Clinical trial NCT01756092: Treatment of Benign Breast Deformities and Post-Segmental Mastectomy Breast Deformities With Autologous Fat Grafting (AFT)
Official title: Treatment of Benign Breast Deformities and Post-Segmental Mastectomy Breast Deformities With Autologous Fat Grafting (AFT)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Lumpectomy
Mastectomy, Segmental
Keywords: Breast Cancer
Lumpectomy
Mastectomy, Segmental
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2012-12-24
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Breast Tissue Volume/Appearance (Graft Retention)
timeFrame: Through 12 months following procedure
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 6 months after procedure
Other outcomes:
measure: Assess Cellular Properties of Graft
timeFrame: Sample collected at time of procedure
Locations:
city: Pittsburgh
country: United States
facility: UPMC Center for Innovation in Restorative Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: J. Peter Rubin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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