Suspended

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

What is being tested

Adipose SVF cell

+ Normal saline

Biological

Who is being recruted

Congenital Abnormalities+6

+ Breast Diseases

+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities

From 40 to 60 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Interventional

Study Start: December 2020

See protocol details

Summary

Principal SponsorSeoul National University Hospital

Last updated: October 23, 2020

Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2020

Actual date on which the first participant was enrolled.

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

NCT01801878

Principal SponsorSeoul National University Hospital

Last updated: October 23, 2020

Sourced from a government-validated database.Claim as a partner

Protocol

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

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Female

Biological sex of participants that are eligible to enroll.

From 40 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesBreast DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBreast NeoplasmsSkin Abnormalities

Criteria

4 inclusion criteria required to participate

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

7 exclusion criteria prevent from participating

Pregnant or lactating subjects

Subjects who are not eligible for this study at the discretion of the investigator

Subjects who have a active infectious disease

Subjects who have a history of smoking within 3months recently

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

adipose SVF cell transfer to the half of irradiated breast

Group II

Active Comparator

Normal saline inject to the half of irradiated breast

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Seoul National Univ. Bundang Hospital

Seongnam-si, South KoreaOpen Seoul National Univ. Bundang Hospital in Google Maps

SuspendedOne Study Center