Prospective trial of Adipose-Derived Regenerative Cell (ADRC)-enriched fat grafting for partial mastectomy defects: The RESTORE-2 trial

Pérez-Cano R, Vranckx JJ, Lasso JM, et al (Hospital General Universitario Gregorio Maranon, Madrid, Spain; KU Leuven Univ Hosp, Belgium; et al) Eur J Surg Oncol 38:382-389, 2012^§

Abstract

Aims

Women undergoing breast conservation therapy (BCT) for breast cancer are often left with contour defects and few acceptable reconstructive options. RESTORE-2 is the first prospective clinical trial using autologous adipose-derived regenerative cell (ADRC)-enriched fat grafting for reconstruction of such defects. This single-arm, prospective, multi-center clinical trial enrolled 71 patients post-BCT with defects ≤150 mL.

Methods

Adipose tissue was collected via syringe lipoharvest and then processed during the same surgical procedure using a closed automated system that isolates ADRCs and prepares an ADRC-enriched fat graft for immediate re-implantation. ADRC-enriched fat graft injections were performed in a fan-shaped pattern to prevent pooling of the injected fat. Overall procedure times were less than 4 h. The RESTORE-2 protocol allowed for up to two treatment sessions and 24 patients elected to undergo a second procedure following the six month follow-up visit.

Results

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