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

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

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.

Inclusion Criteria:

• Unilateral arm lymphedema secondary to breast cancer treatment including lymph node dissection.
• Cancer free for at least 1 year
• The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.
• The opposite upper extremity is healthy (no lymphedema).
• ASA score of 1 or 2.
• The patient is able to read, understand, and complete Danish questionnaires.
• Pitting lymphedema ISL grade 1 or 2.
• A minimum circumference difference of 2cm or a minimum volume difference of 200mL.

Exclusion Criteria:

• Pregnant or lactating.
• Bilateral lymphedema
• Current or previous malignancies other than breast cancer.
• Insulin-dependent diabetes.
• Diagnosed with any form of psychotic disorder, which may impact study participation.
• Not ceased smoking during treatment.
• Active implantables (e.g. pacemaker or neurostimulator)
• Unrealistic treatment expectations.
• Known hepatitis, HIV or syphilis infection.