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Tissue Engineering

Skin Substitute for Epidermolysis Bullosa (SASS Trial)

Phase < 1
Waitlist Available
Research Sponsored by CHU de Quebec-Universite Laval
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new type of skin substitute on a patient with a chronic skin condition. The hope is that this new skin will help the patient's wounds heal.

Who is the study for?
This trial is specifically designed for a single patient with dystrophic epidermolysis bullosa, who has chronic open wounds not healing with dressings or medications. There are no general eligibility criteria as it's tailored to this one individual.
What is being tested?
The trial is testing Self-Assembled Skin Substitutes (SASS) on a patient with severe skin condition, aiming to cover and potentially heal chronic open wounds that haven't responded to other treatments.
What are the potential side effects?
Since the study is custom-designed for one person, side effects will be monitored closely but may include typical reactions related to skin grafting such as infection, rejection of the substitute, or inflammation at the wound site.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent reduction in wound surface area
Secondary study objectives
Changes in itch scores where 0 is none and 10 the worst itch
Changes in pain scores
Graft failure
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SASSExperimental Treatment1 Intervention
SASS applied on chronic skin wounds as skin graft

Find a Location

Who is running the clinical trial?

CHU de Quebec-Universite LavalLead Sponsor
171 Previous Clinical Trials
109,604 Total Patients Enrolled
The Hospital for Sick ChildrenOTHER
710 Previous Clinical Trials
6,958,184 Total Patients Enrolled
2 Trials studying Epidermolysis Bullosa
11 Patients Enrolled for Epidermolysis Bullosa

Media Library

SASS (Tissue Engineering) Clinical Trial Eligibility Overview. Trial Name: NCT04171661 — Phase < 1
Epidermolysis Bullosa Research Study Groups: SASS
Epidermolysis Bullosa Clinical Trial 2023: SASS Highlights & Side Effects. Trial Name: NCT04171661 — Phase < 1
SASS (Tissue Engineering) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04171661 — Phase < 1
~0 spots leftby Nov 2025
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