Transplanting stem cells from the submandibular gland to treat head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I study aims to evaluate the safety and feasibility of using autologous salivary gland stem cell transplantation in patients with head and neck cancer following postoperative radiotherapy or chemoradiation. The intervention involves harvesting stem cells from the submandibular gland and transplanting them to potentially restore salivary function and improve quality of life. The study will include patients with squamous cell carcinoma who have undergone tumor resection and subsequent radiation treatment. The primary focus is on assessing the safety of this innovative approach in a clinical setting.

Why it matters

Who can join: the full rules

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.

Where it's running

• Umcg
  Groningen, Netherlands Recruiting

Study contacts

• Principal investigator: R.J.H.M. Steenbakkers, MD, PhD — UMC Groningen
• Study coordinator: R.J.H.M. Steenbakkers, MD, PhD
• Email: r.steenbakkers@umcg.nl
• Phone: +31 (0)503610034

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.