This study will include patients with genetic predisposition to development of breast cancer, who are offered prophylactic bilateral skin-sparring mastectomy. MedDRA version: 20.0 Level: PT Classification code 10071981 Term: BRCA2 gene mutation System Organ Class: 10018065 - General disorders and administration site conditions MedDRA version: 20.0 Level: PT Classification code 10071980 Term: BRCA1 gene mutation System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Interventions
Product Name: Autologous adipose-derived stem cells
Pharmaceutical Form: Living tissue equivalent
Pharmaceutical form of the placebo: Living tissue equivalent
Route of administration of the placebo: S
Sponsors
Department of Plastic Surgery, Breast and Burns Treatment
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 25 - 45 years (25 and 45 included) 2. Females who are offered prophylactic, bilateral nipple-sparring mastectomy due to an estimated familial predisposition to develop breast cancer. 3. Patients who are deemed fit for breast reconstruction with fat grafting by a plastic surgeon in terms of available fat supply, breast symmetry and small, non-ptotic breast mound. 4. Signed informed consent by the patient 5. Mutual agreement on acceptable breast volume for point of complete reconstruction between patient and surgeon. 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 10 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. Diabetes or other comorbidities that may increase the risk of surgical complications assessed by the surgeon. 3. Genetic syndromes associated with high risk of cancers other than breast- and ovarian cancer. 4. Previous- or planned radiotherapy. 5. Asymmetry of the breasts or thorax. 6. Pacemaker or other implanted foreign objects in the vicinity of the breast.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The addition of ex-vivo expanded Adipose Derived-Stem Cells (ASC) can improve volume retention of fat grafts for breast reconstruction following mastectomy. ;Secondary Objective: It is hypothesized that the improvement of fat graft volume retention can decrease the number of treatments needed for complete reconstruction. ;Primary end point(s): Graft retention of the total volume of injected grafts one year after the final reconstructive procedure, determined by MRI of the breast.;Timepoint(s) of evaluation of this end point: Six months and one year after complete reconstruction of the breasts. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number of treatments needed for complete breast reconstruction. 2. Radiological changes in the breast after conventional and stem cell-enriched fat injection based on MRI one year after ended treatment with fat grafting to the breast. 3. Graft retention rate of the first, second and any subsequent grafting sessions. ;Timepoint(s) of evaluation of this end point: Six months and one year after complete reconstruction of the breasts. | — |
Countries
Denmark
Contacts
Public ContactCopenhagen University Hospital RH
Department of Plastic Surgery, Breast Surgery and Burns Treatment
Outcome results
None listed