Stemcell treatment of drymouth after radiation therapy of HPV induced cancer in the tonsils or base of tongue

Mesenchymal stem cells for radiation-induced xerostomia (MESRIX) in previous HPV-positive oropharyngeal head and neck cancer patients - MESRIX

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004349-29-DK

Enrollment

Unknown

Registered

2015-02-04

Start date

2015-04-01

Completion date

Unknown

Last updated

2017-06-05

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

Conditions

The study will include participants with xerostomi (International Classification of Diseases-10: DQ 838A) and oropharyngeal cancer (DC 10). MedDRA version: 17.1 Level: LLT Classification code 10031103 Term: Oropharyngeal cancer stage unspecified System Organ Class: 100000004864 MedDRA version: 17.1 Level: LLT Classification code 10048223 Term: Xerostomia System Organ Class: 100000004856

Interventions

Product Name: Autologous adipose-derived stem cells / Mesenchymale stem cells (MSC) Pharmaceutical Form: INN or Proposed INN: EXPANDED HUMAN AUTOLOGOUS MESENCHYMAL ADULT STEM CELLS EXTRACTED FROM ADI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Previous radiotherapy for HPV-positive oropharyngeal head and neck cancer with bilateral irradiation of the neck. • 2 years follow-up without recurrence • Clinically reduced hyposalivation and hyposalivation, evaluated by a screening o Unstimulated salivary flow rate between less than 0.2ml/min and above 0.05ml/min • Only participants with previous T1-T2 and N0, N1 or N2a. • Informed consent • Grade 1-43 xerostomia as evaluated by the 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Any cancer in the previous 2 years • Xerogenic medications • Any previous other diseases in of the salivary glands, e.g. Sjögrens syndrome, sialolithiasis, etc. • Pregnancy or planned pregnancy within the next 2 years • Breastfeeding • Any other disease/condition judged by the investigator to be grounds for exclusion • Treatment with anticoagulant that cannot be stopped during the intervention period.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective is to examine whether enrichment of the submandibular gland with injection of autologous ASC will improve the result of salivary function in radiation-induced gland hypofunction. ;Secondary Objective: Screening of radiological and histological changes in the gland after stem cell-enriched fat injection as based on MRI and biopsy.;Primary end point(s): • Safety All measures of adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) [26]. Since this is a local treatment with MSCs the primary safety measures are: • Pain at injection site (Grade 1: Mild pain, grade 2: Moderate pain; limiting instrumental activities of daily living (ADL), grade 3: Severe pain; limiting self care ADL) • Oral discomfort (Grade 1: Mild discomfort; not interfering with oral intake, grade 2: Moderate pain; interfering with oral intake, 3: Disabling pain; tube feeding or TPN indicated) • Infection (Grade 1: Localized; local intervention indicated, grade 2: Oral intervention indicated (antibiotic, antifungal, antiviral), grade 3: IV antibiotic, antifungal or antiviral indicated; or radiologic, endoscopic or operative intervention indicated, grade 4: life threatening consequences; urgent intervention needed) ;Timepoint(s) of evaluation of this end point: 3-4 weeks and 3-4 months after intervention.	—

Measure

Time frame

Main Objective: The objective is to examine whether enrichment of the submandibular gland with injection of autologous ASC will improve the result of salivary function in radiation-induced gland hypofunction. ;Secondary Objective: Screening of radiological and histological changes in the gland after stem cell-enriched fat injection as based on MRI and biopsy.;Primary end point(s): • Safety All measures of adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) [26]. Since this is a local treatment with MSCs the primary safety measures are: • Pain at injection site (Grade 1: Mild pain, grade 2: Moderate pain; limiting instrumental activities of daily living (ADL), grade 3: Severe pain; limiting self care ADL) • Oral discomfort (Grade 1: Mild discomfort; not interfering with oral intake, grade 2: Moderate pain; interfering with oral intake, 3: Disabling pain; tube feeding or TPN indicated) • Infection (Grade 1: Localized; local intervention indicated, grade 2: Oral intervention indicated (antibiotic, antifungal, antiviral), grade 3: IV antibiotic, antifungal or antiviral indicated; or radiologic, endoscopic or operative intervention indicated, grade 4: life threatening consequences; urgent intervention needed) ;Timepoint(s) of evaluation of this end point: 3-4 weeks and 3-4 months after intervention.

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Secondary

Measure	Time frame
Secondary end point(s): • Significant increase in unstimulated and stimulated whole saliva flow rate in the group receiving MSCs, compared with the group of participants receiving placebo (control group). Salivary flow rate will be calculated as a change in the participant's saliva flow rate from before intervention (baseline) to four months after. • Significant decrease in complaints of xerostomia in the group receiving MSCs compared with the group of participants receiving placebo as evaluated by a physician and patient questionnaire. • Measurement of 4-months volume change of submandibular glands based on magnetic resonance imaging (MRI). Calculated as a change after 4 months compared to MRI before intervention (baseline). Registration of all unexpected side effects of the intervention. • Estimation of change in the amount of fibrosis from the MRI-scan between intervention and placebo group. • Estimation of the change in the amount of serous and mucinous gland tissue in histological sections from the biopsies taken pre- (baseline) and post-interventional. • Estimation in the change in fibrosis in histological sections from the biopsies taken pre- (baseline) and post-interventional. • Estimation in the change in vascularisation in histological sections from the biopsies taken pre- (baseline) and post-interventional. ;Timepoint(s) of evaluation of this end point: Biopsy and MRI: 3-4 weeks and 3-4 months after intervention.	—

Measure

Time frame

Secondary end point(s): • Significant increase in unstimulated and stimulated whole saliva flow rate in the group receiving MSCs, compared with the group of participants receiving placebo (control group). Salivary flow rate will be calculated as a change in the participant's saliva flow rate from before intervention (baseline) to four months after. • Significant decrease in complaints of xerostomia in the group receiving MSCs compared with the group of participants receiving placebo as evaluated by a physician and patient questionnaire. • Measurement of 4-months volume change of submandibular glands based on magnetic resonance imaging (MRI). Calculated as a change after 4 months compared to MRI before intervention (baseline). Registration of all unexpected side effects of the intervention. • Estimation of change in the amount of fibrosis from the MRI-scan between intervention and placebo group. • Estimation of the change in the amount of serous and mucinous gland tissue in histological sections from the biopsies taken pre- (baseline) and post-interventional. • Estimation in the change in fibrosis in histological sections from the biopsies taken pre- (baseline) and post-interventional. • Estimation in the change in vascularisation in histological sections from the biopsies taken pre- (baseline) and post-interventional. ;Timepoint(s) of evaluation of this end point: Biopsy and MRI: 3-4 weeks and 3-4 months after intervention.

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Countries

Denmark

Contacts

Public ContactRigshospitalet

Dept. of Otolaryngology, Head and Neck surgery

christian.von.buchwald@regionh.dk004535452071

Outcome results

None listed

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