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Treatment of Benign Breast Deformities and Post-Segmental Mastectomy Breast Deformities With Autologous Fat Grafting (AFT)

18 Years
70 Years
Not Enrolling
Breast Cancer, Lumpectomy, Mastectomy, Segmental

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Trial Information

Treatment of Benign Breast Deformities and Post-Segmental Mastectomy Breast Deformities With Autologous Fat Grafting (AFT)

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.

Inclusion Criteria:

- Age 18 through 70 years of age inclusive and able to provide informed consent and

- Subject is 6 months post chemotherapy or radiation treatment and is scheduled for
physician evaluation for a standard of care breast fat graft procedure.

- Per PI's discretion is stable post-surgery or who has a benign breast deformity or
post segmental breast deformity

- Willing and able to comply with the study schema for research procedures.

Exclusion Criteria:

Age less than 18 years

- Inability to provide informed consent

- Active chemotherapy or radiation therapy treatment for cancer diagnosis

- Not clinically stable to have a surgical intervention

- Active infection anywhere in the body

- Known coagulopathy

- Pregnancy

- Per the PI's discretion, subject is not a candidate for participation in this
clinical trial.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Breast Tissue Volume/Appearance (Graft Retention)

Outcome Description:

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.

Outcome Time Frame:

Through 12 months following procedure

Safety Issue:


Principal Investigator

J. Peter Rubin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Institutional Review Board

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Breast Cancer
  • Lumpectomy
  • Mastectomy, Segmental
  • Breast Cancer
  • Lumpectomy
  • Mastectomy, Segmental
  • Congenital Abnormalities
  • Breast Neoplasms



UPMC Center for Innovation in Restorative Medicine Pittsburgh, Pennsylvania  15213