Authors: Kitamura K, Kajitani K, Hedrick M, Sugimachi K. Kyushu Central Hospital, Fukuoka, Japan; Cytori Therapeutics, San Diego, CA
Summary:
Breast conservation therapy (BCT) for breast cancer (BRCA) typically results in breast asymmetry due to avascular fibrosis and atrophy of breast tissue. Currently, there are no clinically relevant techniques to reconstruct these defects. An investigator-initiated clinical study of a novel reconstructive technique utilizing the automated Celution System for rapid extraction and concentration of Adipose-Derived Stem Cells (ADSC) is presented.
Materials and Methods--All patients signed IRB-approved informed consents. Five female patients 12 or more months post BCT for BRCA and free of metastases or recurrence underwent six stem cell augmented reconstruction procedures. Standard tumescent liposuction was performed under general anesthesia. One half of the adipose tissue harvested was processed in the Celution device yielding a 5 cc suspension of ADSCs. The remaining fat was cleansed of blood, enriched with concentrated ADSCs, and injected during the same procedure under local anesthesia. Follow-up assessments were performed at 1 week and 3 and 6 months.
Results--Mean tumor size was 23 gm, cumulative dose of radiation therapy - 53 Gy. The stem cell augmented reconstruction procedure was performed on average of 27 months after BCT. The graft volume was patient-specific and ranged from 75 to 200 cc. The procedure was deemed safe in all patients. Tissue thickness measurements (TTM) were taken using 2-D ultrasound at 3 and 6 months post procedure at the most prominent area of the scar where ADSC treatment was performed. At 3 months post procedure, TTM showed increase in breast tissue thickness of +11 mm from baseline, and at 6 months remained +10 mm demonstrating durable treatment effect (p=NS for change from 3 to 6 months).
Conclusions--The stem cell augmented reconstruction procedure utilizing the Celution device for preparation of ADSC-enhanced autologous fat grafts was deemed safe, effective, and produced durable results in all patients treated. Larger, randomized studies are necessary to assess long-term safety and efficacy of this promising new option to addressing an important unmet medical need.
Source:
30th Annual San Antonio Breast Cancer Symposium, 12/13-16/07, Poster Session IV: Treatment: Breast Conservation (7:00 AM-9:00 AM).