An interventional study of Autologous Fat Graft in Breast Cancer, Lumpectomy and Mastectomy, Segmental, sponsored by University of Pittsburgh. Withdrawn at 1 site in United States. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-10-21.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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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Exclusion Criteria:
Age less than 18 years
Participants will receive an autologous fat graft to correct either a benign breast deformity or a post segmental mastectomy deformity.
Procedure: Autologous Fat Graft
Participants will receive an autologous fat graft to correct either a benign breast deformity or a post segmental mastectomy deformity.
Breast Tissue Volume/Appearance (Graft Retention)
Assess breast appearance and soft tissue volume before and after autologous fat grafting utilizing 2D / 3D digital photography and a physician rating scale to determine graft retention through 12 months following fat grafting procedure.
Time frame: Through 12 months following procedure
Patient Satisfaction
Measure patient satisfaction with use of quality of life questionnaires (SF-36 and BREAST-Q) before and after autologous fat grafting.
Time frame: 6 months after procedure
Assess Cellular Properties of Graft
Preadipocyte yield: The number of cells isolated per gram of adipose tissue will be determined using a hemacytometer. Preadipocyte Viability: Cell viability will be determined using the Live/Dead assay. Preadipocyte Proliferation: Cellular proliferation of preadipocytes will be assessed with the CyQUANT Cell Proliferation Assay Kit (Invitrogen, Carlsbad, CA) at 48 and 96 hours. Preadipocyte Differentiation: The assessment of the potential of the preadipocytes to differentiate into adipogenic cell types will be assessed
Time frame: Sample collected at time of procedure
This study is withdrawn, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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