Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer

Phase 1

Brief Summary: Breast cancer is the most common cancer type among women. Treatment in many cases involves axillary lymphadenectomy followed by radiation therapy. This increases the risk of lymphedema development which occurs in up to 30% of such cases. The present treatment paradigm is conservative with compression garments. There is a need for more effective treatment options and regenerative medicine offers hope for a change to a more curative approach. This Phase 2 trial will examine the efficacy and safety of treatment with freshly isolated adipose-derived stromal cells administered as a cell-assisted lipotransfer to the affected axillary region.

Detailed Description: Breast cancer is the most common cancer type among women. Treatment in many cases involves axillary lymphadenectomy followed by radiation therapy. This increases the risk of lymphedema development which occurs in up to 30% of such cases. The present treatment paradigm is conservative with compression garments. There is a need for more effective treatment options and regenerative medicine offers hope for a change to a more curative approach. This Phase 2 trial will examine the efficacy and safety of treatment with freshly isolated adipose-deried stromal cells administered as a cell-assisted lipotransfer to the affected axillary region.

Investigators plan to include 10 patients with unilateral lymphedema after previous breast cancer treatment

Recruitment & Eligibility

Inclusion Criteria

Unilateral arm lymphedema secondary to breast cancer treatment including lymph node dissection.
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.
ASA score of 1 or 2.
The patient is able to read, understand, and complete Danish questionnaires.
Lymphedema grade 1 or 2. A minimum circumference distance of 2cm on either lower or upper arm.

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Treatment	Cell-assisted lipotransfer	Treatment of lymphedema with cell-assisted lipotransfer using autologous stromal vascular fraction

Primary Outcome Measures

Name	Time	Method
Change in arm volume	Baseline, 1, 3, 6, 12 and 48 months	Assessed by clinical measurements

Secondary Outcome Measures

Name	Time	Method
Subjective change assessed DASH questionnaire	Baseline, 1, 3, 6, 12 and 48 months	Subjective change of lymphedema assessed by questionnaire
Change in conservative lymphedema treatment	Baseline, 1, 3, 6, 12 and 48 months	Change in use or type of conservative lymphedema treatments. Assesed by asking the patient each visit.
Side effects of treatment	1, 3, 6, 12 and 48 months	Any side effects of experimental treatment. Assessed by asking the patient at each visit. All reported findings will be reported at study completion
Subjective change in feeling of tension in arm assessed by numeric scale from 0-10	Baseline, 1, 3, 6, 12 and 48 months	Feeling of tension in the arm (separately) 0=healthy and 10=worst imaginable
Change in arm volume	Baseline, 3, 6 and 12 months	Assessed by DXA scan
Subjective change assessed LYMQOL questionnaire	Baseline, 1, 3, 6, 12 and 48 months	Subjective change of lymphedema assessed by questionnaire
Subjective change in feeling of heaviness in arm assessed by numeric scale from 0-10	Baseline, 1, 3, 6, 12 and 48 months	Feeling of heaviness in the arm (separately) 0=healthy and 10=worst imaginable
Number of arm infections	Baseline, 1, 3, 6, 12 and 48 months	Number of arm infections needing antibiotic treatment. Assesed by asking the patient each visit.
Change in lymph drainage	Baseline and 12 months	Change in lymph drainage assessed by lymphoscintigraphy compared with preoperative lymphoscintigraphy