The study will include participants with breast hypoplasia (International Classification of Diseases-10: DQ 838A). MedDRA version: 20.0 Level: PT Classification code 10049070 Term: Breast hypoplasia System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Product Name: Autologous adipose-derived stem cells
Pharmaceutical Form:
Other descriptive name: EXPANDED HUMAN AUTOLOGOUS MESENCHYMAL ADULT STEM CELLS EXTRACTED FROM ADIPOSE TISSUE (EASCS)
Concentra
Sponsors
Dept of Plastic Surgery, Breast Surgery & Burns
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the trial is to examine whether enrichment of a fat graft with autologous ASC injected into the breast tissue using traditional technique of ‘small aliquot-injection’ will significantly improve take of the graft and the result of a breast augmentation. The trial will compare fat grafting enriched with ex vivo expanded stem cells to the conventional fat grafting. ;Secondary Objective: Screening of radiological changes in the breast after conventional and stem cell-enriched fat injection as based on MRI and mammography. ;Primary end point(s): Measurement of residual volume of fat transplants as based on MRI one year after lipoinjection to the breast. ;Timepoint(s) of evaluation of this end point: The MRI examinations will be performed prior to surgery, immediately after surgery (maximum 30 min) and after 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Measurement of residual volume of fat transplants as based on MRI four months after lipoinjection to the breast. 2. Radiological changes in the breast after conventional and stem cell-enriched fat injection as based on MRI four months after lipoinjection to the breast. 3. Radiological changes in the breast after conventional and stem cell-enriched fat injection as based on MRI one year after lipoinjection to the breast. 4. Radiological changes in the breast after conventional and stem cell-enriched fat injection as based on mammography one year after lipoinjection to the breast. 5. Possible adverse events that do not normally occur in relation to fat grafting to the breast and are not described in the risk assessment of this study. ;Timepoint(s) of evaluation of this end point: The MRI and physical examinations will be performed prior to surgery, immediately after surgery (maximum 30 min) and after 4 and 12 months. Mammography will be performed one month prior to surgery and 12 months after surgery. | — |
Countries
Denmark
Contacts
Public ContactRigshospitalet
Dept of Plastic Surgery, Breast Surgery & Burns
Outcome results
None listed