Document Detail


Prospective trial of adipose-derived regenerative cell (ADRC)-enriched fat grafting for partial mastectomy defects: the RESTORE-2 trial.
MedLine Citation:
PMID:  22425137     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
R Pérez-Cano; J J Vranckx; J M Lasso; C Calabrese; B Merck; A M Milstein; E Sassoon; E Delay; E M Weiler-Mithoff
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Publication Detail:
Type:  Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't     Date:  2012-03-15
Journal Detail:
Title:  European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology     Volume:  38     ISSN:  1532-2157     ISO Abbreviation:  Eur J Surg Oncol     Publication Date:  2012 May 
Date Detail:
Created Date:  2012-04-02     Completed Date:  2012-05-16     Revised Date:  2012-12-28    
Medline Journal Info:
Nlm Unique ID:  8504356     Medline TA:  Eur J Surg Oncol     Country:  England    
Other Details:
Languages:  eng     Pagination:  382-9     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 Elsevier Ltd. All rights reserved.
Affiliation:
Hospital General Universitario Gregorio Maranon, Madrid, Spain.
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MeSH Terms
Descriptor/Qualifier:
Adipocytes / transplantation*
Adult
Aged
Breast Neoplasms / surgery*
Carcinoma, Ductal, Breast / surgery
Female
Humans
Injections
Mammaplasty / methods*
Mastectomy, Segmental / adverse effects*
Mesenchymal Stem Cell Transplantation / methods
Middle Aged
Prospective Studies
Subcutaneous Fat / cytology,  transplantation*
Treatment Outcome
Comments/Corrections
Comment In:
Eur J Surg Oncol. 2012 Dec;38(12):1231-2; author reply 1233-4   [PMID:  22940438 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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