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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01756092
Recruitment Status : Withdrawn (Because funding was not secured, the study was never initiated. 0 subjects enrolled)
First Posted : December 24, 2012
Last Update Posted : October 21, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Breast Cancer Lumpectomy Mastectomy, Segmental Procedure: Autologous Fat Graft

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  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Benign Breast Deformities and Post-Segmental Mastectomy Breast Deformities With Autologous Fat Grafting (AFT)
Study Start Date : July 2011
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Autologous Fat Graft
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.

Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Patient Satisfaction [ Time Frame: 6 months after procedure ]
    Measure patient satisfaction with use of quality of life questionnaires (SF-36 and BREAST-Q) before and after autologous fat grafting.

Other Outcome Measures:
  1. Assess Cellular Properties of Graft [ Time Frame: Sample collected at time of procedure ]

    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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01756092

United States, Pennsylvania
UPMC Center for Innovation in Restorative Medicine
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: J. Peter Rubin, MD University of Pittsburgh
More Information

Rigotti, G. Oncologic Safety of Adipose Derived Stem Cell Grafts in the Treatment of Post-Lumpectomy Patients. Presented at the 88th Annual Meeting of the American Society of Plastic Surgeons

Responsible Party: J. Peter Rubin, MD, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01756092     History of Changes
Other Study ID Numbers: PRO10020385
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016

Keywords provided by J. Peter Rubin, MD, University of Pittsburgh:
Breast Cancer
Mastectomy, Segmental

Additional relevant MeSH terms:
Congenital Abnormalities