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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
SASS Trial 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.Check my eligibility
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.See study design
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.
SASS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent reduction in wound surface area
Secondary outcome measures
Changes in itch scores where 0 is none and 10 the worst itch
Changes in pain scores
Graft failure
+3 moreSASS Trial Design
1Treatment groups
Experimental Treatment
Group I: SASSExperimental Treatment1 Intervention
SASS applied on chronic skin wounds as skin graft
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Who is running the clinical trial?
CHU de Quebec-Universite LavalLead Sponsor
167 Previous Clinical Trials
107,156 Total Patients Enrolled
The Hospital for Sick ChildrenOTHER
686 Previous Clinical Trials
6,944,792 Total Patients Enrolled
2 Trials studying Epidermolysis Bullosa
11 Patients Enrolled for Epidermolysis Bullosa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- This trial is designed for one specific patient, so there are no general requirements for participation.
Research Study Groups:
This trial has the following groups:- Group 1: SASS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrollees being accepted at this stage of the clinical trial?
"In accordance with information available on clinicaltrials.gov, this particular study is not currently accepting volunteers. It was first listed on December 10th 2019 and the most recent update came from January 25th 2021. However, there are 28 other trials actively searching for candidates at present time."
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