Overview
Sponsor-declared trial summary
Xerostomia due to readiotherapy for a head & neck cancer
To evaluate the effect of two repeated intraglandular injections with ASCs, relative to placebo, in improving unstimulated whole salivary flow rate in radiation-induced xerostomia 8 months from baseline.
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Otorhinolaryngologic Diseases [C09]
- Decision date (initial)
- 2025-09-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
To evaluate the effect of two repeated intraglandular injections with ASCs, relative to placebo, in improving unstimulated whole salivary flow rate in radiation-induced xerostomia 8 months from baseline.
Secondary objectives 3
- change in stimulated whole salivary flow rate
- de novo development of drug specific antibodies
- symptoms assessed using patient reported outcomes (PRO) with focus on (a) health-related quality of life, (b) dry mouth, (c) sticky saliva, and (d) swallowing, and (e) personalized goal assessment
Conditions and MedDRA coding
Xerostomia due to readiotherapy for a head & neck cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 1. Former radiotherapy for squamous cell carcinoma, or adenocarcinoma, of the nasal sinus, larynx, pharynx, and oral cavity
- 2. WHO Performance status 0-1
- 3. Presence of xerostomia daily
- UWS of 0.05 mL/min to 0.5 ml/min
- 5. Age above 18
- 6. Informed consent
Exclusion criteria 9
- 1. Any active cancer in the previous 0,5 year (not including the head and neck cancer and basocellular carcinomas)
- 2. Xerogenic medications at inclusion
- 3. Penicillin or streptomycin allergy assessed by health personnel
- 4. Any other previous or active disease of the salivary glands (e.g. Sjögren’s Disease, sialolothiasis)
- 5. Previous submandibular surgery or biopsy
- 6. Pregnancy or planned pregnancy until 4 months after second treatment
- 7. Breastfeeding
- 8. Smoking within the last 6 months
- 9. Alcohol abuse within the last 6 months (consumption must not be above 10 units/week (Danish National board health alcohol guidelines)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary outcome measure will be unstimulated whole salivary flow rate (measured by sialometry) from baseline (t=0) to 8 months, assessed at baseline, 4, and 8 months. This domain has been chosen as whole salivary flow rate is observed to be the cardinal symptom in xerostomia[34]. The primary endpoint will be assessed as the difference between groups measured after 8 months in mL/min.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Culture expanded Adipose Derived Regenerative Cells, ADRC001
PRD10512270 · Product
- Active substance
- ADRC001
- Other product name
- ADRC001
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAGLANDULAR USE
- Max daily dose
- 1 ml millilitre(s)
- Max total dose
- 2 ml millilitre(s)
- Max treatment duration
- 4 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- OUPHET
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Joachim Hansen
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Joachim Hansen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Region Hovedstaden ORG-100003705
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | MESRIX-More_Protocol | 4 |
| Protocol (for publication) | MESRIX-More_Protocol for CTIS tracked changes | 4 |
| Recruitment arrangements (for publication) | Letter to potential participants_MESRIX-more | 2 |
| Recruitment arrangements (for publication) | Participant recruitment_mesrixmore | 4 |
| Subject information and informed consent form (for publication) | Deltagerinformation MESRIX-more | 4 |
| Subject information and informed consent form (for publication) | GRIX questionnaire | 1 |
| Subject information and informed consent form (for publication) | Sprgeskema_EORTC QOL HN35_mesrixmore | 1 |
| Synopsis of the protocol (for publication) | Protocol synopsis_mesrixmore | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-06 | Denmark | Acceptable 2025-09-05
|
2025-09-08 |