Aesthetics Procedure Clinical Trial
Official title:
Phase I Study of a Filler Agent Composed of Mesenchymal Stem Cells Obtained From Autologous Adipose Tissue Associated With Hyaluronic Acid
Lipodystrophies are part of a clinically heterogeneous group of disorders characterized by
loss (lipoatrophies) and / or accumulation of fat, which usually results in a change of
normal tissue surface. Millions of plastic and reconstructive surgeries are performed
annually to repair soft tissue defects due to trauma, tumor resection and congenital
defects. Surgical options for lipoatrophy, the lipodystrophy type characterized by
subcutaneous adipose tissue atrophy, include: Transfer of autologous fat, Dermis - fat
graft, Skin flaps and Commercially available fillers.
Currently, the most commonly filler agent used for the lipodystrophy treatment is
polymethylmethacrylate, considered permanent and with a history of short- and medium-term
adverse effects. Biocompatible and temporary filler agents such as hyaluronic acid,
polylactic acid and collagen have been used for over 25 years for cosmetic purposes and in
lipoatrophies. More recently, the use of autologous fibroblasts proved to be efficient
solving acne scars and enabling dermis regeneration. Studies in mice showed that the
combination of pre - adipocytes with a biomaterial is much more effective in tissue
reconstitution than the injection of adipose tissue only, providing volume and also
stimulating cell proliferation and differentiation with increased production of
extracellular matrix.
This project aims a phase I clinical trial of a filler agent, composed of mesenchymal stem
cells derived from autologous adipose tissue associated with hyaluronic acid.
Open, controlled and randomized study. The intervention performed in this study will be the
transdermal injection of the filler agent in patients undergoing elective cosmetic
liposuction procedure, with legal age and without any of the exclusion criteria items.
Patients will be evaluated according to the parameters for a total period of 12 months.
Individuals in the control group will have transdermal injection of hyaluronic acid and will
be evaluated with the same parameters used for the study group and also for the same period.
In this study, 25 volunteers attended at Dermatologic Service of the Bonsucesso Federal
Hospital (HFB) will be included.
The research subjects will be evaluated preliminarily regarding inclusion and exclusion
criteria of the study and the procedure will only be performed after the signing of the
Informed Consent Form (ICF).
The efficacy and safety study will be conducted following Good Laboratory and Clinics
Practices.
Patients who meet the study eligibility criteria will be randomly assigned to one of the two
treatment groups: Test or Control.
The first follow-up visit will occur in the first month post-procedure. Subsequent
consultations will be held at 3, 6 and 12 months after the procedure.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment