Clinical trial · Interventional
Treatment of Breast Cancer Related Lymphedema With Cell-assisted Lipotransfer
- 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 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
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cell-assisted lipotransfer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Treatment of lymphedema with cell-assisted lipotransfer using autologous stromal vascular fraction
- interventionNames
- Procedure: Cell-assisted lipotransfer
Primary outcomes (1)
- measure
- Change in arm volume
- timeFrame
- Baseline, 1, 3, 6, 12 and 48 months
- description
- Assessed by clinical measurements
Secondary outcomes (9)
- measure
- Side effects of treatment
- timeFrame
- 1, 3, 6, 12 and 48 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDToyserkani NM, Jensen CH, Andersen DC, Sheikh SP, Sorensen JA. Treatment of Breast Cancer-Related Lymphedema with Adipose-Derived Regenerative Cells and Fat Grafts: A Feasibility and Safety Study. Stem Cells Transl Med. 2017 Aug;6(8):1666-1672. doi: 10.1002/sctm.17-0037. Epub 2017 Jun 27. PMID 28653440
- DERIVEDToyserkani NM, Jensen CH, Sheikh SP, Sorensen JA. Cell-Assisted Lipotransfer Using Autologous Adipose-Derived Stromal Cells for Alleviation of Breast Cancer-Related Lymphedema. Stem Cells Transl Med. 2016 Jul;5(7):857-9. doi: 10.5966/sctm.2015-0357. Epub 2016 May 5. PMID 27151914