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Recruiting NCT04593589

Submandibular Gland Stem Cell Transplantation

Phase I Interventional Head and Neck Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Submandibular Gland Stem Cell Transplantation.
Who it may be relevant to
Registry conditions: Head and Neck Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Autologous Transplantation of Adult Salivary Gland Stem Cells to Restore Submandibular Gland Function After Radiotherapy

Overview

This study is a phase I safety and feasibility study to treat head and neck cancer patients with autologous salivary gland stem cell transplantation after postoperative (chemo)radiotherapy.

Interventions

  • Other Submandibular Gland Stem Cell Transplantation
    Autologous transplantation of salivary stem cells (salisphere derived cells) cultured in vitro as obtained from submandibular glands after postoperative radiotherapy

Primary outcome measures

  • Safety: adverse events [Time frame: Data for assessing safety will be recorded from day 1 to 365.]
  • Feasibility: salivary flow rate [Time frame: Data for assessing feasibility will be recorded 6 and 12 months after autologous stem cell transplantation to assess if salivary flow will be increased compared to salivary flow before transplantation.]
Secondary outcome measures (6)
  • Salivary flow recovery [Time frame: Saliva measurements at 6 and 12 months and then on a yearly basis until 5 years after postoperative (chemo)radiation]
  • Impact of transplantation [Time frame: Patient-rated outcome measures at 6 and 12 months and then on a yearly basis until 5 years after postoperative (chemo)radiation]
  • Locoregional control [Time frame: 5 years after postoperative (chemo)radiation]
  • Overall survival and disease-free survival [Time frame: 5 years after postoperative (chemo)radiation]
  • Rate of water diffusion in remaining submandibular gland [Time frame: 6 and 12 months after postoperative (chemo)radiation]
  • Amount of PSMA [Time frame: 6 and 12 months after autologous stem cell transplantation]

Eligibility criteria

Inclusion criteria

  • Squamous cell carcinoma (SCC) originating from the mucosa of the oral cavity;
  • Primary resection of tumour including an electively or therapeutic ipsilateral neck dissection (at least levels Ib to III, including the submandibular gland).
  • Postoperative radiotherapy or chemoradiation, including prophylactic or therapeutic irradiation of the contralateral side of the neck (where the remaining submandibular gland is), including at least levels Ib to IV), next to irradiation of the tumour bed and ipsilateral neck (current standard);
  • Age ≥ 18 years;
  • WHO performance 0-2;
  • Written informed consent;

Exclusion criteria

  • Primary (definitive) radiotherapy, with or without systemic treatment;
  • Previous radiotherapy of the head and neck region (re-irradiation);
  • Positive microbiological screening for Human Immunodeficiency Virus type 1 and 2, hepatitis B and C virus and Treponema pallidum.
  • Presence of systemic disease known to affect salivary gland functioning (e.g., Sjögren's syndrome);
  • Known allergy to mice and gentamicin
  • History within the past five years of malignancies other than:
  • basal or squamous cell carcinoma of the skin
  • in situ carcinoma of the cervix;
  • Females who are pregnant or lactating at entry.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • UMCG — Groningen

Identifiers

NCT: NCT04593589 · RT2020-04 · NL75095.000.20

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗