Study of Breast Reconstruction with Adipose tissue-derived mesenchymal stem cells (ADSCs) in the Treatment of Patients with Breast Deformities Post-breast Conservation Therapy

Not Applicable

Completed

• Conditions: Patients with Breast Deformities Post-breast Conservation Therapy

• Registration Number: JPRN-jRCT1090220159
• Lead Sponsor: Rie Yamashita

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-08
• Study Completion: 2014-12-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5

Inclusion Criteria

(1) Female with Breast Deformities Post-breast Conservation Therapy
(2) Surgical operation, endoscopic surgery or segmental mastectomy
(3)Clean surgical margins
(4)Presence of sufficient fat volume to liposuction
(5)No use of an artificial breast
(6)No recurrence of cancer and cancer metastasis 12 months prior to enrollment
(7)No evidence of recurrence of cancer in based on Mammogram or MRI prior to enrollment
(8)No history of cancer targeted chemotherapy (except estrogen replacement therapy) in the 12 months preceding enrollment.
(9)A minimum of 1cm soft tissue is available between skin and breast
(10)A minimum of 2/3 of the breast is remaining post breast conservation therapy.
(11)No continuous adhesions of skin to bone > 3cm in diameter
(12)The patient understand the clinical studies, she wishes to treatment and her consent is obtained

Exclusion Criteria

(1)Presence or history of any other known malignancy within 5 years. Possibility of malignant tumors by checking examination.
(2)Current use of anti-cancer therapies or immunosuppressant
(3)Presence of infection disease
(4)Fever (above 38.5 degree)
(5)Presence of serious complications (such as poor control high blood pressure and diabetes, heart disease, lung disease, liver disease, kidney disease, or bleeding tendency )
(6)History of autoimmune disease
(7)History of keloid constitution
(8)Chronic use ( > 7 consecutive days) anticoagulants or NSAIDs within 15 days prior to enrollment.
(9)Life expectancy <= 2 years
(10)30 < Body Mass Index (BMI) < 18.5
(11)History of drug hypersensitivity
(12)Pregnancy, breastfeeding and/or possibility of pregnant
(13)Other, If the doctor (investigator) has to be inappropriate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of volumetric data with 3 D photograph systems

Secondary Outcome Measures

Name	Time	Method
1. Ultra sound, 2. Patient satisfaction survey