Stromal Vascular Fraction injectable as a preventive treatment of scars.

Lipofilling is recognized as a promising and novel technique in plastic
surgery. This is strongly supported by evidence-based clinical trials as well
as fundamental studies in animals and in vitro. The first case of lipofilling
in literature dates from 1893, when Gustav Neuber described the first free fat
transfer for a scar which had left a young man with a soft tissue defect of the
face.The introduction of smaller liposuction and lipofilling cannulas opened
the door for reconstructive purposes for aesthetic application like lipofilling
of the face and hands. Especially in these more superficial cases of
lipofilling, the effects were often described as *more than volume alone*. For
the first time, lipofilling was used as a local therapy, and not only for the
reconstruction of volume. The concept of the use of lipofilling to treat tissue
damage or the consequences of tissue damage, led to the use of lipofilling to
treat scarring as a result of burn wounds and even to alleviate pain after
mastectomy. Support for the statement that lipografting might be more than
volume alone, came with the paper of Zuk et al, describing the adipocyte
stromal or stem cells (ADSCs) in lipoaspirate. Although the use of lipofilling
or ADSCs to treat scars is frequently described in literature, no randomized
clinical trial has ever been performed up to today.

In this study we investigate the potential beneficial effect of Stromal
Vascular Fraction (SVF) injectable containing adipose derived stromal cells
(ADSCs) for preventing scars after mamma reduction. One group will receive SVF
and the other group will receive 0,9% NaCl injection. Every patient will be its
own control as one breast will receive SVF injection, while the other breast
will receive an 0.9% NaCl injection.

We are particularly interested in the SVF injectables, which contains ADSCs.
ADSCs are mesenchymal stem cells from adipose tissue, which can be easily
isolated from lipoaspirate where they probably are adjacent as pericytes or
periadventitial cells to little blood vessels. It is well known that ADSCs can
differentiate into ectodermal, endodermal and mesenchymal differentiated cells.
In animal models specifically designed to study scarring and the fibrotic
disorder of Peyronie*s disease, it is noted that deposition of extracellular
matrix components, such as collagen type I and III and elastin, is decreased
after treatment of scars with ADSCs. Also, collagen fibers present in the scar
area, have better alignment. Functionally, treatment of scars with ADSCs leads
to slightly smaller scars and less scar elevation. Therefore, we think the use
of SVF containing ADSCs as a treatment to prevent scar formation will be
useful.

We trust the results of this study will provide us with new insights in the
possibility of the use of adipose tissue or its substances in the treatment of
fibro-proliferative diseases like Morbus Dupuytren. The large volume of
adipose tissue caused by adipocytes is the main limitation in the use of fat as
a treatment of fibro-proliferative diseases. By using the SVF only, the
limitation caused by volume can be avoided and give the possibility to inject
the SVF in organs or areas with small volumes. Treatments of superficial scars
of the skin are performed easily and the outcome measurements of the treatment
are performed easily as well, without the use of invasive techniques.

To quantify clinical and histological improvements in prevention of scars when
SVF injectable is used as treatment.

Double blind placebo-controlled randomized trial (multicenterresearch).

All patients will receive SVF (0,1 ml per 0,1 cm2 scar surface) in 1 scar of 1
breast (Side A) and 0,9% NaCL (0,1 ml per 0,1 cm2 scar surface) in the other
scar of the breast (Side B). Only the lateral 5 cm of the horizontal scar will
be treated and investigated.

Before the operation the breasts will be photographed in a standardized
fashion. During the operation, 2 0.4 cm biopsies (into the dermal fat layer)
will be taken out of the resected (normal) skin, 1 from each breast. After
every mammareduction there will be some resected skin leftovers. Subjects will
already be under full anesthesia at the time of the first biopsies and
preparation and injection of the SVF injectable and 0,9% NaCl injectable.
After a period of 6 and 12 months postoperative, each participant will complete
the POSAS Questionnaire and scars will be photographs in a standardized
fashion. 2 biopsies (into the dermal fat layer) will be taken on fixed
positions, 1 from each scar of each breast. Each postoperative biopsy will be
taken within the borderline between normal skin and scar, with a maximum size
of 0.4 cm. Subjects will be under local anaesthesia at the time of the second
biopsies. The duration of the follow-up moments is estimated at 30 minutes. The
duration of the operation is estimated at 160 minutes.
Using SVF as treatment has not ever increased health risks nor has showed to
increase adverse events of any kind to this date.