Clinical trial

SASS 3: Self-Assembled Skin Substitute (SASS) for the Treatment of Epidermolysis Bullosa

Name

LOEX 019

Description

Single patient study. Patient diagnosed with dystrophic epidermolysis bullosa presenting chronic open wounds that are not responding to dressings, topical preparations (antimicrobials, antibiotics) and systemic agents (anti-inflammatory antibacterials). The Self-Assembled Skin Substitutes will be used to cover wounds.

Trial arms

Trial start

2019-12-10

Estimated PCD

2019-12-24

Trial end

2024-12-10

Status

Active (not recruiting)

Phase

Early phase I

Treatment

SASS

SASS applied on chronic skin wounds as skin graft

Arms:

SASS

Size

Primary endpoint

Percent reduction in wound surface area

2 weeks

Eligibility criteria

This clinical trial was custom designed for one patient

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'n-of-one', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1, 'type': 'ACTUAL'}}

Updated at

2023-02-17

1 organization

1 product

1 indication

Organization

CHU de Quebec-Universite Laval

Product

SASS

Indication

Epidermolysis Bullosa Dystrophica