Stem cell treatment of dry mouth after radiation therapy of head and neck cancer

Mesenchymal stem cells for radiation-induced hyposalivation and xerostomia in previous head and neck cancer patients (MESRIX-II) - MESRIX_III

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000348-24-DK

Enrollment

120

Registered

2018-03-27

Start date

2018-06-11

Completion date

Unknown

Last updated

2024-03-18

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) who have been treated with raditherapy for a head and neck cancer prevoiusly. MedDRA version: 20.1 Level: PT Classification code 10013781 Term: Dry mouth System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: LLT Classification code 10048223 Term: Xerostomia System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: HLT Classifica

Interventions

Product Name: Allogeneic adipose-derived mesenchymal stem cells/ aMSCs/ASCs Pharmaceutical Form: Living tissue equivalent INN or Proposed INN: EXPANDED HUMAN ALLOGENEIC MESENCHYMAL ADULT STEM CELLS EX

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Previous radiotherapy for head and neck cancer 2 years follow-up without recurrence Clinically hyposalivation: unstimulated salivary flow =65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Any cancer in the previous 2 years ( not including OPSCC and basocellular carcinoma) Smoking within the last 6 months Xerogenic medications within the last 3 months Any current or previous other diseases in the salivary glands (Sjögrens syndrome, Sialolithiasis etc.) Pregnancy or planned pregnancy with the next 2 years Breastfeeding Any other disease/condition juged by the investigator to be grounds for exclusion

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 4 months and 12 months after intervention;Main Objective: The objective is to examine whether enrichment of the submandibular glands with injections of allogeneic ASCs will improve the salivary function in radiation-induced salivary damage. ;Secondary Objective: Screening of changes in quality of life and immune response secondary to treatment with allogeneic adipose-derived mesenchymal stem cells. Further the objective is to investigate whether repeated treatment witj allogenic ASCs is better than a single treatment. ;Primary end point(s): Change in unstimulated salivary flow rate	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 4 months and 12 months after intervention;Main Objective: The objective is to examine whether enrichment of the submandibular glands with injections of allogeneic ASCs will improve the salivary function in radiation-induced salivary damage. ;Secondary Objective: Screening of changes in quality of life and immune response secondary to treatment with allogeneic adipose-derived mesenchymal stem cells. Further the objective is to investigate whether repeated treatment witj allogenic ASCs is better than a single treatment. ;Primary end point(s): Change in unstimulated salivary flow rate

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Secondary

Measure	Time frame
Secondary end point(s): 1. Safety 2. Change in quality of life. 3. Change in saliva flow rate assessed by sialometri 4. Immune response to allogeneic ASC. 5. Change in the composition of saliva 6. Change in salivary gland function at four months, 1 year and 2 years after repeated treatment, measured by an increase in unstimulated and stimulated whole SFR. 7. Change in quality of life after repeated treatment. Evaluated by a decrease in complaints of xerostomia as evaluated by two patient questionnaires (EORTC QLQ Module for H&N-35and XQ) at four months, 1 year and 2 years. 8. Change in the composition of saliva after four months, 1 year and 2 years after repeated treatment. ;Timepoint(s) of evaluation of this end point: Blood samples 4 and 12 months after intervention. For repeated treatment also after 24 months. Quality of life questionnaires after 4 and 12 months after intervention. For repeated treatment also after 24 months. Sialometri after 4 and 12 months after intervention. For repeated treatment also after 24 months.	—

Measure

Time frame

Secondary end point(s): 1. Safety 2. Change in quality of life. 3. Change in saliva flow rate assessed by sialometri 4. Immune response to allogeneic ASC. 5. Change in the composition of saliva 6. Change in salivary gland function at four months, 1 year and 2 years after repeated treatment, measured by an increase in unstimulated and stimulated whole SFR. 7. Change in quality of life after repeated treatment. Evaluated by a decrease in complaints of xerostomia as evaluated by two patient questionnaires (EORTC QLQ Module for H&N-35and XQ) at four months, 1 year and 2 years. 8. Change in the composition of saliva after four months, 1 year and 2 years after repeated treatment. ;Timepoint(s) of evaluation of this end point: Blood samples 4 and 12 months after intervention. For repeated treatment also after 24 months. Quality of life questionnaires after 4 and 12 months after intervention. For repeated treatment also after 24 months. Sialometri after 4 and 12 months after intervention. For repeated treatment also after 24 months.

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Countries

Denmark

Contacts

Public ContactChristian Von Buchwald

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

christian.von.buchwald@regionh.dk004535452370

Outcome results

None listed

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