Clinical trial • Phase IV|Phase II • Oncology|Other

ADRC001 for Radiation-induced xerostomia (post-radiotherapy for head and neck cancer)

Phase IV|Phase II trial of ADRC001 for Radiation-induced xerostomia (post-radiotherapy for head and neck cancer).

Overview

Trial Therapeutic Area
Oncology|Other
Trial Disease
Radiation-induced xerostomia (post-radiotherapy for head and neck cancer)
Trial Stage
Phase IV|Phase II
Drug Modality
Cell therapy|Other

Key dates

Initial CTIS Submission Date
06-06-2025
First CTIS Authorization Date
08-09-2025

Trial design

Randomised, sterile isotone saline water (placebo) administered as placebo intraglandular injections (placebo comparator); active arm: culture expanded adipose derived regenerative cells, adrc001 administered as intraglandular injections (two repeated injections).-controlled Phase IV|Phase II trial across 1 site in Denmark.

Randomised
Yes
Comparator
Sterile Isotone Saline Water (placebo) administered as placebo intraglandular injections (placebo comparator); active arm: Culture expanded Adipose Derived Regenerative Cells, ADRC001 administered as intraglandular injections (two repeated injections).
Target Sample Size
100
Trial Duration For Participant
240

Eligibility

Recruits 100 Vulnerable population not selected; participants must be age above 18; informed consent required from participants (no assent procedures described)..

Pregnancy Exclusion
6. Pregnancy or planned pregnancy until 4 months after second treatment
Vulnerable Population
Vulnerable population not selected; participants must be age above 18; informed consent required from participants (no assent procedures described).

Inclusion criteria

  • {"criterion_text":"- 1.\tFormer radiotherapy for squamous cell carcinoma, or adenocarcinoma, of the nasal sinus, larynx, pharynx, and oral cavity"}
  • {"criterion_text":"- 2.\tWHO Performance status 0-1"}
  • {"criterion_text":"- 3.\tPresence of xerostomia daily"}
  • {"criterion_text":"- UWS of 0.05 mL/min to 0.5 ml/min"}
  • {"criterion_text":"- 5.\tAge above 18"}
  • {"criterion_text":"- 6.\tInformed consent"}

Exclusion criteria

  • {"criterion_text":"- 1.\tAny active cancer in the previous 0,5 year (not including the head and neck cancer and basocellular carcinomas)"}
  • {"criterion_text":"- 2.\tXerogenic medications at inclusion"}
  • {"criterion_text":"- 3.\tPenicillin or streptomycin allergy assessed by health personnel"}
  • {"criterion_text":"- 4.\tAny other previous or active disease of the salivary glands (e.g. Sjögren’s Disease, sialolothiasis)"}
  • {"criterion_text":"- 5.\tPrevious submandibular surgery or biopsy"}
  • {"criterion_text":"- 6.\tPregnancy or planned pregnancy until 4 months after second treatment"}
  • {"criterion_text":"- 7.\tBreastfeeding"}
  • {"criterion_text":"- 8.\tSmoking within the last 6 months"}
  • {"criterion_text":"- 9.\tAlcohol abuse within the last 6 months (consumption must not be above 10 units/week (Danish National board health alcohol guidelines)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Unstimulated whole salivary flow rate measured by sialometry at baseline, 4 months, and 8 months; primary analysis is difference between groups at 8 months in mL/min."}

Recruitment

Planned Sample Size
100
Recruitment Window Months
47
Consent Approach
Informed consent is required from each participant (inclusion criterion 'Informed consent'); participants must be aged above 18. A subject information and informed consent form is listed among documents (e.g. 'Deltagerinformation MESRIX-more'). No assent process or languages are specified in the record.

Geography

Total Number Of Sites
1
Total Number Of Participants
100

Denmark

Earliest CTIS Part Ii Submission Date
03-09-2025
Latest Decision Or Authorization Date
08-09-2025
Processing Time Days
5
Number Of Sites
1
Number Of Participants
100

Sites

Site Name
Rigshospitalet
Department Name
Department of otorhinolaryngology, Head and Neck surgery
Principal Investigator Name
Joachim Hansen
Principal Investigator Email
joachim.hansen.01@regionh.dk
Contact Person Name
Joachim Hansen
Contact Person Email
joachim.hansen.01@regionh.dk
Number Of Participants
100

Sponsor

Primary sponsor

Full Name
Rigshospitalet
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"Region Hovedstaden","duties_or_roles":"sponsor duties code: 1; contact phone +4538635680; email gcp-enheden.bispebjerg-frederiksberg-hospitaler@regionh.dk","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Culture expanded Adipose Derived Regenerative Cells, ADRC001
Active Substance
ADRC001
Modality
Cell therapy
Routes Of Administration
INTRAGLANDULAR USE
Route
INTRAGLANDULAR USE
Frequency
Two repeated intraglandular injections
Maximum Dose
2 ml
Investigational Product Name
Sterile Isotone Saline Water
Modality
Other

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