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Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting

NCT03776721 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-06-25

No results posted yet for this study

Summary

Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Currently, lymphedema is primarily addressed conservatively with compression garments. Regenerative medicine may provide a new treatment option for lymphedema. This Phase 3 trial will examine the efficacy, effectiveness and safety of freshly isolated adipose-derived stromal cells administered in conjunction with a fat grafting procedure to the affected axillary region.

Conditions

  • Lymphedema

Interventions

PROCEDURE

Liposuction

Liposuction is performed on the abdomen or thighs.

PROCEDURE

Fat graft

30mL harvested lipoaspirate is injected at the affected axillary site.

PROCEDURE

Sham graf (Saline injection)

30mL saline is injected at the affected axillary site.

BIOLOGICAL

Stem cell injection

4mL stem cell suspension injected at the affected axillary site.

PROCEDURE

Saline injection

4mL saline injected at the affected axillary site.

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Jens A Sørensen, MD, PhD · Department of Plastic Surgery, Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-18
Primary Completion
2021-06-01
Completion
2021-06-01

Countries

  • Denmark

Study Locations

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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 NCT03776721 on ClinicalTrials.gov