Breast Cancer Clinical Trial
Official title:
Treatment of Benign Breast Deformities and Post-Segmental Mastectomy Breast Deformities With Autologous Fat Grafting (AFT)
The investigators will assess changes in breast appearance, graft retention and quality of life over one year in patients who have received direct autologous adipose tissue injection for the treatment of objectionable post-surgical breast deformities. These patients have undergone the resection of breast tissue to treat either benign or malignant breast disease.
During the past decade there has been increased awareness of the potential of free adipose
cell grafting to treat a variety of problems in both reconstructive and cosmetic plastic
surgery. There have been encouraging reports describing the use of autologous fat grafts
(fat tissue harvested by standard liposuction techniques in a given patient and then
re-injected at another site) for treating breast deformities in the setting of benign and
previously treated malignant breast problems.
There has been a corresponding large scale laboratory investigation effort into the
potential of adipose derived stem cells (ADSC's) harvested during liposuction and induced to
differentiate into various cell types in the mesenchymal cell line. The potential clinical
utility of these cells in the treatment of patients who present with a breast deformity
after segmental mastectomy (lumpectomy) and radiation therapy has been described, but not
studied in rigorous prospective manner.
The investigators believe that the clinical use of these autologous fat cell grafts have
unique advantages in the treatment of breast deformities. The technique is minimally
invasive, easily repeated and is associated with minimal surgical morbidity (indeed it may
have the advantage of improving the appearance of both the breast deformity and the area
from which they are harvested), it typically displays a rapid recovery, a complication rate
that is no greater (and probably less than ) established and currently used surgical
treatment(s) of these breast problems, and is oncologically safe.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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