Lipodystrophy Clinical Trial
Official title:
Potential of Mesenchymal Stem Cell Enriched Adipose Tissue Grafting for Contour Deformities of Face
Contour deformity of face causes both functional as well as aesthetic problems for the patient. Fat being an autologous tissue source is considered as an ideal soft-tissue filler because it is abundant, readily available, inexpensive, host compatible, and can be harvested easily and repeatedly. However absorption of grafted fat is a major problem resulting in lack of consistency of final clinical outcome. Adipose tissue derived mesenchymal stem cells have the potential to enhance the viability of the grafted fat and the reliability of the final outcome of surgery. In the current study potential of mesenchymal stem cells will be studied by comparing two groups of patients requiring fat grafting for contour deformities of face. Control group will have fat graft with out enrichment with stem cells whereas experimental group will have their fat graft enriched with mesenchymal stem cells. Comparison will be made regarding viability of grafted fat in two groups.
Contour deformities of the face requiring soft tissue augmentation often result from
conditions such as congenital disorders, acquired diseases, and traumatic and developmental
deformities. Significant contour deformity of face causes both functional as well as
aesthetic problems for the patient. Conventionally, these problems are treated by allogenic
fillers, major flap surgery and fat grafting.1 However; different problems are associated
with above mentioned treatment options. For example, allogenic fillers are foreign material
that poses not only allergic reactions but also rapid absorption at the site of application.
Similarly, flap surgery, in the form of pedicled and free flaps, produces considerable donor
site morbidity. In addition, fine- tuning is impossible with flap, and tissue transferred in
the form of flap may act as blob.
Autologous fat grafting has gained pervasive acceptance for the management of contour
deformities of the face. Fat being an autologous tissue source is considered as an ideal
soft-tissue filler because it is abundant, readily available, inexpensive, host compatible,
and can be harvested easily and repeatedly.2 Although the practice of fat grafting is not
new and it is a safe and natural method of soft-tissue augmentation, the viability and
reliability of transplanted fat grafts remains poorly studied. One major concern is the lack
of consistency of final clinical outcome, which often requires multiple fat grafting
procedures making it expensive. Rate of fat absorption may reach up to 40% to 80%.However,
previously published data have failed to produce a cohesive algorithm of the required
components for successful, consistent and durable fat transplantation.3 In order to overcome
problems associated with fat grafting, other innovative techniques are required.
The role of fat auto-transplantation in plastic surgery has evolved from a controversial
technique designed for simple volume augmentation to the foundation for the innovative and
burgeoning field of regenerative medicine. This is based on the fact that adipose tissue
contains adipocytes and the stromal vascular fraction (SVF) consisting of multiple cell
types such as circulating blood cells, fibroblasts, pericytes, endothelial cells, and
mesenchymal stem cells (MSCs). Adipocytes account for 20 percent or fewer of the total
number of cells in adipose tissue4whereasthere are only 3% MSCs in SVF of adipose tissue.5
Although this percentage is relatively low, this cell type is the main contributor in
overall healing process. MSCs derived from adipose tissue (AT-MSCs) have high proliferative
potential and ability to differentiate into mesenchymal (adipose, bone, cartilage) and
non-mesenchymal (neuron like cells) lineages.6,7,8 AT-MSCs have been shown to enhance
angiogenesis, decrease apoptosis and modify the local inflammatory response owing to their
immunosuppressive and immunomodulatory properties.9 Therefore, the current study is designed
to evaluate the effect of fat grafting and AT-MSCs together on contour deformities of face.
By combining traditional fat graft with AT-MSCs, tissue viability and therefore the
consistency of graft survival may be improved. In the current model investigators propose
that transferred fat may act as a natural scaffold and temporary filler to restore the
volume immediately while AT-MSCs will start participating in multiple parameters of tissue
regeneration. This model supports the "host replacement theory" that has been put forward to
describe how fat grafts survive after they are transplanted.10 Due to problems associated
with fat grafting alone, it is desirable to solve such issues by using innovating
techniques. In the current study investigators propose the novel idea of enrichment of
conventional fat graft with ex-vivo expanded AT-MSCs to enhance the viability of the grafted
fat and the reliability of the final outcome of surgery. Recent animal studies have
suggested that AT-MSCs that have been expanded before administration could help preserve
grafted fat and improve outcomes.11 Thus rationale of current study is to compare the
outcome of conventional fat grafting with stem cell enriched fat grafting for contour
deformities of face. If enrichment of fat graft with AT-MSCs can decrease its absorption
rate, this innovative strategy can make fat transfer a reliable option for soft tissue
augmentation. This can definitely improve final clinical outcome at lesser cost and reduced
donor site morbidity
;
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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