MSC EVs in Dystrophic Epidermolysis Bullosa

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Aegle Therapeutics
Study ID
NCT04173650
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Dystrophic Epidermolysis Bullosa

Eligibility Criteria

Sex
ALL
Age
6 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • AGLE-102 — DRUG
    Extracellular vesicles from bone marrow derived mesenchymal stem cells - up to six topical administrations

Study Details

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.

Key Dates

Start date
Aug 13, 2024
Status verified
Jun 2025
Primary completion
Sep 30, 2025
Completion
Mar 31, 2026

Study Design

Enrollment
8 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AGLE 102
    Treatment arm

Primary Outcome Measure

Treatment-emergent Adverse Events [ Time Frame: 22 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Phoenix Children's HospitalPhoenixArizona85016
Kellie Badger, BS, RN
[email protected]
602-933-2053
Harper N Price, MD, FAAD, FAAP (PRINCIPAL_INVESTIGATOR)
USC /Norris Comprehensive Cancer Center University of Southern CaliforniaLos AngelesCalifornia90033
Mei Chen, PhD
[email protected]
323-865-0621
David Woodley, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Griffin S Hogrogian, MSEd
[email protected]
215-590-1930
Marissa Perman, MD (PRINCIPAL_INVESTIGATOR)

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Phoenix Children's Hospital· Phoenix, AZUSC /Norris Comprehensive Cancer Center University of Southern California· Los Angeles, CAChildren's Hospital of Philadelphia· Philadelphia, PA

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