Short summary

Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Currently, lymphedema is primarily addressed conservatively. Emerging evidence suggest that regenerative medicine may provide a new treatment option for lymphedema by patching the underlying lymphatic dysfunction.

Rationale

Regenerative medicine provides a new treatment option for lymphedema. Stem cells have the potential to alleviate lymphedema and preclinical and clinical studies have so far shown promising potential. We conducted our own pilot study in 2016, which demonstrated that the treatment were safe, tolerable and with promising treatment effect. However, these promising results need to be confirmed in a larger, randomized and blinded trial.

This Phase 3 trial is a randomized and double-blinded placebo controllet trial. This study will examine the efficacy, effectiveness and safety of freshly isolated adipose-derived regenerative cells administered in conjunction with a fat grafting procedure to the affected axillary region. 

Patientes are seen preoperatively and 3, 6, 9 and 12 months postoperatively.

Description of the cohort

Patients with unilateral arm lymphedema following breast cancer treatment with axillary dissection and without signs of recurrence.

Data and biological material

We collect demographic and lymphedema-specific outcome data, clinical assessments of lymphedema, bioimpedance L-DEX score, DEXA scan, indocyanine-green lymphangiography, subjective questionnaires.

Collaborating researchers and departments

Department of Plastic and Reconstructive Surgery, Odense University Hospital 

• Mads Gustaf Jørgensen
• Jens Ahm Sørensen

Department of Clinical Biochemistry and Pharmacology, Odense University Hospital

• Charlotte Harken Jensen
• Søren Paludan Sheikh

Department of Endocrinology, Odense University Hospital 

• Anette Riis Madsen
• Steffanie Christensen
• Pernille Hermann

Publications associated with the project

Jørgensen MG, Toyserkani NM, Hansen FCG, Thomsen JB, Sørensen JA. Prospective Validation of Indocyanine Green Lymphangiography Staging of Breast Cancer-Related Lymphedema. Cancers (Basel). 2021 Mar 26;13(7):1540. doi: 10.3390/cancers13071540. PMID: 33810570; PMCID: PMC8063087.