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Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer

NCT02592213 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-06-01

No results posted yet for this study

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.

Conditions

  • Lymphedema

Interventions

PROCEDURE

Cell-assisted lipotransfer

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

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Navid M Toyserkani, MD · Dept. Plastic and Reconstructive Surgery, Odense University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02592213 on ClinicalTrials.gov