Head and Neck CancerPhase 1RESTARTNCT04593589
Submandibular Gland Stem Cell Transplantation
A Phase 1 study testing Submandibular Gland Stem Cell Transplantation in people with Head and Neck Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Submandibular Gland Stem Cell Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 May 2022to 1 Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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:
Show all 9Show fewer
- basal or squamous cell carcinoma of the skin
- in situ carcinoma of the cervix;
- Females who are pregnant or lactating at entry.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
UMCG
Groningen
R.J.H.M. Steenbakkers, MD,PhD
About this study
Official title: Autologous Transplantation of Adult Salivary Gland Stem Cells to Restore Submandibular Gland Function After Radiotherapy
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
- Head and Neck Cancer
- Being tested
- Submandibular Gland Stem Cell Transplantation
- Keywords
- Radiotherapy, Cell transplantation, Stem cell therapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submandibular Gland Stem Cell TransplantationOther
Autologous transplantation of salivary stem cells (salisphere derived cells) cultured in vitro as obtained from submandibular glands after postoperative radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Transplantation | Experimental | Submandibular Gland Stem Cell Transplantation Receives: Other: Submandibular Gland Stem Cell Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: adverse events
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).
Measured: Data for assessing safety will be recorded from day 1 to 365.
Feasibility: salivary flow rate
The salivary flow rate of the remaining submandibular gland will be recorded.
Measured: 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 (6)
Salivary flow recovery
Unstimulated whole saliva, paraffin stimulated whole saliva and 5% citric acid stimulated parotid and submandibular/sublingual saliva measurements.
Measured: Saliva measurements at 6 and 12 months and then on a yearly basis until 5 years after postoperative (chemo)radiation
Impact of transplantation
Patient-rated outcome measures including various side effects related to the postoperative (chemo)radiation and Quality of Life (QoL) using internationally validated questionnaires.
Measured: Patient-rated outcome measures at 6 and 12 months and then on a yearly basis until 5 years after postoperative (chemo)radiation
Locoregional control
Locoregional control is defined as the number of patients with recurrent disease within or adjacent to the primary tumor site and regional lymph nodes after postoperative (chemo)radiation, assessed by pathology and/or oncologic imaging (CT, MRI or PET).
Measured: 5 years after postoperative (chemo)radiation
Overall survival and disease-free survival
Measured: 5 years after postoperative (chemo)radiation
Rate of water diffusion in remaining submandibular gland
The rate of water diffusion in remaining submandibular gland derived from DWI/DTI-MRI.
Measured: 6 and 12 months after postoperative (chemo)radiation
Amount of PSMA
The amount of prostate specific membrane antigen (PSMA) in the remaining submandibular gland derived from PET-CT
Measured: 6 and 12 months after autologous stem cell transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start10 May 2022
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- R.J.H.M. Steenbakkers, MD, PhD, Principal investigator, UMC Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593589
- Sponsor's protocol ID
- RT2020-04
- Other IDs
- NL75095.000.20
- Acronym
- RESTART
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2020
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Transplantation of Adult Salivary Gland Stem Cells to Restore Submandibular Gland Function After Radiotherapy
- ClinicalTrials.gov ID
- NCT04593589
- Acronym / sponsor ID
- RESTART / RT2020-04
- Conditions
- Head and Neck Cancer
- Keywords
- Radiotherapy, Cell transplantation, Stem cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transplantation | Experimental | Other: Submandibular Gland Stem Cell TransplantationSubmandibular Gland Stem Cell Transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Submandibular Gland Stem Cell TransplantationAutologous transplantation of salivary stem cells (salisphere derived cells) cultured in vitro as obtained from submandibular glands after postoperative radiotherapy | Other | Transplantation |
Primary outcome
Safety: adverse events
Time frame: Data for assessing safety will be recorded from day 1 to 365.
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).
Feasibility: salivary flow rate
Time frame: 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.
The salivary flow rate of the remaining submandibular gland will be recorded.
6 secondary outcomes
Salivary flow recovery
Time frame: Saliva measurements at 6 and 12 months and then on a yearly basis until 5 years after postoperative (chemo)radiation
Impact of transplantation
Time frame: Patient-rated outcome measures at 6 and 12 months and then on a yearly basis until 5 years after postoperative (chemo)radiation
Locoregional control
Time frame: 5 years after postoperative (chemo)radiation
Overall survival and disease-free survival
Time frame: 5 years after postoperative (chemo)radiation
Rate of water diffusion in remaining submandibular gland
Time frame: 6 and 12 months after postoperative (chemo)radiation
Amount of PSMA
Time frame: 6 and 12 months after autologous stem cell transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
R.J.H.M. Steenbakkers, MD, PhD principal investigator
UMC Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Submandibular Gland Stem Cell Transplantation in people with Head and Neck Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact R.J.H.M. Steenbakkers, MD, PhD (+31 (0)503610034, r.steenbakkers@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: adverse events (time frame: Data for assessing safety will be recorded from day 1 to 365.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.