Xerostomia Clinical Trial
— MESRIX-SAFETYOfficial title:
A Phase I Open Label Study Evaluating the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells for Radiation-induced Hyposalivation and Xerostomia in Previous Oropharynx Cancer Patients
Verified date | September 2020 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 the submandibular and parotid glands of the patients with radiation-induced hyposalivation and xerostomia after radiation for a oropharyngeal squamous cell carcinoma
Status | Active, not recruiting |
Enrollment | 10 |
Est. completion date | December 1, 2025 |
Est. primary completion date | June 22, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Age between 18-75 years 2. Previous radiotherapy +/- chemotherapy for OPSCC stage I- II (UICC-8, 2017) 3. 2 years' follow-up without recurrence 4. Clinically reduced salivation and hyposalivation, evaluated by a screening 5. Unstimulated salivary flow rate between 0.2mL/min and 0.05mL/min 6. Grade 2-3 xerostomia (CTCAEv5.0) 7. WHO Performance status (PS) 0-1 8. Informed consent Exclusion Criteria: 1. Any cancer in the previous 4 years (not including OPSCC and basocellular carcinomas) 2. Xerogenic medications 3. Penicillin or Streptomycin allergy 4. Any other diseases of the salivary glands, e.g. Sjögren's syndrome or sialolithiasis 5. Previous parotid or submandibular gland surgery 6. Previous treatment with any type of stem cells 7. Breastfeeding, Pregnancy or planned pregnancy within the next 2 years 8. Smoking within the previous 6 months. 9. Alcohol abuse (consumption must not exceed 7 units/week for women and 14 units/week for men (Danish National board health alcohol guidelines3) 10. Any other disease/condition judged by the investigator to be grounds for exclusion |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Otolaryngology, Rigshospitalet | Copenhagen | |
Denmark | Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety: Number of patients with serious adverse events | Registration of number of patients with serious adverse events in a 4 months follow-up period | 4 months | |
Secondary | Immune reponse :Development of donor specific antibodies | Registration of development of tissue antibodies towards donor cells | 4 months | |
Secondary | Efficacy: Change in Unstimulated Whole Salivary flow rate | Unstimulated whole saliva flow rate is assessed by sialometry | 4 months | |
Secondary | Efficacy: Change in Stimulated Whole Salivary flow rate | Unstimulated whole saliva flow rate is assessed by sialometry | 4 months | |
Secondary | Efficacy: Change in quality of life | Change in quality of life evaluted by QLQ-H&N-35 and XQ questionnaires | 4 months | |
Secondary | Efficacy: Salivary gland function | Assessed by salivary gland 99mTc scintigraphy | 4 months | |
Secondary | Efficacy: Change in Saliva composition | Change in inorganic saliva composition | 4 months | |
Secondary | Efficacy: Change in Saliva Proteomics | Change in Saliva proteomics | 4 months | |
Secondary | Efficacy: Change in RNA in Saliva | Change in RNA in saliva | 4 months | |
Secondary | Immune reponse | Reactions in plasma and saliva will be assessed | 4 months |
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