify if you...
- Use of local or systemic treatments other than standard care on study wounds at screening or during the study.
- Study wounds located within 6 inches of wounds treated with other local therapies.
- Evidence of systemic infection.
- History of bone marrow transplant.
- Diagnosed clinically significant autoimmune disease.
- Wounds extending across fingers, toes, pubic or perineum regions.
- Active infection at wound sites.
- Current malignancy, life expectancy less than 2 years, or severe cardiopulmonary disease limiting mobility.
- History of coagulopathy.
- Chronic use of systemic steroids or immunosuppressive agents.
- Allergy to human albumin, streptomycin, or penicillin.
- Likely to receive tissue or organ transplantation.
- History of alcohol or substance abuse requiring treatment within past 12 months.
- History of poor compliance or unreliability.
- Females who are pregnant, nursing, or planning pregnancy during the study.
- Participation in other investigational drug, biologic, or device studies that could affect results.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
USC /Norris Comprehensive Cancer Center University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
M
Mei Chen, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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