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

NCT01801878 | Withdrawn

• 2 other identifiers: B-1206-158-00506-2012-193
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Skin Abnormalities

Keywords

breast cancer; loss of elasticity in irradiated breast skin; Other Reconstructive Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Adipose SVF cell BIOLOGICAL

adipose SVF cell transfer to the half of irradiated breast

Adipose SVF cell

Normal saline BIOLOGICAL

Normal saline inject to the half of irradiated breast

Normal saline

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National Univ. Bundang Hospital

Seongnam-si, Bundang,Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms; Skin Abnormalities

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Chanyeong Heo, Ph.D

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2013
• First Posted: March 1, 2013
• Study Start: December 1, 2020
• Primary Completion: October 30, 2021
• Study Completion: December 30, 2021
• Last Updated: October 23, 2020

Record last verified: 2020-10

Locations

KR (1)