LAUSR

Breast cancer‐related lymphedema (BCRL) is a debilitating late complication with a lack of treatment opportunities. Recent studies have suggested that mesenchymal stromal cells can alleviate lymphedema. Herein, we report the results from the first human pilot study with freshly isolated adipose‐derived regenerative cells (ADRC) for treating lymphedema with 6 months follow‐up. Ten BCRL patients were included. ADRC was injected directly into the axillary region, which was combined with a scar‐releasing fat graft procedure. Primary endpoints were change in arm volume. Secondary endpoints were change in patient reported outcome and safety. The study is registered with ClinicalTrials.gov (NCT02592213). During follow‐up, a small volume reduction was noted but was not significant. Five patients reduced their use of conservative management. Patient‐reported outcomes improved significantly over time. ADRCs were well tolerated and only minor transient adverse events related to liposuction were noted. In this pilot study, a single injection of ADRC improved lymphedema based on patient‐reported outcome measures, and there were no serious adverse events in the 6 months follow‐up period. In addition, half of the patients reduced their use of conservative management. ADRC therapy is a promising interventional therapy for alleviating lymphedema, but results need to be confirmed in randomized clinical trials. Stem Cells Translational Medicine 2017;6:1666–1672