Submandibular Gland Stem Cell Transplantation (RESTART)

University Medical Center Groningen (UMCG)

Status and phase

Enrolling

Phase 1

Conditions

Head and Neck Cancer

Treatments

Other: Submandibular Gland Stem Cell Transplantation

Study type

Interventional

Funder types

Other

Identifiers

NCT04593589

RT2020-04

NL75095.000.20 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

18 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.