NCT04171661

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for early_phase_1

Timeline
5mo left

Started Dec 2019

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Dec 2019Dec 2026

First Submitted

Initial submission to the registry

November 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

December 10, 2019

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2019

Completed
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2026

Expected
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

14 days

First QC Date

November 19, 2019

Last Update Submit

March 17, 2026

Conditions

Epidermolysis Bullosa Dystrophica

Keywords

Dystrophic Epidermolysis BullosaRecessive Dystrophic Epidermolysis BullosaTissue EngineeringSkin Substitute

Outcome Measures

Primary Outcomes (1)

  • Percent reduction in wound surface area

    Clinical assessment

    2 weeks

Secondary Outcomes (6)

  • Graft failure

    2 weeks

  • Number of subsequent re-transplantation

    3 years

  • Time (in weeks) to 50% reduction in the surface area of the wounds;

    3 years

  • Time (in weeks) to complete healing

    3 years

  • Changes in pain scores

    3 years

  • +1 more secondary outcomes

Study Arms (1)

SASS

EXPERIMENTAL

SASS applied on chronic skin wounds as skin graft

Biological: SASS

Interventions

SASSBIOLOGICAL

SASS applied on chronic skin wounds as skin graft

SASS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
This clinical trial was custom designed for one patient

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Epidermolysis Bullosa Dystrophica

Condition Hierarchy (Ancestors)

Epidermolysis BullosaSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesSkin Diseases, Vesiculobullous

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: n-of-one
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2019

First Posted

November 21, 2019

Study Start

December 10, 2019

Primary Completion

December 24, 2019

Study Completion (Estimated)

December 18, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)