Study Transplanting Bone Marrow Cells Into Salivary Glands to Treat Dry Mouth Caused by Radiation Therapy
Study Details
Study Description
Brief Summary
The goal of this clinical research study is to evaluate the safety and tolerability of injecting certain cells that you produce in your bone marrow called mesenchymal stem cells (MSCs) into your salivary glands.
Participants will have head and neck cancer that was treated with radiation therapy, and in this study will:
-
Undergo a collection of bone marrow using a needle;
-
Donate saliva;
-
Undergo a salivary gland ultrasound; and,
-
Complete questionnaires that ask about dry mouth
Participants can expect to be in this study for up to 30 months.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mesenchymal Stem Cell (MSC) injection
|
Drug: MSC
Injection of MSCs into submandibular glands at pre-specified dose level:
Dose -1: 5 (4 - 6) x10^6 MSCs (to be used only if Dose level 1 is not tolerated) per gland (0.5 ml)
Dose 0: 10 (8 - 12) x10^6 MSCs per gland (1 ml)
Dose 1: 20 (16 - 24) x10^6 MSCs per gland (2 ml)
|
Outcome Measures
Primary Outcome Measures
- Safety and Tolerability: Determination of Recommended Phase 2 Dose (RP2D) [Up to 1 month post-injection]
RP2D (also called the maximum tolerated dose) of MSCs determined by the proportion of subjects experiencing dose limiting toxicity (DLT)
- Safety and Tolerability: Number of subjects with pain >5 on a 0-10 point scale [1 month post-injection]
Incidence of pain assessed as greater than 5 on standard 0-10 point pain scale (0=not at all to 10=worst pain imaginable)
- Safety and Tolerability: Number of Serious Adverse Events [Up to 1 month post-injection]
Incidence of any serious adverse event
- Safety and Tolerability: Number of Treatment-Emergent Pre-Specified Adverse Events [Up to 1 month post-injection]
Incidence of pre-specified adverse events
Secondary Outcome Measures
- Change in Quality of Life [Baseline to 24 months post-injection]
Efficacy of MSC assessed through University of Michigan Xerostomia Related Quality of Life (XeQOL) scale, which is a 15-item assessment scale with 4 domains. The score is the average of all responses of all domains and can range from 0 to 4, where higher scores indicate increased xerostomia burden.
- Change in Quality of Life [Baseline to 24 months post-injection]
Efficacy of MSC assessed through the MD Anderson Dysphagia Index (MDADI), which is a 20-item questionnaire designed for evaluating the impact of dysphagia (swallowing ability). Scores range from 20 (extremely low functioning) to 100 (high functioning).
- Change in Quality of Life [Baseline to 24 months post-injection]
Efficacy of MSC assessed through VAS xerostomia questionnaire, which is an 8-item questionnaire that measures the perception of dry mouth. Scores range from 0-10, with 0 being low dryness and 10 being high dryness.
- Change in salivary production [Baseline to 24 months post-injection]
Saliva production will be measured by having participants chew inert gum base to the pace of a metronome (70 beats per minute) while expectorating saliva (without swallowing) into the saliva collection aid for 5 minutes total40. Cryovials will be weighed before and after collection and the difference in weight (g) will represent the amount of saliva produced in 5 minutes for each condition.
- Shear wave velocity with acoustic radiation force impulse [3, 6, and 12 months post-injection]
Assess imaging characteristics of submandibular glands after MSC, measured by ultrasound
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | United States | 53705 |
Sponsors and Collaborators
- University of Wisconsin, Madison
- National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
- Principal Investigator: Randall Kimple, MD, PhD, University of Wisconsin, Madison
- Study Director: Jacques Galipeau, MD, University of Wisconsin, Madison
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-0194
- UW21144
- SMPH/HUMAN ONCOLOGY/HUMAN ONCO
- Protocol Version 3/1/2023