Clinical outcome is unlinked to injection of adipose-derived regenerative cells in the axilla of breast cancer-related lymphedema patients.
Andersen DC., Bjerre FA., Jørgensen MG., Sørensen JA., Jensen CH.
Randomized Controlled Trial with a reported sample of 10, published in Stem Cell Res Ther (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
- Stem Cell Res Ther (2024)
- Country
- England
- Reported sample size
- 10
- Source database
- PubMed
- PMID
- 39543743
- PMCID
- PMC11566835
- DOI
- 10.1186/s13287-024-04037-z
- NCT
- NCT03776721
- Citations
- 2
Abstract (original English)
Background Injection of autologous adipose-derived regenerative cells (ADRCs) combined with lipotransfer has been suggested to alleviate symptoms in diseases including breast cancer-related lymphedema (BCRL). We recently performed a randomized controlled trial injecting lipoaspirate with ADRCs into the axilla of BCRL patients, and here we aimed in the intervention group to define in an unbiased fashion whether ADRC injection was linked to the clinical outcome. Methods 39 BCRL patients received lipotransfer assisted with autologous ADRCs (4.20 × 10 7 ± 1.75 × 10 7 cells) whereas 41 BCRL patients were included for placebo treatment. At 12 month follow-up, we assessed quality of life, lymphangiography, and bioimpedance enclosing 59 outcome parameters. Multifactorial analysis of clinical outcomes was used to define responders and non-responders to the intervention, and collected ADRCs from these patient groups were analyzed by single cell RNA sequencing (scRNAseq). Results Unbiased multifactorial analysis ranked and defined the clinical outcomes (Sf36 physical change, L-Dex Lymph Change, ICG mdanderson change) with the highest effect on BCRL patients. The 10 patients with the highest- and lowest effect (five responders and five non-responders) were included in the study. No difference between non-responders and responders were observed for injected ADRC number/size/viability (p > 0
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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