Breast Cancer Clinical Trial
Official title:
Treatment of Benign Breast Deformities and Post-Segmental Mastectomy Breast Deformities With Autologous Fat Grafting (AFT)
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UPMC Center for Innovation in Restorative Medicine | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
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Dudas JR, Losee JE, Penascino VM, Smith DM, Cooper GM, Mooney MP, Jiang S, Rubin JP, Marra KG. Leporine-derived adipose precursor cells exhibit in vitro osteogenic potential. J Craniofac Surg. 2008 Mar;19(2):360-8. doi: 10.1097/SCS.0b013e318163e17b. — View Citation
Ellenbogen R. Free autogenous pearl fat grafts in the face--a preliminary report of a rediscovered technique. Ann Plast Surg. 1986 Mar;16(3):179-94. — View Citation
Illouz YG. The fat cell "graft": a new technique to fill depressions. Plast Reconstr Surg. 1986 Jul;78(1):122-3. — View Citation
Marra KG, Defail AJ, Clavijo-Alvarez JA, Badylak SF, Taieb A, Schipper B, Bennett J, Rubin JP. FGF-2 enhances vascularization for adipose tissue engineering. Plast Reconstr Surg. 2008 Apr;121(4):1153-64. doi: 10.1097/01.prs.0000305517.93747.72. — View Citation
Matsudo PK, Toledo LS. Experience of injected fat grafting. Aesthetic Plast Surg. 1988 Feb;12(1):35-8. — View Citation
Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-53. doi: 10.1097/PRS.0b013e3181aee807. — View Citation
Rigotti G, Marchi A, Galiè M, Baroni G, Benati D, Krampera M, Pasini A, Sbarbati A. Clinical treatment of radiotherapy tissue damage by lipoaspirate transplant: a healing process mediated by adipose-derived adult stem cells. Plast Reconstr Surg. 2007 Apr 15;119(5):1409-22; discussion 1423-4. — View Citation
Rigotti G, Marchi A, Stringhini P, Baroni G, Galiè M, Molino AM, Mercanti A, Micciolo R, Sbarbati A. Determining the oncological risk of autologous lipoaspirate grafting for post-mastectomy breast reconstruction. Aesthetic Plast Surg. 2010 Aug;34(4):475-80. doi: 10.1007/s00266-010-9481-2. Epub 2010 Mar 24. — View Citation
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
Sinna R, Delay E, Garson S, Delaporte T, Toussoun G. Breast fat grafting (lipomodelling) after extended latissimus dorsi flap breast reconstruction: a preliminary report of 200 consecutive cases. J Plast Reconstr Aesthet Surg. 2010 Nov;63(11):1769-77. doi: 10.1016/j.bjps.2009.12.002. Epub 2010 Jan 15. — View Citation
Spear SL, Wilson HB, Lockwood MD. Fat injection to correct contour deformities in the reconstructed breast. Plast Reconstr Surg. 2005 Oct;116(5):1300-5. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 |
Sample collected at time of procedure | No |
Primary | 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. | Through 12 months following procedure | No |
Secondary | Patient Satisfaction | Measure patient satisfaction with use of quality of life questionnaires (SF-36 and BREAST-Q) before and after autologous fat grafting. | 6 months after procedure | No |
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