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

October 21, 2020 updated by: Seoul National University Hospital
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

10 participants who taken conservative mastectomy will be enrolled

  1. 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.

  2. Duration of study

    • entire duration: approximate 30weeks
    • Follow-up period: 12 weeks
    • Enrollment period: 12 weeks
  3. Study design - Randomized, prospective, pilot study

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Bundang,Gyeonggi-do
      • Seongnam-si, Bundang,Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National Univ. Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adipose SVF cell
adipose SVF cell transfer to the half of irradiated breast
Biological: Adipose SVF cell
adipose SVF cell transfer to the half of irradiated breast
Active Comparator: Normal saline
Normal saline inject to the half of irradiated breast
Biological: Normal saline
Normal saline inject to the half of irradiated breast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in the breast skin thickness of the pre and post SVF graft from baseline at 12week after procedure
Time Frame: change in the breast skin thickness from baseline at 12 week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

October 30, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

February 27, 2013

First Submitted That Met QC Criteria

February 28, 2013

First Posted (Estimate)

March 1, 2013

Study Record Updates

Last Update Posted (Actual)

October 23, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1206-158-005
  • 06-2012-193 (Other Identifier: HurimBiocell, Inc)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Neoplasms

Clinical Trials on Adipose SVF cell

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe