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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Stromal vascular fraction, autologous. Isolated using Celution System (Cytori)
Odense University Hospital
Odense, Denmark
Change in arm volume
Assessed by clinical measurements
Time frame: Baseline, 1, 3, 6, 12 and 48 months
Side effects of treatment
Any side effects of experimental treatment. Assessed by asking the patient at each visit. All reported findings will be reported at study completion
Time frame: 1, 3, 6, 12 and 48 months
Subjective change assessed LYMQOL questionnaire
Subjective change of lymphedema assessed by questionnaire
Time frame: Baseline, 1, 3, 6, 12 and 48 months
Subjective change assessed DASH questionnaire
Subjective change of lymphedema assessed by questionnaire
Time frame: Baseline, 1, 3, 6, 12 and 48 months
Change in lymph drainage
Change in lymph drainage assessed by lymphoscintigraphy compared with preoperative lymphoscintigraphy
Time frame: Baseline and 12 months
Subjective change in feeling of tension in arm assessed by numeric scale from 0-10
Feeling of tension in the arm (separately) 0=healthy and 10=worst imaginable
Time frame: Baseline, 1, 3, 6, 12 and 48 months
Subjective change in feeling of heaviness in arm assessed by numeric scale from 0-10
Feeling of heaviness in the arm (separately) 0=healthy and 10=worst imaginable
Time frame: Baseline, 1, 3, 6, 12 and 48 months
Change in arm volume
Assessed by DXA scan
Time frame: Baseline, 3, 6 and 12 months
Number of arm infections
Number of arm infections needing antibiotic treatment. Assesed by asking the patient each visit.
Time frame: Baseline, 1, 3, 6, 12 and 48 months
Change in conservative lymphedema treatment
Change in use or type of conservative lymphedema treatments. Assesed by asking the patient each visit.
Time frame: Baseline, 1, 3, 6, 12 and 48 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.