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
Of the 67 patients treated, 50 reported satisfaction with treatment results through
12 months. Using the same metric, investigators reported satisfaction with 57 out
of 67 patients. Independent radiographic core laboratory assessment reported improvement
in the breast contour of 54 out of 65 patients based on blinded assessment of MRI
sequence. There were no serious adverse events associated with the ADRC-enriched fat
graft injection procedure. There were no reported local cancer recurrences. Injection
site cysts were reported as adverse events in ten patients.
Conclusion
This prospective trial demonstrates the safety and efficacy of the treatment of BCT
defects utilizing ADRC-enriched fat grafts.
Keywords
Abbreviations:
BCT (breast conservation therapy), ADRC (adipose-derived regenerative cells)To read this article in full you will need to make a payment
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Article info
Publication history
Accepted:
February 27,
2012
Identification
Copyright
© 2012 Elsevier Ltd. Published by Elsevier Inc. All rights reserved.
