Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting

Summary

Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Currently, lymphedema is primarily addressed conservatively with compression garments. Regenerative medicine may provide a new treatment option for lymphedema. This Phase 3 trial will examine the efficacy, effectiveness and safety of freshly isolated adipose-derived stromal cells administered in conjunction with a fat grafting procedure to the affected axillary region.

Timeline

Start

2018-12-18

Primary completion

2021-06-01

Completion

2021-06-01

Publications

• Jorgensen MG, Jensen CH, Hermann AP, Andersen DC, Toyserkani NM, Sheikh SP, Sorensen JA. No Clinical Efficacy of Adipose-Derived Regenerative Cells and Lipotransfer in Breast Cancer-Related Lymphedema: A Double-Blind Placebo-Controlled Phase II Trial. Plast Reconstr Surg. 2024 Dec 1;154(6):1172-1182. doi: 10.1097/PRS.0000000000011343. Epub 2024 Feb 7.

Drugs

Indications