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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522559-25-00

Enrollment

100

Registered

2025-09-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Xerostomia due to readiotherapy for a head & neck cancer

Brief summary

The primary outcome measure will be unstimulated whole salivary flow rate (measured by sialometry) from baseline (t=0) to 8 months, assessed at baseline, 4, and 8 months. This domain has been chosen as whole salivary flow rate is observed to be the cardinal symptom in xerostomia[34]. The primary endpoint will be assessed as the difference between groups measured after 8 months in mL/min.

Interventions

DRUGCulture expanded Adipose Derived Regenerative Cells

DRUGADRC001

DRUGSterile Isotone Saline Water

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary outcome measure will be unstimulated whole salivary flow rate (measured by sialometry) from baseline (t=0) to 8 months, assessed at baseline, 4, and 8 months. This domain has been chosen as whole salivary flow rate is observed to be the cardinal symptom in xerostomia[34]. The primary endpoint will be assessed as the difference between groups measured after 8 months in mL/min.	—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026