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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1090220159

Enrollment

Registered

2014-01-08

Start date

2013-10-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Breast Deformities Post-breast Conservation Therapy

Interventions

Intervention type: Name of intervention:H-RMB Dose form / Japanese Medical Device Nomenclature:OTHER ADSCs Route of administration / Site of application:OTHER Dose per administration:5 ml Dosing frequ

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Evaluation of volumetric data with 3 D photograph systems	—

Secondary

Measure	Time frame
1. Ultra sound, 2. Patient satisfaction survey	—

Countries

Japan

Contacts

Public ContactAyako Onoue

Shonan Kamakura General Hospital

a_onoue@shonankamakura.or.jp+81-467-46-1717

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026