Grafting of Autologous Adipose Stromal Cell Trial — GAASC  

Micromastia Clinical Trial

Official title: Grafting of Autologous Adipose Stromal Cell Trial

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Micromastia

• NCT number: NCT02116933
• Study type: Interventional
• Source: Tower Outpatient Surgical Center
• Contact: Cloe S Hakakian, BS
• Phone: 3106590705
• Email: cloe@aronowitzmd.com
• Status: Recruiting
• Phase: Phase 2
• Start date: March 2013
• Completion date: March 2016