Objectives: Our clinical results of multiple cell-assisted lipotransfer (CAL) sessions (Step-CAL) to reconstruct postmastectomy breasts have been reported, but patients with insufficient fat are ineligible for this method. Therefore, this study was conducted to examine the safety and efficacy of breast reconstruction through Step-CAL using cultivated autologous adipose-derived stromal/stem cells (ASCs) to reduce the required fat mass.
Methods: This single-arm, open-label, clinical study was performed involving five patients after mastectomy for breast cancer. After tissue expander insertion, the breast was reconstructed by CAL repeated for three sessions using cultured ASCs at 4-6-month intervals. Final observations were made at 6 months after the third CAL procedure. During the treatment course, all adverse events were recorded to evaluate safety, and the reconstructed breast volume was measured by three-dimensional image analysis and compared with the contralateral healthy breast to evaluate the volume recovery rate and cosmetic results.
Results: For all five patients, no laboratory test abnormalities or adverse events attributed to treatment were observed between treatment initiation and the final observation. The amount of fat required for treatment was significantly reduced by culturing ASCs, and the operative time was shortened. The esthetic results regarding the reconstructed breasts were generally good, although differences with the contralateral breast remained in some cases.
Conclusions: These results suggest that Step-CAL using cultivated autologous ASCs is a safe treatment, reduces the burden on patients, and is useful as a method for breast reconstruction.
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