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.

Phase 1

Active, not recruiting

Conditions: The trial will include participants with Xerostomia ( International Classification of Diseases-10: DQ 838A)
MedDRA version: 20.0Level: LLTClassification code 10048223Term: XerostomiaSystem Organ Class: 100000004856
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Registration Number: EUCTR2018-003856-19-DK

Lead Sponsor: Department of Otorhinolaryngology, Head and Neck Surgery and Audiology. Rigshospitalet, University Hospital of Cph, DK

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 10

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 < 0.2 ml/min and above 0.05 ml/min
Grade 1-3 Xerostomia evaluated by UKU side effect rating scale
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>Change in unstimulated salivary flow rate;Timepoint(s) of evaluation of this end point: After 1 day, one month and four months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change in quality of life<br>Change in salivary gland function<br>Immune reponse to allogeneic ASC<br>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<br>Salivary flow rates after one month and 4 months<br>Quality of life questionnaires after 4 months<br>