Clinical trial · Interventional
Submandibular Gland Stem Cell Transplantation
Autologous Transplantation of Adult Salivary Gland Stem Cells to Restore Submandibular Gland Function After Radiotherapy
NCT04593589CI-TRIAL-00081806RESTARTrecruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Submandibular Gland Stem Cell Transplantation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transplantation
- description
- Submandibular Gland Stem Cell Transplantation
- interventionNames
- Other: Submandibular Gland Stem Cell Transplantation
Primary outcomes (2)
- measure
- Safety: adverse events
- timeFrame
- Data for assessing safety will be recorded from day 1 to 365.
- description
- The number of adverse events (AE), serious adverse events (SAE) or suspected unexpected adverse reactions (SUSAR) after autologous salivary stem cell transplantation. All possible adverse events will be scored according to the definitions of the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAEv4.0).
- measure
- Feasibility: salivary flow rate
- timeFrame
- Data for assessing feasibility will be recorded 6 and 12 months after autologous stem cell transplantation to assess if salivary flow will be increased compared to salivary flow before transplantation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.