Clinical trial NCT04593589: Submandibular Gland Stem Cell Transplantation
Official title: Autologous Transplantation of Adult Salivary Gland Stem Cells to Restore Submandibular Gland Function After Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Head and Neck Cancer
Keywords: Radiotherapy
Cell transplantation
Stem cell therapy
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Safety: adverse events
timeFrame: Data for assessing safety will be recorded from day 1 to 365.
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.
Secondary outcomes:
measure: Salivary flow recovery
timeFrame: Saliva measurements at 6 and 12 months and then on a yearly basis until 5 years after postoperative (chemo)radiation
measure: Impact of transplantation
timeFrame: Patient-rated outcome measures at 6 and 12 months and then on a yearly basis until 5 years after postoperative (chemo)radiation
measure: Locoregional control
timeFrame: 5 years after postoperative (chemo)radiation
measure: Overall survival and disease-free survival
timeFrame: 5 years after postoperative (chemo)radiation
measure: Rate of water diffusion in remaining submandibular gland
timeFrame: 6 and 12 months after postoperative (chemo)radiation
measure: Amount of PSMA
timeFrame: 6 and 12 months after autologous stem cell transplantation
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: UMCG
Study officials:
affiliation: UMC Groningen
name: R.J.H.M. Steenbakkers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: