臨床研究等提出・公開システム

Safety and efficacy of cultured adipose-derived stem cells for breast-reconstruction after breast conserving surgery with radiation (CABCR)

Cultured adipose-derived stem cells for breast reconstruction (CAB)

Sawamura Shigehito

Oct. 30, 2023

0

No patients received the regenerative medice with this study protocol.

This study has been terminated before the patient registration and no data were collected.

This study has been terminated before the patient registration and no data were collected.

This study has been terminated before the patient registration and no data were collected.

This study was planned to assess safety and efficacy of cultured adipose-redived stem cells for breast-reconstruction after breast conserving surgery with radiation; however, the study has been terminated before the patient registration and no data were collected.

No

https://jrct.mhlw.go.jp/latest-detail/jRCTb030230126

Komuro Yuzou

Teikyo University School of Medicine

2-11-1 Kaga Itabashi-ku Tokyo 173-8606

ykomuro@med.teikyo-u.ac.jp

Uno Kiyoko

Teikyo University School of Medicine

2-11-1 Kaga Itabashi-ku Tokyo 173-8606

+81-3-3964-1211

kiyoko.uno@med.teikyo-u.ac.jp

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Patients who meet all of the following conditions:
1) Female, age 20 years and older
2) Primary breast cancer in one side
3) Anticipate reconstruction for breast deformity after breast-conserving surgery followed by radiation therapy
4) Last surgery for breast cancer more than 1 year prior to enrollment
5) No metastasis, residual or local recurrence, and no evidence of recurrence of cancer
6) Available adipose tissue collection with inhalation technique
7) Signed written informed consent

Patients who meet any of the following conditions:
1) Not enough adipose tissue collection
2) Not controlled infectious diseases
3) Evidence of infection in treatment target area and adipose tissue collection site
4) History of breast augmentation in affected side
5) Presence of any other known malignancy or metastasis
6) Use of anticancer, immunosuppressant, anticoagulant or antiplatelet agents during this research, from first adipose tissue collection to 18-month follow-up
7) Surgery or radiation therapy in treatment target area and adipose tissue collection site during this research, from first adipose tissue collection to 18-month follow-up
8) Considered by investigator due to any other severe condition such as cardiac, lung, liver, kidney, auto-immune, not-controlled diabetes, or drug allergy
9) Pregnant or breast-feeding
10) Smoker or unavailable to quit smoking during this research, from first adipose tissue collection to 18-month follow-up
11) Not appropriate or not consent obtained for general anesthesia
12) Lack of cooperation with the procedures designated for this research
13) Considered as inappropriate for this research for any reason by investigators

Female

Breast deformity after breast-conserving surgery followed by radiation therapy

1) Adipose tissue collection with inhalation technique
2) Administration of autologous adipose-derived stem cells and adipose tissue with cultured cells

Number and Grade (CTCAR v5.0-JCOG) of adverse events related to this research from day 0 to 18 months follow-up

- Comparison of affected and unaffected breasts in percent change of elasticity measured by ultrasonic elastography
- Change in breast subcutaneous tissue thickness and breast volume measured by ultrasonography and breast MRI
- Patient reported outcome on health related quality of life evaluated with Breast Q

Complete

+81-3-5772-7584

Mar. 20, 2023