Investigation of efficacy and safety of fat transfer for breast augmentation with the addition of autologous blood cells

Phase 1

• Conditions: Fat grafting e.g. to the breast to restore small tissue defects is a very common and safe surgical procedure. Its main success among other is depended on the survival rate of the transferred fat tissue. The survival rate is very unpredictable and varies from 16-70%. This study will examine impact of autologous PRP-Lysate as a enrichment to fat grafts with the assumption to enhance the survival rate.; MedDRA version: 20.0 Level: PT Classification code 10016251 Term: Fat tissue increased System Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2017-004319-37-AT
• Lead Sponsor: Medical University of Vienna, Department of Surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-20
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

-Female age 18 to 45
-BMI between 21-28
-Candidate for bilateral primary breast augmentation – wish to augment breasts
-Breast cup size at least B
-Patient is eligible to undergo MRI (i.e., no implanted metal or metal devices, no history of severe claustrophobia)
-Sufficient knowledge of German or English language to understand trial instructions and ability to comply with treatment
-The patient has realistic expectations of surgical results after discussion with investigator and is an acceptable candidate for breast augmentation towards investigator judgment
-Adequate peripheral vein status for pheresis
-Written on informed consent prior to enrolment
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 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-History or current diagnosis of breast cancer
-Women undergoing reconstructive surgery following mastectomy
-History of cancer (except non-melanoma skin cancer, or carcinoma in situ of cervix) within the previous two years
-Pregnancy or breast feeding at time of screening
-Patients with scarred breast tissue, with breast size asymmetry reflected in different breast holder size cups
-Women with current infection requiring systemic antibiotic treatment
-Known alcohol, drug or medication abuse
-The patient participated in an interventional trial within 90 days of enrolment
-The patient has a severe breast and upper trunk deformity
-The patients is not willing to undergo further surgery for revision, if medically required
-Use of any immunosuppresive or immunomodulatiry treatment, chronic use of oral or systemic anticoagulation or antiplatelet therapy
-Patients with platelet disorders, thrombocytopenia, bone marrow aplasia
-Any clinically relevant concomitant condition that could compromise the objectives of this study and/ or the patient’s compliance (eg. Patients with diabetes mellitus under treatment, end-stage renal disease and patients on dialysis, patients with severe cardiovascular condition requiring chronic treatment)
-Laboratory criteria: hemoglobin < 12g/dl, CRP > 5mg/dl, platelets < 150 or > 400 tsd./µl, leucocytes < 4,4 or > 11,3 tsd./µl
-Blood donation within 4 weeks before study initiation
-Patients with connective tissue disease OR is currently being evaluated for symptoms suggestive of connective tissue disease
-Any other condition the investigator believes would interfere with the patient’s ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the patient at undue risk

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified