Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting
NCT ID: NCT03776721
Last Updated: 2021-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2018-12-18
2021-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer
NCT02592213
Treatment of Postmastectomy Pain Syndrome With Fat Grafting
NCT03081286
Early Detection and Intervention for Mild and Moderate Lymphedema in Patients Treated for Breast Cancer
NCT00959985
Use of Stem Cells in Lymphedema Post Mastectomy
NCT01112189
Lymphaticovenous Anastomosis as Treatment for Lymphedema
NCT05441943
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Participants are blinded, care providers postoperatively are blinded, primary investigator is blinded and all outcome assessors are blinded. The surgeon performing the liposuction and the stem-cell staff are unblinded.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active treatment
Liposuction
Liposuction is performed on the abdomen or thighs.
Fat graft
30mL harvested lipoaspirate is injected at the affected axillary site.
Stem cell injection
4mL stem cell suspension injected at the affected axillary site.
Placebo treatment
Liposuction
Liposuction is performed on the abdomen or thighs.
Sham graf (Saline injection)
30mL saline is injected at the affected axillary site.
Saline injection
4mL saline injected at the affected axillary site.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Liposuction
Liposuction is performed on the abdomen or thighs.
Fat graft
30mL harvested lipoaspirate is injected at the affected axillary site.
Sham graf (Saline injection)
30mL saline is injected at the affected axillary site.
Stem cell injection
4mL stem cell suspension injected at the affected axillary site.
Saline injection
4mL saline injected at the affected axillary site.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Cancer free for at least 1 year
* The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.
* The opposite upper extremity is healthy (no lymphedema).
* ASA score of 1 or 2.
* The patient is able to read, understand, and complete Danish questionnaires.
* Pitting lymphedema ISL grade 1 or 2.
* A minimum circumference difference of 2cm or a minimum volume difference of 200mL.
Exclusion Criteria
* Bilateral lymphedema
* Current or previous malignancies other than breast cancer.
* Insulin-dependent diabetes.
* Diagnosed with any form of psychotic disorder, which may impact study participation.
* Not ceased smoking during treatment.
* Active implantables (e.g. pacemaker or neurostimulator)
* Unrealistic treatment expectations.
* Known hepatitis, HIV or syphilis infection.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Odense University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mads Gustaf Jørgensen
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jens A Sørensen, MD, PhD
Role: STUDY_CHAIR
Department of Plastic Surgery, Odense University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Plastic and Reconstructive Surgery
Odense, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Jorgensen MG, Jensen CH, Hermann AP, Andersen DC, Toyserkani NM, Sheikh SP, Sorensen JA. No Clinical Efficacy of Adipose-Derived Regenerative Cells and Lipotransfer in Breast Cancer-Related Lymphedema: A Double-Blind Placebo-Controlled Phase II Trial. Plast Reconstr Surg. 2024 Dec 1;154(6):1172-1182. doi: 10.1097/PRS.0000000000011343. Epub 2024 Feb 7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
S-20180117
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.