Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04593589

Submandibular Gland Stem Cell Transplantation

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UMCG

Groningen, Netherlands

Location status: Recruiting

Location contact

R.J.H.M. Steenbakkers, MD,PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Submandibular Gland Stem Cell Transplantation

Other

Autologous transplantation of salivary stem cells (salisphere derived cells) cultured in vitro as obtained from submandibular glands after postoperative radiotherapy

Primary outcomes

  1. Safety: adverse events

    Time frame: Data for assessing safety will be recorded from day 1 to 365.

    The number of adverse events (AE), serious adverse events (SAE) or suspected unexpected adverse reactions (SUSAR) after autologous salivary stem cell transplantation. All possible adverse events will be scored according to the definitions of the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAEv4.0).

  2. 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.

    The salivary flow rate of the remaining submandibular gland will be recorded.

Secondary outcomes

  1. 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

    Unstimulated whole saliva, paraffin stimulated whole saliva and 5% citric acid stimulated parotid and submandibular/sublingual saliva measurements.

  2. 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

    Patient-rated outcome measures including various side effects related to the postoperative (chemo)radiation and Quality of Life (QoL) using internationally validated questionnaires.

  3. Locoregional control

    Time frame: 5 years after postoperative (chemo)radiation

    Locoregional control is defined as the number of patients with recurrent disease within or adjacent to the primary tumor site and regional lymph nodes after postoperative (chemo)radiation, assessed by pathology and/or oncologic imaging (CT, MRI or PET).

  4. Overall survival and disease-free survival

    Time frame: 5 years after postoperative (chemo)radiation

  5. Rate of water diffusion in remaining submandibular gland

    Time frame: 6 and 12 months after postoperative (chemo)radiation

    The rate of water diffusion in remaining submandibular gland derived from DWI/DTI-MRI.

  6. Amount of PSMA

    Time frame: 6 and 12 months after autologous stem cell transplantation

    The amount of prostate specific membrane antigen (PSMA) in the remaining submandibular gland derived from PET-CT

Study contacts

Contact information is provided by the study sponsor or research team.

R.J.H.M. Steenbakkers, MD, PhD

CONTACT

[email protected]

+31 (0)503610034

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: RESTART

Important dates

Study start
2022
Primary completion
2026
Study completion
2029
First posted
Oct 20, 2020
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.