Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2020-09-30

Brief Summary

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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.

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Detailed Description

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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

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Lymphedema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

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

Group Type EXPERIMENTAL

Cell-assisted lipotransfer

Intervention Type PROCEDURE

Stromal vascular fraction, autologous. Isolated using Celution System (Cytori)

Interventions

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Cell-assisted lipotransfer

Stromal vascular fraction, autologous. Isolated using Celution System (Cytori)

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No