Actively Recruiting
Submandibular Gland Stem Cell Transplantation
Led by University Medical Center Groningen · Updated on 2024-10-22
18
Participants Needed
1
Research Sites
346 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Submandibular Gland Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, including at least levels Ib to IV, next to irradiation of the tumour bed and ipsilateral neck
- Age 18 years or older
- WHO performance status 0-2
- Written informed consent
You will not qualify if you...
- Primary (definitive) radiotherapy, with or without systemic treatment
- Previous radiotherapy of the head and neck region (re-irradiation)
- Positive microbiological screening for HIV types 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 or in situ carcinoma of the cervix
- Females who are pregnant or lactating at entry
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UMCG
Groningen, Netherlands
Actively Recruiting
Research Team
R
R.J.H.M. Steenbakkers, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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