Clinical trial · Interventional
Allogeneic Mesenchymal Stem Cells for Radiation-induced Hyposalivation and Xerostomia/Dry Mouth
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dry Mouth | — | UNRESOLVED | — |
| Hyposalivation | — | UNRESOLVED | — |
| Mesenchymal Stem Cells | — | UNRESOLVED | — |
| Mesenchymal Stromal Cells | — | UNRESOLVED | — |
| Oropharynx Cancer | Malignant Oropharyngeal Neoplasm | ALIAS | 0.90 |
| Salivary Gland Diseases | — | UNRESOLVED | — |
| Stem Cells | — | UNRESOLVED | — |
| Xerostomia | — | UNRESOLVED | — |
| Xerostomia Due to Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic adipose derived stem/stromal cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Allogeneic mesenchymal stem/stromal cell therapy
- description
- Treatment with intra-glandular Injections of allogeneic adipose derived stem cells
- interventionNames
- Biological: Allogeneic adipose derived stem/stromal cells
Primary outcomes (1)
- measure
- Safety: Number of patients with serious adverse events
- timeFrame
- 4 months
- description
- Registration of number of patients with serious adverse events in a 4 months follow-up period
Secondary outcomes (9)
- measure
- Immune reponse :Development of donor specific antibodies
- timeFrame
- 4 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available