Long-term Effectiveness and Safety of Mesenchymal Stromal Cell Therapy for Radiation-Induced Hyposalivation in Head and Neck Cancer Survivors: A Randomized Phase II Trial.
Fenger Carlander AL., Jakobsen KK., Todsen T., Paaske N., Østergaard Madsen AK., Bendtsen SK.
Clinical Trial, published in Clin Cancer Res (2025) — 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
- Clinical Trial
- Journal
- Clin Cancer Res (2025)
- Country
- United States
- Reported sample size
- —
- Source database
- PubMed
- PMID
- 39751638
- DOI
- 10.1158/1078-0432.CCR-24-2663
- Citations
- 3
Abstract (original English)
Purpose The long-term effect of adipose-derived mesenchymal stromal cells (ASC) on restoring radiation-induced salivary gland hypofunction in patients with previous head and neck cancer has not been validated in larger settings. Patients and methods The study was a 12-month follow-up of a randomized trial, including patients with hyposalivation. Patients were randomized to receive allogeneic ASC or placebo in the submandibular glands. The primary endpoint was unstimulated whole saliva (UWS) followed by stimulated whole saliva, patient-reported outcomes (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, Head and Neck Module, and the xerostomia questionnaire), and safety. Results Of the 120 enrolled patients, 117 (97.5%) were assessed at 12 months. Treatment with ASC did not increase UWS compared with placebo: Increase in UWS was 0.02 mL/minute [95% confidence interval (CI), 0.01-0.04] in the ASC group and 0.02 mL/minute (95% CI, 0-0.03) in the placebo group (P = 0.56). ASC reduced the symptom burden for dry mouth with -10.07 units (95% CI, -13.39 to -6.75) compared with -4.15 units (95% CI, -7.46 to -0.84) in the placebo group (P = 0.01). Compared with placebo, ASC did not improve sticky saliva (-9.27 vs. -4.55 units; P = 0.13), swallowing (-4.50 vs. 3.49 units; P = 0.5), or xerostomia (-3.12 vs. -2.74 units; P = 0.82). Treatment was safe
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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