Transplanting bone marrow cells into salivary glands to treat dry mouth from radiation therapy
A Phase I Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Xerostomia After Radiation Therapy for Head and Neck Cancer
This study is testing if injecting special cells from bone marrow into the salivary glands can help people with dry mouth caused by radiation therapy for head and neck cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT05820711 on ClinicalTrials.gov |
What this trial studies
This clinical research evaluates the safety and tolerability of injecting mesenchymal stem cells (MSCs) derived from bone marrow into the salivary glands of patients who have experienced dry mouth (xerostomia) following radiation therapy for head and neck cancer. Participants will undergo bone marrow collection, saliva donation, salivary gland ultrasounds, and complete questionnaires regarding their dry mouth symptoms. The study aims to assess the potential of MSCs to restore salivary function in these patients over a period of up to 30 months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 with a history of head and neck cancer treated with radiation and currently experiencing xerostomia.
Not a fit: Patients with existing salivary gland diseases, such as sialolithiasis, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients suffering from dry mouth due to radiation therapy.
How similar studies have performed: While this approach is innovative, similar studies using MSCs for tissue regeneration have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * History of histological diagnosis of head and neck cancer (HNC) that was treated with radiation therapy and currently clinically or radiologically no evidence of disease (NED) * Xerostomia, defined as patient reported salivary function (pre-treatment) ≤ 80% of healthy (pre-radiation) * ≥ 18 years of age, ≤ 90 years of age. * Patients ≥ 2 years from completion of radiation therapy for HNC * Karnofsky performance status ≥ 70, patient eligible for bone marrow aspirate with wakeful anesthesia * Willing and able to give informed consent * Radiographically confirmed submandibular gland(s) Exclusion Criteria: * Salivary gland disease (i.e., sialolithiasis)
Where this trial is running
Madison, Wisconsin
- University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Randall Kimple, MD, PhD — University of Wisconsin, Madison
- Study coordinator: Cancer Connect
- Email: clinicaltrials@cancer.wisc.edu
- Phone: 800-622-8922
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.