Actively Recruiting
Mesenchymal Stem Cell Extracellular Vesicles for Treating Wounds in Recessive Dystrophic Epidermolysis Bullosa
Led by Aegle Therapeutics · Updated on 2025-06-25
8
Participants Needed
3
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AGLE-102, an investigational product made of extracellular vesicles derived from donor mesenchymal stem cells, for treating wounds in people with Dystrophic Epidermolysis Bullosa (DEB), a condition causing persistent skin wounds. This phase 1/2A randomized, multi-center study aims to assess the safety and initial effectiveness of AGLE-102 on wounds that have lasted at least four weeks in DEB patients. Participants with two similar wounds each between 10 and 50 cm2 are enrolled, with one wound randomly assigned to receive up to six topical administrations of AGLE-102 approximately every two weeks over 10 weeks alongside standard wound care. The other wound receives standard care alone. After treatment, wounds are monitored every four weeks for 12 weeks to assess healing and scar quality, with no influence on treatment schedules based on control wound status. Participants undergo regular evaluations including wound healing assessments, safety monitoring for adverse events over 22 weeks, and measures of pain relief and quality of life. Wound closure is confirmed by complete re-epithelialization without re-injury. The study involves informed consent and follow-up visits to verify wound status and scar improvements, with an enrollment target of eight subjects.
CONDITIONS
Brief Title
MSC EVs in Dystrophic Epidermolysis Bullosa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 6 months old or older at screening.
- Confirmed diagnosis of Dystrophic Epidermolysis Bullosa by electron microscopy, immunomapping, or genetic testing.
- Two wounds present for at least four weeks, each between 10 and 50 cm2, and at least 4 inches apart with similar size and healing characteristics.
- No treatment other than standard care on study wounds in the past 3 months.
- Females of childbearing potential must have negative pregnancy test 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 give informed consent; minors must provide assent with guardian consent.
- Willingness to follow study protocol requirements.
You will not qualify if you...
- Use of local or systemic treatments other than standard care on study wounds during the study.
- Study wounds located within 6 inches of other wounds treated with local therapy.
- Evidence of systemic infection.
- History of bone marrow transplantation.
- Diagnosed clinically significant autoimmune disease.
- Wounds crossing fingers, toes, pubic, or perineum regions.
- Active infection at wound site.
- Current malignancy, life expectancy less than 2 years, or severe cardiopulmonary disease limiting clinic visits.
- History of blood clotting disorders.
- Chronic use of systemic steroids or immunosuppressants.
- Allergy to human albumin, streptomycin, or penicillin.
- Likely recipient of tissue or organ transplant.
- Current or recent (within 12 months) alcohol or substance abuse.
- History of poor compliance or unreliability.
- Pregnant, nursing, or planning pregnancy during study participation.
- Participation in another investigational drug, biologic, or device trial that could affect study data.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 10 weeks
Participants receive up to six topical administrations of extracellular vesicles derived from allogeneic mesenchymal stem cells to wounds, approximately two weeks apart, alongside standard wound care.
Up to 6 visits approximately two weeks apart
Duration - 12 weeks
Participants return for wound closure verification and scar quality assessment, with visits every 4 weeks after treatment for monitoring wound healing and safety.
Visits every 4 weeks for up to 12 weeks
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.
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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