Overview

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.