A Study to Evaluate the Safety of ALLO-ASC-DFU in the Sub... | NCT02394873

Studies
A Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Deep Second-degree Burn Wound

NCT02394873

Sponsor

Anterogen Co., Ltd.

Status

Completed

Last Update Posted

Dec 30, 2015Estimated

Enrollment

5Actual

Phase

Phase 1

Conditions

Burn

Interventions

ALLO-ASC-DFU

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

Dec 2015

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

Mar 2015

Primary Completion Date

Aug 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Mar 6, 2015

First Submission Date that Met QC Criteria

Mar 17, 2015

First Posted Date

Mar 20, 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

Dec 28, 2015

Last Update Posted Date

Dec 30, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 is a phase I study to evaluate the safety of ALLO-ASC-DFU for the treatment of deep second-degree burn wound patients. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells 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 a burn.

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Label	Type	Description	Intervention Names
ALLO-ASC-DFU	Experimental		Biological: ALLO-ASC-DFU

Name	Type	Description	Arm Group Labels	Other Names
ALLO-ASC-DFU	Biological	Dressing for second-degree burn wound.	ALLO-ASC-DFU

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability		up to 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Time to reach re-epithelialization of wound	Evaluation of the improvement of wound measured by time to reach re-epithelialization of wound	1, 2, 4 weeks
Vancouver Burn Scar Scale		4 weeks

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 ≥100 cm^2.
Negative for urine beta-HCG for women of childbearing age.
Subject is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

Subjects 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.
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 study by the investigator
Burn wound is present on any part of the face.
Subjects who have a history of surgery for malignant tumor within the last five years (except carcinoma site).
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