Submandibular Gland Stem Cell Transplantation

Last updated: October 18, 2024
Sponsor: University Medical Center Groningen
Overall Status: Active - Recruiting

Phase

1

Condition

Head And Neck Cancer

Nasopharyngeal Cancer

Human Papilloma Virus (Hpv)

Treatment

Submandibular Gland Stem Cell Transplantation

Clinical Study ID

NCT04593589
RT2020-04
NL75095.000.20
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Squamous cell carcinoma (SCC) originating from the mucosa of the oral cavity;

  • Primary resection of tumour including an electively or therapeutic ipsilateral neckdissection (at least levels Ib to III, including the submandibular gland).

  • Postoperative radiotherapy or chemoradiation, including prophylactic or therapeuticirradiation of the contralateral side of the neck (where the remaining submandibulargland is), including at least levels Ib to IV), next to irradiation of the tumourbed and ipsilateral neck (current standard);

  • Age ≥ 18 years;

  • WHO performance 0-2;

  • Written informed consent;

Exclusion

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.

Study Design

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: Submandibular Gland Stem Cell Transplantation
Phase: 1
Study Start date:
May 10, 2022
Estimated Completion Date:
January 01, 2029

Connect with a study center

  • UMCG

    Groningen,
    Netherlands

    Active - Recruiting

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