Clinical trial · Interventional
Salivary Gland Autotransplantation for Treatment of XRT Induced Xerostomia
Salivary Gland Autotransplantation of Marrow Mesenchymal Stromal Cells for Treatment of Radiation-induced Xerostomia - FDA IND (Investigational New Drug) Enabling Studies
- 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)
Xerostomia, or dry mouth, is a common side effect of head neck radiation. Current treatment options for radiation-induced xerostomia are generally supportive in nature. Most of these supportive interventions do not reverse xerostomia and are palliative in intent. The investigators propose that autotransplantation of marrow-derived mesenchymal stromal cells (MSCs) in salivary glands post-RT or post-chemoradiation therapy (CRT) may provide an innovative remedy to treat xerostomia and restore quality of life. Participants can expect to be on study for up to 6 months.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Xerostomia | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bone Marrow Aspiration | Procedure | — | UNRESOLVED |
| Quality of Life Instruments | Other | — | UNRESOLVED |
| Salivary Assay | Other | — | UNRESOLVED |
| Ultrasound Imaging of Salivary Glands | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants with Xerostomia
- description
- Salivary sample collection, quality of life survey, salivary gland imaging, bone marrow aspiration
- interventionNames
- Procedure: Bone Marrow Aspiration
- Diagnostic Test: Ultrasound Imaging of Salivary Glands
- Other: Salivary Assay
- Other: Quality of Life Instruments
Primary outcomes (1)
- measure
- Number of Participant's whose Marrow-Derived MSCs Can be Expanded in vitro to > 50 million cells within two weeks
- timeFrame
- Up to 1 day to collect, subsequently cultured in vitro for up to 2 weeks
- description
- The feasibility of in vitro expansion of MSCs derived from marrow aspirates collected from participants will be determined by if they can be culture expanded for up to two weeks to generate \>50 million MSCs per donor. Feasibility will reported as the number of participants whose marrow-derived MSCs can be expanded in vitro to \> 50 million cells within two weeks.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * Participants ≥2 years from completion of chemoradiation therapy or radiation therapy (N=6) with subjective complaint of xerostomia or with no diagnosis of HNC (N=5) * Karnofsky ≥ 60, participant eligible for bone marrow aspirate with wakeful anesthesia * Not pregnant * Willing and able to give informed consent * non-HNC participants only need to meet the following applicable inclusion criteria * No history of radiation to the salivary glands * Willing and able to give informed consent Exclusion Criteria: * Salivary gland disease (e.g., sialolithiasis)
References
Publications (0)
Data not yet available