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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01801878
• Other study ID #: B-1206-158-005
• Secondary ID: 06-2012-193
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: October 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Skin Abnormalities

Intervention

Biological:
• Adipose SVF cell
adipose SVF cell transfer to the half of irradiated breast
• Normal saline
Normal saline inject to the half of irradiated breast

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Univ. Bundang Hospital	Seongnam-si	Bundang,Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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