Mesenchymal Stemcells for Radiation Induced Xerostomia

• Status: Completed
• Trial end date: 2017-04-06
• Target enrollment: 0
• Participant gender: All

Summary

The current study aims to assess the safety and feasibility of the injection of autologous adipost tissue derived MSCs on radiation-induced salivary gland hypofunction and xerostomia in head and neck cancer participants. The project can potentially help to develop a clinically relevant treatment option for the growing number of patients suffering from xerostomia after radiotherapy. The development of new therapies is especially important, since only sub-optimal symptomatic treatments are currently available and the symptom of xerostomia greatly reduces the quality of life.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rigshospitalet, Denmark

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 salivation and hyposalivation, evaluated by a screening

• 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 1-3 xerostomia as evaluated by the UKU side effect rating scale

Exclusion Criteria:

• Any cancer in the previous 2 years

• Xerogenic medications

• Any other diseases 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.