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| Title |
Autologous Mesenchymal Stem Cell Transplantation Improves Unstimulated Salivary Flow in Patients With Radiation-Induced Xerostomia |
| Clinical Question |
In patients with radiation-induced xerostomia, can Mesenchymal Stem Cell treatment increase saliva production and reduce xerostomia symptoms? |
| Clinical Bottom Line |
For patients with radiation-induced xerostomia, transplantation of autologous adipose-derived mesenchymal stem cells is more effective than placebo in improving unstimulated salivary flow. This is supported by a trial showing improvement in unstimulated salivary flow, some patient-reported xerostomia symptoms, and salivary gland function without treatment-related adverse events in patients who were selected based on their ability to produce an adequate number of stem cells. |
| Best Evidence |
(you may view more info by clicking on the PubMed ID link) |
| PubMed ID |
Author / Year |
Patient Group |
Study type
(level of evidence) |
| #1) 29678523 | Grønhøj/2018 | 30 patients, in a randomized 1:1 ratio | Randomized Controlled Trial | | Key results | In a randomized controlled trial, 30 patients with radiation-induced xerostomia following radiotherapy for HPV-positive oropharyngeal squamous cell carcinoma were assigned in a 1:1 ratio to receive either adipose tissue-derived mesenchymal stem cells (ASCs) or placebo through ultrasound-guided transplantation into the submandibular glands. The ASCs injected corresponded to a dose of 2.8 x 106 ASCs multiplied by the volume of each patient’s submandibular gland (cm3).
The primary outcome was a change in unstimulated whole salivary flow rate. Patients treated with ASCs experienced significant improvements in unstimulated salivary flow rates, with a 33% increase after 1 month (P=0.048) and a 50% increase after 4 months (P=.003). The placebo treatment showed no significant improvement (P=.6 and P=.8 respectively). Participants in the ASC group also reported fewer xerostomia symptoms, including less thirst (-22%; P=.035) and difficulty eating solid foods (-2%; P=.008) after 4 months.
Additionally, salivary gland biopsies and tissue staining analyses showed evidence of tissue regeneration in the ASC group compared with placebo, and no serious treatment-related adverse events were reported. Salivary gland secretory function also improved significantly, with 100% of ASC-treated patients demonstrating physiologically normal secretory function at 4 months compared with 80% of placebo patients (P<.001). Histologic analysis demonstrated significantly increased serous gland tissue (P=.038) and significantly decreased connective/adipose tissue (P=.02) in the ASC group compared with placebo, suggesting tissue regeneration.
This study shows evidence of ASC therapy being safe and effective in improving salivary gland functions and xerostomia symptoms. However, the study was limited by its small sample size, short follow-up period, and single-center study, making it difficult to apply the treatment to a broader patient group. In addition, the short follow-up period means it is unclear how lasting the effects of the treatment are. Since the treatment relies on autologous-derived stem cells, further research is needed to determine if patients can naturally produce high-quality stem cells, specifically cancer patients. | |
| Evidence Search |
(“xerostomia”) AND (“radiation”) AND (“mesenchymal stem cells”) AND (“salivary glands”) |
Comments on
The Evidence |
The randomized, placebo-controlled design as well as the blinding of patients and investigators strengthen the reliability of the study and reduce the potential for bias. Both groups were assessed using the same methods and follow-up schedule. The outcomes included measurements of salivary flow as well as patient-reported symptoms. However, three patients assigned to the ASC group did not receive treatment because sufficient stem cell expansion could not be achieved in two patients and in one patient, the MRI evaluation couldn’t be completed. Therefore, they were not included in the final analysis, which may have introduced selection bias and limits external validity. Along with the excluded patients, the small sample size and variability in unstimulated salivary flow measurements also limit the precision and certainty of the results. Overall, the study design supports the validity of the findings, but these limitations should be considered when interpreting the results.
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| Applicability |
Mesenchymal stem cell therapy demonstrated improved salivary gland function and xerostomia symptoms without treatment-related adverse events. This study’s findings suggest that autologous adipose-derived MSC transplantation may be a promising treatment option for radiation-induced xerostomia. However, the treatment requires adipose tissue harvesting, laboratory expansion of stem cells, and ultrasound-guided transplantation into the salivary gland. Additionally, some patients are unable to produce sufficient stem cells for transplantation. Further, clinical trials with larger patient populations and longer follow-up periods are needed to confirm the safety and efficacy of this treatment and support broader clinical application. |
| Specialty/Discipline |
(Oral Medicine/Pathology/Radiology) (General Dentistry) |
| Keywords |
Xerostomia, salivary glands, adipose-derived mesenchymal stem cells, radiation-induced xerostomia, transplantation
|
| ID# |
3768 |
| Date of submission: |
07/27/2026 |
| E-mail |
msheevah@yahoo.com; devptx@gmail.com |
| Author |
Sheevah Monjazeb and Dev Patel |
| Co-author(s) |
Jerry Chen, Parveez Ahmad Abdul Azees, David D. Dean, Xiao-Dong Chen, and Chih-Ko Yeh |
| Co-author(s) e-mail |
chenj14@uthscsa.edu, abdulazees@uthscsa.edu, DeanD@uthscsa.edu |
| Faculty mentor/Co-author |
Dr. Xiao-Dong Chen and Dr. Chih-Ko Yeh |
| Faculty mentor/Co-author e-mail |
chenx4@uthscsa.edu and YEH@uthscsa.edu |
Basic Science Rationale
(Mechanisms that may account for and/or explain the clinical question, i.e. is the answer to the clinical question consistent with basic biological, physical and/or behavioral science principles, laws and research?) |
post a rationale |
| None available | |
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Comments and Evidence-Based Updates on the CAT
(FOR PRACTICING DENTISTS', FACULTY, RESIDENTS and/or STUDENTS COMMENTS ON PUBLISHED CATs) |
post a comment |
| None available | |
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