Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
18 participants
INTERVENTIONAL
2022-05-10
2029-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Transplantation
Submandibular Gland Stem Cell Transplantation
Submandibular Gland Stem Cell Transplantation
Autologous transplantation of salivary stem cells (salisphere derived cells) cultured in vitro as obtained from submandibular glands after postoperative radiotherapy
Interventions
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Submandibular Gland Stem Cell Transplantation
Autologous transplantation of salivary stem cells (salisphere derived cells) cultured in vitro as obtained from submandibular glands after postoperative radiotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University Medical Center Groningen
OTHER
Responsible Party
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Principal Investigators
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R.J.H.M. Steenbakkers, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Groningen
Locations
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UMCG
Groningen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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R.J.H.M. Steenbakkers, MD,PhD
Role: primary
Other Identifiers
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NL75095.000.20
Identifier Type: REGISTRY
Identifier Source: secondary_id
RT2020-04
Identifier Type: -
Identifier Source: org_study_id
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