Self-Assembled Skin Substitute for the Treatment of Epide... | NCT04171661

Studies
Self-Assembled Skin Substitute for the Treatment of Epidermolysis Bullosa

NCT04171661

Sponsor

CHU de Quebec-Universite Laval

Status

Active, not recruiting

Last Update Posted

Mar 19, 2026Actual

Enrollment

1Actual

Phase

Early Phase 1

Conditions

Epidermolysis Bullosa Dystrophica

Interventions

SASS

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 10, 2019Actual

Primary Completion Date

Dec 24, 2019Actual

Completion Date

Dec 18, 2026Estimated

First Submitted Date

Nov 19, 2019

First Submission Date that Met QC Criteria

Nov 19, 2019

First Posted Date

Nov 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2026

Last Update Posted Date

Mar 19, 2026Actual

Name	Class
The Hospital for Sick Children	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SASS	Experimental	SASS applied on chronic skin wounds as skin graft	Biological: SASS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SASS	Biological	SASS applied on chronic skin wounds as skin graft	SASS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent reduction in wound surface area	Clinical assessment	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Graft failure	Clinical assessment	2 weeks
Number of subsequent re-transplantation	Number	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

This clinical trial was custom designed for one patient

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Hospital for Sick Children		Toronto	Ontario	M5G 1X8	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016108	Epidermolysis Bullosa Dystrophica

Ancestor Terms

ID	Term
D004820	Epidermolysis Bullosa
D012868	Skin Abnormalities
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided