A clinical study evaluating the safety of fat-tissue-derived stem cells from healthy donors as a treatment for dry mouth syndrome after radiotherapy of cancer in the tonsils or base of the tongue.

A Phase I Open Label Study Evaluating the Safety and Feasibility of Allogeneic Mesenchymal stem cells for radiation-induced hyposalivation and xerostomia in previous oropharyngeal patients

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003856-19-DK

Enrollment

Registered

2018-10-29

Start date

2019-01-09

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

The trial will include participants with Xerostomia ( International Classification of Diseases-10: DQ 838A) MedDRA version: 20.0 Level: LLT Classification code 10048223 Term: Xerostomia System Organ Class: 100000004856

Interventions

Product Name: Allgeneic adipose tissue-derived stromal/stem cells Product Code: CSCC_ASC(50) Pharmaceutical Form: Solution for injection INN or Proposed INN: Expanded human allogeneic mesenchymal adul

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Informed consent Previous radiotherapy for oropharyngeal OPSCC cancer stage I-II 2 years of follow-up without recurrence Clinically hyposalivation:unstimalted salivary flow =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: Any cancer in the previous 2 years ( not including basocellular carcinoma and OPSCC) Smoking Xerogenic medications Any current or previous otjer diseases in the salivary glands ( e.g Sjögrens syndrome, Sialolithiasis) Pregancy or planned pregnancy within the next 2 years Breastfeeding Any other disease/condition juged by the investigator to be grounds for exclusion

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective is to examine if injection of allogeneic mesenchymal stem cells into the parotid amd submandibular gland is safe and will improve the salivary gland function after radiation-induced damage;Secondary Objective: Changes in saliva production, changes in quality of life and monitorering immune response to allogeneic stem cell treatment;Primary end point(s): Safety Change in unstimulated salivary flow rate;Timepoint(s) of evaluation of this end point: After 1 day, one month and four months	—

Measure

Time frame

Main Objective: The objective is to examine if injection of allogeneic mesenchymal stem cells into the parotid amd submandibular gland is safe and will improve the salivary gland function after radiation-induced damage;Secondary Objective: Changes in saliva production, changes in quality of life and monitorering immune response to allogeneic stem cell treatment;Primary end point(s): Safety Change in unstimulated salivary flow rate;Timepoint(s) of evaluation of this end point: After 1 day, one month and four months

—

Secondary

Measure	Time frame
Secondary end point(s): Change in quality of life Change in salivary gland function Immune reponse to allogeneic ASC Change in composition of saliva;Timepoint(s) of evaluation of this end point: Safety and blood samples after 1 day, one month and 4 months Salivary flow rates after one month and 4 months Quality of life questionnaires after 4 months	—

Countries

Denmark

Contacts

Public ContactCharlotte Lynggaard

Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet, Denmark

clyn0015@regionh.dk+4535452370

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026