NCT02579369

Brief Summary

This is a phase I/II open-label study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Dystrophic Epidermolysis Bullosa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 16, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 8, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
7.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

October 16, 2015

Last Update Submit

August 23, 2023

Conditions

Dystrophic Epidermolysis Bullosa

Keywords

Epidermolysis Bullosastem cell

Outcome Measures

Primary Outcomes (1)

  • Area of re-epithelization

    Follow up to 8 weeks

Secondary Outcomes (3)

  • Percentage of a target wound's re-epithelialization

    Every time of visit for follow up to 8 weeks

  • Time taken to re-epithelization

    Over 8 weeks

  • Safety assessed by clinically measured abnormality of laboratory tests and adverse events

    Over 8 weeks

Study Arms (2)

ALLO-ASC-DFU

EXPERIMENTAL
Other: Allogeneic mesenchymal stem cells

Conventional Therapy

ACTIVE COMPARATOR
Device: Polyurethene Film

Interventions

Allogeneic mesenchymal stem cellsOTHER

Dressing for Dystrophic Epidermolysis Bullosa wound.

Also known as: ALLO-ASC-DFU
ALLO-ASC-DFU
Polyurethene FilmDEVICE

Dressing for Dystrophic Epidermolysis Bullosa wound.

Conventional Therapy

Eligibility Criteria

Age10 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age : 10\~60
  • Diagnosed with Dystrophic Epidermolysis Bullosa based on immunofluorescence test.
  • Bullous skin lesion sized over 10 cm\^2
  • Test negative for Serum β-HCG pregnancy test on screening, if the subject is fertile
  • A subject who is willing to follow the protocol and provide a informed consent on screening, given that the information with respect to the clinical trial is provided.

You may not qualify if:

  • A subject with history of epidermoid carcinoma within a year from screening.
  • A subject who requires antibiotics due to bacterial infection on skin.
  • A subject who was dosed with oral steroid, over 0.5mg/kg a day for subjects under 18, or over 20mg in 2 weeks for subjects over 18, within 30 days prior to screening.
  • A subject treated with radiotherapy or immunosuppressants, within 30 days prior to screening.
  • A subject treated with steroids locally, within 30 days prior to screening.
  • A subject with 2-times the maximum-standardized value of ALT, AST, ALP, bilirubin, total protein
  • A subject with 2-times the maximum-standardized value of BUN, Creatinine
  • A subject with Albumin below 2.0 g/dL.
  • A subject with Hemoglobin below 6 g/dL (anemic).
  • A subject with allergic response to bovine derived protein and fibrin glue.
  • A subject administered with biologic agents or cell therapy, within 30 days prior to screening.
  • A subject administered with stem cell treatment by IV or subcutaneously to the target wound, prior to the trial
  • A subject who enrolled into another clinical trial, within 30 days prior to screening
  • A subject with serious disease that can affect on clinical trial.
  • A pregnant or breast-feeding subject.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severence Hospital

Seoul, 135-720, South Korea

Location

MeSH Terms

Conditions

Epidermolysis Bullosa DystrophicaEpidermolysis Bullosa

Condition Hierarchy (Ancestors)

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

Study Officials

  • Su Chan Kim, PhD.

    Gangnam Severence Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2015

First Posted

October 19, 2015

Study Start

December 8, 2015

Primary Completion

April 1, 2016

Study Completion

April 30, 2023

Last Updated

August 25, 2023

Record last verified: 2023-08

Locations

KR(1)