Fat transplantation enriched with expanded adipose-derived autologous mesenchymal stem cells in reconstruction of the breast.
- Conditions
- The study will include participants with breast hypoplasia (International Classification of Diseases-10: DQ 838A).MedDRA version: 20.0Level: PTClassification code 10049070Term: Breast hypoplasiaSystem Organ Class: 10038604 - Reproductive system and breast disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2014-000510-59-DK
- Lead Sponsor
- Dept of Plastic Surgery, Breast Surgery & Burns
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 14
1.Age 30 - years (incl. 30 and 45)
2.Healthy females
3.BMI 22 - 30 kg/m2 (incl. 20 and 30)
4.1500 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs
5.Desire for breast augmentation with 300 ml in each breast
6.Symmetric breast hypoplasia
7.Speaks and reads Danish
8.Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Smoking
2.Previous abdominal surgery or breast surgery
3.Previous cancer or known breast cancer predisposition
4.Pregnancy or planned pregnancy within one year after the procedure
5.Breastfeeding less than 6 months prior to inclusion
6.Known chronic disease
7.Pacemaker or other implanted foreign objects
8.Allergy towards necessary anaesthesia
9.Current or previous participation in other medical studies
10.Withdrawal of informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method