NCT02592213

Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Lymphedema

Interventions

Type	Name	Description
PROCEDURE	Cell-assisted lipotransfer	Stromal vascular fraction, autologous. Isolated using Celution System (Cytori)

Timeline

• Start date: 2015-10-01
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2015-10-30
• Last updated: 2020-06-01

Locations

1 site across 1 country: Denmark