Clinical trial · Interventional
Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting
NCT03776721CI-TRIAL-00052446completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fat graft | Procedure | — | UNRESOLVED |
| Liposuction | Procedure | — | UNRESOLVED |
| Saline injection | Procedure | — | UNRESOLVED |
| Sham graf (Saline injection) | Procedure | — | UNRESOLVED |
| Stem cell injection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active treatment
- interventionNames
- Procedure: Liposuction
- Procedure: Fat graft
- Biological: Stem cell injection
- type
- PLACEBO_COMPARATOR
- label
- Placebo treatment
- interventionNames
- Procedure: Liposuction
- Procedure: Sham graf (Saline injection)
- Procedure: Saline injection
Primary outcomes (1)
- measure
- Change in arm volume
- timeFrame
- Baseline, 3, 6, 9 and 12 months
- description
- Assessed using clinical circumference measurement
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Unilateral arm lymphedema secondary to breast cancer treatment including lymph node dissection. * 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: * Pregnant or lactating. * 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.
References
Publications (1)
- DERIVEDJorgensen 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. PMID 39591365