Clinical Trials Directory

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UnknownNCT02116933

Grafting of Autologous Adipose Stromal Cell Trial

Status
Unknown
Phase
Phase 2
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
Tower Outpatient Surgical Center · Academic / Other
Sex
Female
Age
21 Years – 65 Years
Healthy volunteers
Accepted

Summary

Grafting of autologous stromal cell trial is a prospective study comparing routine fat grafting versus stromal vascular fraction enriched fat grafting.

Detailed description

The purpose of this study is to objectively compare outcomes between autologous fat grafting breast augmentation and stromal vascular fraction enhanced autologous fat grafting for cosmetic breast augmentation in a carefully designed study. Patients will be given the option of participating in one of two studies: 1. A small, level I study will compare AFG to SVF-enriched AFG in the same patient. One breast will be treated with AFG alone (control) and the other breast with SVF-enriched AFG (experimental). 2. A larger, level II study comparing AFG to SVF-enriched AFG in different patients. The patient will either receive AFG alone in both breasts or SVF-enhanced AFG in both breasts.

Conditions

Interventions

TypeNameDescription
PROCEDUREAdipose Derived Stem CellsAdipose derived stem cells harvested from autologous lipoaspirate
PROCEDURESVF Enriched Autologous Fat GraftingCell assisted lipotransfer

Timeline

Start date
2013-03-01
Primary completion
2016-03-01
Completion
2016-03-01
First posted
2014-04-17
Last updated
2015-05-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02116933. Inclusion in this directory is not an endorsement.