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Pilot Study for Stem Cell Treatment of Breast cancer-related Lymphedema

Review of “Treatment of Breast Cancer-Related Lymphedema with Adipose-Derived Regenerative Cells and Fat Grafts: A Feasibility and Safety Study” from STEM CELLS Translational Medicine by Stuart P. Atkinson

Breast cancer-related lymphedema (BCRL) represents a common side effect for patients undergoing breast cancer treatment [1], manifesting as lymphatic fluid accumulation and subcutaneous tissue swelling in the arm caused by obstruction and/or destruction of lymphatic vessels. Unfortunately, common lifelong treatment strategies [2] are time-consuming and do not address the underlying problem [3].

Regenerative strategies employing the stem/progenitor cell-rich stromal vascular fraction of adipose tissue (or adipose-derived regenerative cells [ADRCs]) have described how cell transplantation can improve vascularity [4, 5] and, therefore, may represent a more efficient treatment option for BCRL patients. 

Researchers from the laboratory of Jens Ahm Sørensen (Odense University Hospital, Odense, Denmark) recently described a successful case study of ADRC transplantation in combination with fat grafting to alleviate lymphedema in one patient [18]. In STEM CELLS Translational Medicine, the team now return with an expanded pilot study to test the efficacy, safety, and feasibility of this ADRC-mediated regenerative strategy [6].

Let’s take a look at the first human pilot study design and its results:

  • Open–label, single-arm, single-center feasibility and safety study
    • 10 BCRL patients enrolled with 6 months follow-up
    • ADRCs collected via liposuction and injected directly into the axillary region 2 hours later (combined with a scar-releasing fat graft procedure)
  • Results generated during the 6-month follow-up period indicted a small non-significant volume reduction in the arm, although patient-reported outcomes improved significantly over time and five patients reduced their use of conservative management
    • Adverse events noted related to liposuction and fat grafting and not to ADRC transplantation
    • No cancer recurrence during follow-up period

Overall, these initial results demonstrate the safety of this approach and provide evidence that ADRC transplantation can alleviate symptoms of BCRL. The authors hope that their findings will prove sufficient to start a properly blinded randomized controlled trial with a follow-up of several years to ensure long-term safety. 

To keep up to date with this regenerative approach for BCRL, stay tuned to the Stem Cells Portal.


  1. DiSipio T, Rye S, Newman B, et al. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol 2013;14:500-515.
  2. International Society of L. The diagnosis and treatment of peripheral lymphedema: 2013 Consensus Document of the International Society of Lymphology. Lymphology 2013;46:1-11.
  3. Lasinski BB, McKillip Thrift K, Squire D, et al. A systematic review of the evidence for complete decongestive therapy in the treatment of lymphedema from 2004 to 2011. PM & R : the journal of injury, function, and rehabilitation 2012;4:580-601.
  4. Premaratne GU, Ma LP, Fujita M, et al. Stromal vascular fraction transplantation as an alternative therapy for ischemic heart failure: anti-inflammatory role. J Cardiothorac Surg 2011;6:43.
  5. Harada Y, Yamamoto Y, Tsujimoto S, et al. Transplantation of freshly isolated adipose tissue-derived regenerative cells enhances angiogenesis in a murine model of hind limb ischemia. Biomedical research 2013;34:23-29.
  6. Toyserkani NM, Jensen CH, Andersen DC, et al. Treatment of Breast Cancer-Related Lymphedema with Adipose-Derived Regenerative Cells and Fat Grafts: A Feasibility and Safety Study. STEM CELLS Translational Medicine 2017;6:1666-1672.