Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer

Odense University Hospital

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Lymphedema

Treatments: Procedure: Cell-assisted lipotransfer

Study type: Interventional

Funder types: Other

Identifiers

NCT02592213

S-20150109

Details and patient eligibility

About

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.

Full 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

Enrollment: 10 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Unilateral arm lymphedema secondary to breast cancer treatment including lymph node dissection.
2. The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.
3. The opposite upper extremity is healthy.
4. ASA score of 1 or 2.
5. The patient is able to read, understand, and complete Danish questionnaires.
6. Lymphedema grade 1 or 2. A minimum circumference distance of 2cm on either lower or upper arm.

Exclusion criteria

1. The patient is pregnant or lactating.
2. The patient has bilateral lymphedema of the upper extremities.
3. The patient has or has had other malignancies other than breast cancer.
4. The patient is treated with anti-diabetic medication.
5. The patient is diagnosed with any form of psychotic disorder.
6. The patient is smoking.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment

Experimental group

Description:

Treatment of lymphedema with cell-assisted lipotransfer using autologous stromal vascular fraction

Treatment:

Procedure: Cell-assisted lipotransfer