Facial Atrophy Clinical Trial
Official title:
A Phase II Double-blind, Randomized, Study to Assess the Efficacy of Facial Fat Grafts Supplemented With Autologous, Adipose Derived Stromal Vascular Fraction (SVF)
This phase two, randomized, double-blind study is designed to demonstrate the enhanced efficacy of SVF-enriched autologous facial fat grafts, in relation to standard, non-SVF enriched, facial fat grafts by evaluating volumetric retention and contour of the engrafted region over the course of one year.
Human Adipose Tissue is considered as a new source for Stromal Stem Cells and offers a large
therapeutic potential for many rare and common diseases that impacts millions of patients
worldwide. The Stromal Vascular Fraction (SVF) of Adipose Tissue is relatively easy to
extract with minimally invasive procedures such as elective liposuction in large quantities
and therefore may be a cost effective source for cellular therapies in a wide range of
medical specialties.
The term "Facial Atrophy" describes the lost of subcutaneous fat within the face and can be a
result of the aging process as well as some pathological diseases. It can be corrected via
autologous fat transfer but usually the majority of the grafted cells will die after 6-12
months. Several publications demonstrate that the addition of SVF cells to the graft may
enhance the graft survival.
This double blind, randomized study aims to demonstrated the efficacy of Antria Cell
Preparation Process in autologous facial fat grafting.
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