Self-Assembled Skin Substitute for the Treatment of Epidermolysis Bullosa

NCT ID: NCT04171661

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2026-12-18

Brief Summary

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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.

Detailed Description

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Conditions

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Epidermolysis Bullosa Dystrophica

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

n-of-one
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SASS

SASS applied on chronic skin wounds as skin graft

Group Type EXPERIMENTAL

SASS

Intervention Type BIOLOGICAL

SASS applied on chronic skin wounds as skin graft

Interventions

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SASS

SASS applied on chronic skin wounds as skin graft

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

This clinical trial was custom designed for one patient
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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LOEX 019

Identifier Type: -

Identifier Source: org_study_id

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