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

Odense University Hospital

Status and phase

Completed

Phase 2

Conditions

Lymphedema

Treatments

Procedure: Sham graf (Saline injection)

Procedure: Liposuction

Biological: Stem cell injection

Procedure: Saline injection

Procedure: Fat graft

Study type

Interventional

Funder types

Other

Identifiers

NCT03776721

S-20180117

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.