No Clinical Efficacy of Adipose-Derived Regenerative Cells and Lipotransfer in Breast Cancer-Related Lymphedema: A Double-Blind Placebo-Controlled Phase II Trial.
Jørgensen MG., Jensen CH., Hermann AP., Andersen DC., Toyserkani NM., Sheikh SP.
Randomized Controlled Trial, published in Plast Reconstr Surg (2024) — summary generated from the PubMed abstract.
Several human studies show positive signals, while research methods and sample sizes continue to develop.
- Level A · Stronger Clinical Evidence
- Level B · Emerging clinical evidence with positive signals
- Level C · Early human research exploring benefits
- Level D · Scientific groundwork from lab and animal studies
- Emerging · Emerging topic under active research
This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.
- Study type
- Randomized Controlled Trial
- Journal
- Plast Reconstr Surg (2024)
- Country
- United States
- Reported sample size
- —
- Source database
- PubMed
- PMID
- 39591365
- DOI
- 10.1097/PRS.0000000000011343
- NCT
- NCT03776721
- Citations
- 4
Abstract (original English)
Background Breast cancer-related lymphedema (BCRL) is a debilitating sequela affecting up to 1 in 3 breast cancer survivors. Treatments are palliative and do not address the underlying lymphatic injury. Recent preclinical and nonrandomized studies have shown promising results using adipose-derived regenerative cells (ADRCs) and lipotransfer in alleviating BCRL through regeneration of lymphatic tissue. However, no randomized controlled trial has been performed in an attempt to eliminate a placebo effect. Methods This randomized, double-blind, placebo-controlled trial included patients with no-option, persistent disabling unilateral BCRL. Patients were randomly assigned in a 1:1 ratio to receive either autologous ADRCs (4.20×10 7 ± 1.75×10 7 cells) and 30-cc lipotransfer or placebo (saline) to the axilla. The primary outcome was a change in BCRL volume 1 year after treatment. Secondary outcomes included changes in quality of life, indocyanine green lymphangiography stage, bioimpedance, and safety. Results Eighty patients were included, of whom 39 were allocated to ADRCs and lipotransfer treatment and 41 to placebo treatment. Baseline characteristics were similar in the groups. One year after treatment, no objective improvements were observed in the treatment or placebo groups. In contrast, significant subjective improvements were noted for both the treatment and placebo groups. C
What this study does not prove
- • This study does not prove SVF is an approved treatment or a replacement for standard care.
Evidence level
Several human studies show positive signals, while research methods and sample sizes continue to develop.
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