Clinical trial · Interventional

Mesenchymal Stemcells for Radiation Induced Xerostomia

Mesenchymal Stem Cells for Radiation-induced Xerostomia (MESRIX) in Previous HPV-positive Oropharyngeal Head and Neck Cancer Patients - A Safety and Feasibility Study

NCT02513238CI-TRIAL-00062913MESRIXcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Xerostomia	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Isotonic NaCl	Drug	—	UNRESOLVED
Mesenchymal stem cell	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Stemcells injected into submandibularis
description
The surgical procedure is done under local anaesthesia using ultrasonic guidance and sterile technique. After receiving the MSC-suspension , the surgeon will identify the submandibular glands and inject the suspension MSCs into the submandibular gland. Calculation of injected number of MSCs pr. participant rests on the following calculation: 2.8 x 10\^6 MSC / Cm\^3 X volume , where volume is the volume of the submandibular gland, and a gland-volume of app. 7-8cm3 is the norm. Therefore the amount of cells given to each participant will be app. 4.6 x 10\^7 MSC in total. Afterwards the participant will be given a band-aid and over the counter analgesics.
interventionNames
1. Drug: Mesenchymal stem cell
type
PLACEBO_COMPARATOR
label
Saltwater injected into submandibularis
description
The surgical procedure is done under local anaesthesia using ultrasonic guidance and sterile technique. After receiving the placebo-suspension , the surgeon will identify the submandibular glands and inject the suspension. Placebo will be 2ml of Isotonic NaCl (0,9mg/ml) and HA 1%.
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (1)

DERIVEDGronhoj C, Jensen DH, Glovinski PV, Jensen SB, Bardow A, Oliveri RS, Specht L, Thomsen C, Darkner S, Kiss K, Fischer-Nielsen A, von Buchwald C. First-in-man mesenchymal stem cells for radiation-induced xerostomia (MESRIX): study protocol for a randomized controlled trial. Trials. 2017 Mar 7;18(1):108. doi: 10.1186/s13063-017-1856-0. PMID 28270226