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

First listed
Nov 22, 2019
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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