Status:
UNKNOWN
Allogeneic Mesenchymal Stem Cells for Radiation-induced Hyposalivation and Xerostomia/Dry Mouth
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Xerostomia Due to Radiotherapy
Hyposalivation
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
An investigator-initiated, non-randomized, open label study to investigate the safety, feasibility and tolerability of intraglandular injection of allogeneic mesenchymal stem/stromal cells (MSCs) into...
Detailed Description
Patients with previous oropharyngeal cancer and radiation-induced hyposalivation and xerostomia (dry mouth syndrome) will receive intraglandular injections of allogeneic adipose-derived MSCs into the ...
Eligibility Criteria
Inclusion
- Age between 18-75 years
- Previous radiotherapy +/- chemotherapy for OPSCC stage I- II (UICC-8, 2017)
- 2 years' follow-up without recurrence
- Clinically reduced salivation and hyposalivation, evaluated by a screening
- Unstimulated salivary flow rate between 0.2mL/min and 0.05mL/min
- Grade 2-3 xerostomia (CTCAEv5.0)
- WHO Performance status (PS) 0-1
- Informed consent
Exclusion
- Any cancer in the previous 4 years (not including OPSCC and basocellular carcinomas)
- Xerogenic medications
- Penicillin or Streptomycin allergy
- Any other diseases of the salivary glands, e.g. Sjögren's syndrome or sialolithiasis
- Previous parotid or submandibular gland surgery
- Previous treatment with any type of stem cells
- Breastfeeding, Pregnancy or planned pregnancy within the next 2 years
- Smoking within the previous 6 months.
- Alcohol abuse (consumption must not exceed 7 units/week for women and 14 units/week for men (Danish National board health alcohol guidelines3)
- Any other disease/condition judged by the investigator to be grounds for exclusion
Key Trial Info
Start Date :
March 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03874572
Start Date
March 18 2019
End Date
December 1 2025
Last Update
January 29 2021
Active Locations (2)
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1
Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen
Copenhagen, Denmark, 2100
2
Department of Otolaryngology, Rigshospitalet
Copenhagen, Denmark, 2100