A Clinical Trial to Evaluate the Safety and Efficacy of A... | NCT02619851

Studies
A Clinical Trial to Evaluate the Safety and Efficacy of ALLO-ASC-DFU for Second Deep Degree Burn Injury Subjects

NCT02619851

Sponsor

Anterogen Co., Ltd.

Status

Completed

Last Update Posted

Aug 25, 2023Actual

Enrollment

20Actual

Phase

Phase 2

Conditions

Burn Injury

Interventions

ALLO-ASC-DFU
Conventional Therapy

Countries

South Korea

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

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 23, 2015Actual

Primary Completion Date

Jul 2, 2019Actual

Completion Date

Jul 13, 2021Actual

First Submitted Date

Nov 30, 2015

First Submission Date that Met QC Criteria

Dec 1, 2015

First Posted Date

Dec 2, 2015Estimated

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

Aug 23, 2023

Last Update Posted Date

Aug 25, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This clinical trial is a Phase II controlled, parallel, open-label trial, designed to test the efficacy and safety of ALLO-ASC-DFU and conventional therapy in Deep Second-degree burn wound subjects.

Detailed Description

ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating Deep Second-degree burn wounds.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ALLO-ASC-DFU	Experimental	Allogeneic mesenchymal stem cells	Biological: ALLO-ASC-DFU
Conventional Therapy	Active Comparator	Typical therapy conducted for burn injury patients	Device: Conventional Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ALLO-ASC-DFU	Biological	Dressing for Second Deep degree Burn injury	ALLO-ASC-DFU

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time of re-epithelialization	Time of re-epithelialization	Follow up to 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Safety (laboratory tests and adverse events)	Clinically measured abnormality of laboratory tests and adverse events	Follow up to 12 weeks
Burn Scar Index	Vancouver Burn Scar Scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is 18 years of age and older.
Subjects who have deep second-degree burn wound ≥100cm^2.
TBSA(Total burn surface area) ≤ 30%
Negative for Urine beta-HCG for women of childbearing age.
Subject is able to give written informed consent prior to study start and comply with the study requirements.

Exclusion Criteria:

Subject who have been enrolled in another clinical study within 30 days of screening.
Subjects who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue.
Subjects who are receiving steroids, immunosuppressive, or anticoagulant for long term
Subjects with active infection.
Subjects with hemorrhagic and hemocoagulative disease.
Subjects who are unwilling to use an "effective" method of contraception during the study.
Subjects who have a history of malignant tumor within the last five years, or is currently undergoing.
Subjects who are pregnant or breast-feeding.
Subjects who are considered to have a significant disease which can impact the wound healing by the investigator
Burn wound is present on any part of the face.
Subjects who are considered not suitable for the study by the investigator.
Subjects who are not able to understand the objective of this study or to comply with the study requirements

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided