Autologous Transplantation of Adult Salivary Gland Stem Cells to Restore Submandibular Gland Function after Radiotherapy

Recruiting

Conditions: Head and neck cancer
Irradiated salivary gland

Registration Number: NL-OMON49128

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 18

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)
- Use of Beta-blockers (inhibit stem cells growth)
- History within the past five years of malignancies other than:
o basal or squamous cell carcinoma of the skin
o in situ carcinoma of the cervix
- Females who are pregnant or lactating at entry

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the study is to test the safety and the feasibility of<br /><br>autologous salivary gland stem cell transplantation of the submandibular gland.<br /><br>For safety, the number of adverse events (AE), serious adverse events (SAE) or<br /><br>suspected unexpected adverse reactions (SUSAR) after autologous salivary stem<br /><br>cell transplantation, will be recorded between days 1 to 365. All possible<br /><br>adverse events will be scored according to the definitions of the Common<br /><br>Toxicity Criteria for Adverse Events version 4.0 (CTCAEv4.0).<br /><br>For feasibility, salivary flow rate of the remaining submandibular gland will<br /><br>be recorded 6 months and 12 months after autologous stem cell transplantation.</p><br>

Secondary Outcome Measures