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Clinical Trials/NCT01756092
NCT01756092WithdrawnNot Applicable

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

University of Pittsburgh1 site in 1 countryStarted: July 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
Breast Tissue Volume/Appearance (Graft Retention)

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Autologous Fat Graft

Experimental

Participants will receive an autologous fat graft to correct either a benign breast deformity or a post segmental mastectomy deformity.

Intervention: Autologous Fat Graft (Procedure)

Outcomes

Primary Outcomes

Breast Tissue Volume/Appearance (Graft Retention)

Time Frame: Through 12 months following procedure

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.

Secondary Outcomes

  • Patient Satisfaction(6 months after procedure)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

J. Peter Rubin, MD

Principal Investigator

University of Pittsburgh

Study Sites (1)

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