NCT02526576: SVF

A Phase II Double-blind, Randomized, Study to Assess the Efficacy of Facial Fat Grafts Supplemented With Autologous, Adipose Derived Stromal Vascular Fraction (SVF)

Completed Phase 2 Last updated 25 February 2019

What this trial tests

Phase 2 trial testing Stromal Vasular Fraction in Facial Atrophy in 34 participants. Completed in 1 July 2017.

Timeline

1 August 2015

Primary endpoint
1 July 2017

1 July 2017

Quick facts

Lead sponsor	Antria
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	34
Start date	1 August 2015
Primary completion	1 July 2017
Estimated completion	1 July 2017
Sites	1 location across United States

Drugs / interventions tested

• Stromal Vasular Fraction — full drug profile →
• Biopsy — full drug profile →

Conditions studied

• Facial Atrophy — all drugs for Facial Atrophy →

Sponsor

Antria — full company profile →

Who can join

Adults 18 to 70, any sex, with Facial Atrophy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Volume retention
  Time frame: 12 months
  To demonstrate that SVF administration, in concert with autologous facial fat grafts, is more efficacious, with regards to graft survival, than standard, non-SVF enhanced, autologous facial fat grafts

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mesenchymal Stem Cells from Adipose Tissue in Clinical Applications for Dermatological Indications and Skin Aging.
   Gaur M, Dobke M, Lunyak VV. · · 2017 · cited 105× · PMID 28117680 · DOI 10.3390/ijms18010208
2. Concise Review: Fat and Furious: Harnessing the Full Potential of Adipose-Derived Stromal Vascular Fraction.
   Dykstra JA, Facile T, Patrick RJ, Francis KR, et al · · 2017 · cited 77× · PMID 28186685 · DOI 10.1002/sctm.16-0337
3. The use of stem cells in aesthetic dermatology and plastic surgery procedures. A compact review of experimental and clinical applications.
   Nowacki M, Kloskowski T, Pietkun K, Zegarski M, et al · · 2017 · cited 7× · PMID 29422816 · DOI 10.5114/ada.2017.72456