Mesenchymal Stemcells for Radiation Induced Xerostomia

NCT02513238 | Completed Phase 2 Results DMC

• 1 other identifier: 1406653
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Xerostomia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events as a Measure of Safety

  Criteria for Adverse Events (CTCAE). Since this is a local treatment with MSCs the primary safety measures are: All measures of adverse events will be graded according to Common Terminology

  4 months

Study Arms (2)

Stemcells injected into submandibularis

ACTIVE COMPARATOR

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.

Drug: Mesenchymal stem cell

Saltwater injected into submandibularis

PLACEBO COMPARATOR

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%.

Drug: Isotonic NaCl

Interventions

Mesenchymal stem cell DRUG

Stemcells injected into submandibularis

Stemcells injected into submandibularis

Isotonic NaCl DRUG

Saltwater injected into submandibularis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previous radiotherapy for HPV-positive oropharyngeal head and neck cancer with bilateral irradiation of the neck.
• 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

You may not qualify if:

• 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
• Treatment with anticoagulant that cannot be stopped during the intervention period.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Related Publications (1)

• Gronhoj 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 DERIVED

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Principal Investigator, Mesrix
• Organization: Rigshospitalet

c.gronhoj@gmail.com

26276374

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 31, 2015
• Study Start: August 8, 2015
• Primary Completion: April 6, 2017
• Study Completion: April 6, 2017
• Last Updated: December 28, 2022
• Results First Posted: December 28, 2022

Record last verified: 2022-11