Clinical Trials Logo
  1. Home
  2. Salivary Gland Diseases
  3. NCT03874572

Allogeneic Mesenchymal Stem Cells for Radiation-induced Hyposalivation and Xerostomia/Dry Mouth — MESRIX-SAFETY  

Xerostomia Clinical Trial

Official 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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03874572
Study type Interventional
Source Rigshospitalet, Denmark
Contact
Status Active, not recruiting
Phase Phase 1
Start date March 18, 2019
Completion date December 1, 2025
View Details
See also
  Status Clinical Trial Phase
Completed NCT05342272 - Comparison of Gum® HydralTM Moisturizing Gel and Biotene® Oral Gel in Dry Mouth Sensation Reduction Phase 3
Completed NCT03302676 - The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors N/A
Completed NCT02375451 - Effect of Childhood Radioiodine Therapy on Salivary Function N/A
Completed NCT01272570 - Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors N/A
Completed NCT00656513 - Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer Phase 2/Phase 3
Completed NCT00911768 - Effect of Korean Red Ginseng (KRG) on Dry Mouth Phase 4
Completed NCT00332618 - Efficacy Study of Oxygenated Glycerol Triesters to Treat Xerostomia Phase 2
Completed NCT03494985 - A Clinical Study to Evaluate the Efficacy of Three Dry Mouth Relief Products Versus Water N/A
Completed NCT05058430 - SaliPen Human Factors Study for OTC Labeling N/A
Recruiting NCT02705937 - Early Phase Study Comparing the Effectiveness of a Dairy Product With the Reference Treatment Aequasyal® on Dry Mouth Symptoms in Patients Suffering From Xerostomia Caused by Psychotropic Medications. N/A
Completed NCT05247008 - Effectiveness of Thyme Honey in Management of Xerostomia in ESRD N/A
Recruiting NCT03632096 - Photobiomodulation in Salivary Production of Patients With Xerostomy Phase 2
Not yet recruiting NCT04323384 - The Effect of Biotene® on the Symptoms of Xerostomia and Mastication and Swallowing N/A
Not yet recruiting NCT03530735 - Finger-prick Autologous Blood (FAB) for Use in Dry Mouth N/A
Active, not recruiting NCT03176368 - Coconut Oil: Managing Radiation-Induced Xerostomia N/A
Enrolling by invitation NCT06122636 - Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC N/A
Completed NCT03611283 - Topical Management of Xerostomia With Dry Mouth Products N/A
Completed NCT02682199 - Prospective Evaluation of Patient Reported Xerostomia After Whole Brain Radiation
Withdrawn NCT01960101 - Development of a Milk Product Substitution for Patients Suffering From Xerostomia Caused by Medication N/A
Completed NCT02317172 - Efficacy of Novel Edible Gel-based Artificial Saliva in Thai Geriatric Populations With Systemic Diseases N/A