Trials / Unknown
UnknownNCT03874572
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
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Rigshospitalet, Denmark · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
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 the submandibular and parotid glands of the patients with radiation-induced hyposalivation and xerostomia after radiation for a oropharyngeal squamous cell carcinoma
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 submandibular and parotid glands. The trial will be Good Clinical Practice (GCP) Monitored. From healthy donors, MSCs will be produced at a Good Manufacturing Practice (GMP) Facility. The patients will be followed for four months for safety, tolerability, and efficacy registration. Changes in quality of life, unstimulated, and stimulated whole saliva flow rate, salivary gland function will be assessed. Immune response towards receiving allogeneic MSCs will be evaluated in plasma and saliva. Changes in the composition and quality of the whole saliva will be investigated. Saliva from the participants will altså be compared to saliva from ten healthy controls.
Conditions
- Xerostomia Due to Radiotherapy
- Hyposalivation
- Xerostomia
- Oropharynx Cancer
- Salivary Gland Diseases
- Dry Mouth
- Mesenchymal Stem Cells
- Mesenchymal Stromal Cells
- Stem Cells
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Allogeneic adipose derived stem/stromal cells | Culture expanded allogeneic adipose derived stem/stromal cells |
Timeline
- Start date
- 2019-03-18
- Primary completion
- 2020-06-22
- Completion
- 2025-12-01
- First posted
- 2019-03-14
- Last updated
- 2021-01-29
Locations
2 sites across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03874572. Inclusion in this directory is not an endorsement.