RecruitingPhase 1NCT04593589
Submandibular Gland Stem Cell Transplantation
Autologous Transplantation of Adult Salivary Gland Stem Cells to Restore Submandibular Gland Function After Radiotherapy
Sponsor
University Medical Center Groningen
Enrollment
18 participants
Start Date
May 10, 2022
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria9
- 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.
Interventions
OTHERSubmandibular Gland Stem Cell Transplantation
Autologous transplantation of salivary stem cells (salisphere derived cells) cultured in vitro as obtained from submandibular glands after postoperative radiotherapy
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04593589
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