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Adipose Derived Stem Cells in Facial Fat Grafting

NCT02526576 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-02-27

No results posted yet for this study

Summary

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.

Conditions

  • Facial Atrophy

Interventions

BIOLOGICAL

Stromal Vasular Fraction

The stromal vascular fraction obtained from adipose tissue will be added to the graft

PROCEDURE

Biopsy

A subgroup of each arm (2 subjects from each arm) will undergo a fat transfer behind each ear to be removed via biopsy after 12 months

Sponsors & Collaborators

  • Antria

    lead INDUSTRY

Principal Investigators

  • Shahram Rahimian, MD · Antria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02526576 on ClinicalTrials.gov