Transplanting stem cells from the submandibular gland to treat head and neck cancer
Autologous Transplantation of Adult Salivary Gland Stem Cells to Restore Submandibular Gland Function After Radiotherapy
This study is testing if transplanting stem cells from the salivary glands can help people with head and neck cancer recover their saliva production and improve their quality of life after treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 1 site (Groningen) |
| Trial ID | NCT04593589 on ClinicalTrials.gov |
What this trial studies
This phase I study aims to evaluate the safety and feasibility of using autologous salivary gland stem cell transplantation in patients with head and neck cancer following postoperative radiotherapy or chemoradiation. The intervention involves harvesting stem cells from the submandibular gland and transplanting them to potentially restore salivary function and improve quality of life. The study will include patients with squamous cell carcinoma who have undergone tumor resection and subsequent radiation treatment. The primary focus is on assessing the safety of this innovative approach in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with squamous cell carcinoma of the oral cavity who have undergone surgical resection and postoperative radiotherapy.
Not a fit: Patients who have received primary radiotherapy or have systemic diseases affecting salivary gland function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve salivary gland function and quality of life for patients suffering from the side effects of head and neck cancer treatments.
How similar studies have performed: While this approach is novel, similar studies involving stem cell therapies for other conditions have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Groningen
- Umcg — Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: R.J.H.M. Steenbakkers, MD, PhD — UMC Groningen
- Study coordinator: R.J.H.M. Steenbakkers, MD, PhD
- Email: r.steenbakkers@umcg.nl
- Phone: +31 (0)503610034
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.