Xerostomia Clinical Trial
Official title:
UW23129: A Phase I Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Medical Xerostomia
The goal of this clinical trial is to evaluate the safety and tolerability of injecting certain cells produced in bone marrow called mesenchymal stromal cells (MSCs) into salivary glands. The main question it aims to answer is whether injection of MSCs into salivary glands results in any improvement in dry mouth. Participants will: - have bone marrow collected using a needle - undergo a salivary gland ultrasound - complete questionnaires - receive an injection of the bone marrow cells into a salivary gland
This single-center phase I dose-escalation with expansion cohort, open label, non-randomized, non-placebo controlled, single group assignment study will assess the safety and tolerability of mesenchymal stromal cells (MSCs) for treatment of xerostomia, focusing on xerostomia with inflammatory etiology (e.g., Sjögren's disease [SjD], graft-versus-host disease [GVHD]). An initial cohort of subjects (n=6) will receive a unilateral injection of MSCs at dose level 0. If unilateral treatment is tolerated, a dose escalation cohort (n=8-18) will receive bilateral injection of MSCs. Dose escalation will proceed using a standard 3+3 design and once the recommended phase II dose (RP2D) is defined, 12 additional patients will be accrued to the expansion phase. Following the completion of screening/baseline procedures, eligible participants will undergo bone marrow aspiration in order to obtain MSCs. The MSC investigational product will be injected into one or both submandibular glands under local anesthesia at the interventional visit. ;
| 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 |