Fat Grafting With Expanded Adipose-Derived Stromal Cells for Breast Augmentation: A Randomized Controlled Trial.

The trial used a randomized, double-blind design to compare ASC-enriched and placebo-enriched fat grafting. Participants underwent liposuction to collect fat for cell culture and grafting. ASCs were expanded in the laboratory and then added to the fat graft at a concentration of 10 × 10^6 cells per milliliter. Each participant received one breast treated with ASC-enriched fat and the other with placebo-enriched fat of the same volume. Randomization ensured that neither the participants nor the evaluators knew which breast received which treatment. MRI scans were used to measure fat graft volume at baseline and after 12 months. The primary outcome was the percentage of volume retained in each breast after one year. The study enrolled 10 participants, all of whom completed the trial and follow-up. The trial was registered with the European Union Drug Regulating Agency Clinical Trials Register (EudraCT-2014-000510-59).

After one year, the volume retention rate was 54.0% (95% CI, 30.4%-77.6%) in the ASC-enriched fat grafts. The placebo-enriched fat grafts showed a retention rate of 55.9% (95% CI, 28.9%-82.9%). The difference between the two groups was not statistically significant (P = 0.566). These results suggest that ASCs did not improve volume retention compared to standard fat grafting. No serious adverse events were reported during the trial. The sample size was small, with only 10 participants, which may limit the study's power to detect a true effect. The use of MRI allowed for accurate and objective measurement of fat volume over time. The study found no evidence that ASCs provide a measurable benefit in breast augmentation with lipofilling. The confidence intervals for both groups were wide, indicating some uncertainty in the results.

The trial found no evidence that ASC-enriched fat grafting improves volume retention in breast augmentation compared to standard fat grafting. The authors concluded that their findings do not support the use of ASCs in this context. The results suggest that the addition of ASCs does not provide a statistically significant advantage over placebo. The authors acknowledge the limitations of the study, including the small sample size. They propose that larger trials may be needed to confirm these findings. The authors emphasize the importance of using MRI for accurate volume measurements. No prior work had resolved whether ASCs offer a measurable benefit in this setting. The authors suggest that further research is needed to explore alternative methods for improving fat graft retention.