Pilot Study of Skin Quality Improvement After Adipose-dri... | NCT01801878

Studies
Pilot Study of Skin Quality Improvement After Adipose-drived Stem Cell Transfer in Irradiated Breasts

NCT01801878

Sponsor

Seoul National University Hospital

Status

Withdrawn

Last Update Posted

Oct 23, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Breast Neoplasms
Skin Abnormalities

Interventions

Adipose SVF cell
Normal saline

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

ID	Type	Description	Link
06-2012-193	Other Identifier	HurimBiocell, Inc

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty in recruiting research subjects

Expanded Access Info

Start Date

Dec 1, 2020Estimated

Primary Completion Date

Oct 30, 2021Estimated

Completion Date

Dec 30, 2021Estimated

First Submitted Date

Feb 27, 2013

First Submission Date that Met QC Criteria

Feb 28, 2013

First Posted Date

Mar 1, 2013Estimated

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

Oct 21, 2020

Last Update Posted Date

Oct 23, 2020Actual

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

The aim of this study is to evaluate the skin quality of using adipose-drived stromal vascular fraction (SVF) cell taken by automatic centrifuge for adipose-drived cell isolation system into irradiated breasts.

Detailed Description

10 participants who taken conservative mastectomy will be enrolled

Process
- adipose tissue is obtained from the subject's thigh or abdomen
- adipose-drived stromal vascular fraction(SVF)cell isolation using automatic centrifuge system
- adipose-drived stromal vascular fraction(SVF)cell graft into the irradiated breast.
Duration of study
- entire duration: approximate 30weeks
- Follow-up period: 12 weeks
- Enrollment period: 12 weeks
Study design - Randomized, prospective, pilot study

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adipose SVF cell	Experimental	adipose SVF cell transfer to the half of irradiated breast	Biological: Adipose SVF cell
Normal saline	Active Comparator	Normal saline inject to the half of irradiated breast	Biological: Normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adipose SVF cell	Biological	adipose SVF cell transfer to the half of irradiated breast	Adipose SVF cell

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change in the breast skin thickness of the pre and post SVF graft from baseline at 12week after procedure	The efficacy is assessed by breast skin thickness measured by radiologist using breast ultrasonography	change in the breast skin thickness from baseline at 12 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female aged between 40 and 60
Subjects who diagnosed breast ductal carcinoma in situ of surgical staging T1aN0, negative resection margin of below 2mm in histopathologic examination
Subjects who have a relapse-free interval of more than one year after breast-conserving surgery for breast cancer and radiation therapy
Subjects who understand the study contents and sign the informed consent

Exclusion Criteria:

Subjects who have radiodermatitis
Subjects who planned breast reconstruction with autogenous tissue (ex.Transverse Rectus Abdominis Muscle flap)
Subjects who have a history of smoking within 3months recently
Subjects who participated in other clinical trial within 30 days recently
Pregnant or lactating subjects
Subjects who have a active infectious disease
Subjects who are not eligible for this study at the discretion of the investigator

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chanyeong Heo, Ph.D	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National Univ. Bundang Hospital		Seongnam-si	Bundang,Gyeonggi-do	463-707	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D012868	Skin Abnormalities

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077330	Saline Solution

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided