Repeated Mesenchymal Stem Cell Therapy for Radiation-Induced Hyposalivation and Xerostomia in Head and Neck Cancer Survivors

NCT07290946 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2025-522559-25-00
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Dry mouth leads to debilitating symptoms 24/7. The two primary causes for dry mouth are Sjögrens disease and after radiotherapy of a head and neck cancer. Former clinical trials have investigated mesenchymal stem cell treatment for dry mouth with promising results. However, few of the participants evolved normal salivary flow rate. Therefore, in this randomized clinical trial, two treatments of mesenchymal stem cells are administered, 4 months apart. This has not been done before. The hypothesis is that two treatments of mesenchymal stem cells results in a higher salivary flow rate and ameliorate symptoms from dry mouth.

Conditions

Xerostomia Due to Radiotherapy; Sjögren´s Syndrome; Xerostomia Due to Hyposecretion of Salivary Gland

Keywords

Mesenchymal Stem Cell; Sjögren; Radiation; xerostomia; Head and Neck cancer

Outcome Measures

Primary Outcomes (1)

• Unstimulated whole salivary flow rate

  Unstimulated whole salivary flow rate measured in mL/min

  T=0 months, T=4 months and T=8 months (primary endpoint assessed after 8 months)

Secondary Outcomes (5)

• Stimulated whole salivary flow rate

  T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).

• Patient-Reported Outcome of xerostomia: The Groningen Radiotherapy-Induced Xerostomia questionnaire (GRIX).

  T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).

• Patient-Reported Outcome of xerostomia: The European organization for research and treatment of cancer quality of life questionnaire, head and neck-35 (EORTC QLQ-H&N35).

  T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).

• Immune response

  T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).

• Patient Reported Outcome: Goal Attainment Scale (GAS)

  T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).

Other Outcomes (3)

• Incidence of treatment-related adverse events and serious adverse events

  Continually assessed from inclusion (T=0 months) to last visit (T=24 months).

• Outcome 1 to 6 assessed at long term follow-up

  T=0 months, T=4 months, T=8 months, T=12 months, and T=24 months

• 5-point transition scale for determining the minimal important difference (evaluated at 8 months)

  T=4 months, T=8 months.

Study Arms (2)

Mesenchymal Stem Cells

EXPERIMENTAL

Treatment with intraglandular injections in both submandibular glands with allogeneic adipose derived mesenchymal stem cells

Drug: ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS

Placebo

PLACEBO COMPARATOR

Treatment with intraglandular injections in both submandibular glands sterile isotonic saline water

Drug: Placebo

Interventions

Placebo DRUG

Sterile isotonic saline water

Placebo

ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS DRUG

Suspended in 10% DMSO. Manufactured by OUH CELL BENCH in Odense, Denmark.

Mesenchymal Stem Cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Former radiotherapy for squamous cell carcinoma, or adenocarcinoma, of the nasal sinus, larynx, pharynx, and oral cavity
• WHO Performance status 0-1
• Presence of xerostomia daily
• UWS of 0.05 mL/min to 0.5 ml/min
• Age above 18
• Informed consent
• year follow-up of the cancers in 1. with no recurrence

You may not qualify if:

• Any malignant cancer diagnosis excluding head and neck cancers
• Penicillin or streptomycin allergy assessed by health personnel
• Any other previous or active disease of the salivary glands (e.g. Sjögren's Disease, sialolothiasis)
• Previous submandibular surgery or biopsy
• Pregnancy or planned pregnancy until 4 months after second treatment
• Breastfeeding
• Smoking within the last 6 months
• Alcohol abuse within the last 6 months (consumption must not be above 10 units/week (Danish National board health alcohol guidelines)

Sponsors & Collaborators

• Christian von Buchwald: lead

MeSH Terms

Conditions

Sjogren's Syndrome; Xerostomia; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Neoplasms by Site; Neoplasms

Study Officials

• Christian von Buchwald, MD, Professor

  Copenhagen University Hospital - Rigshospital

  STUDY CHAIR

Central Study Contacts

Joachim Hansen, M.D

CONTACT

+4523312552; joachim.hansen.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: One research assistant preparing the treatments are unmasked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, DMSc, professor

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 18, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share