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| ID | Type | Description | Link |
|---|---|---|---|
| UW21144 | Other Identifier | UW Madison | |
| SMPH/HUMAN ONCOLOGY/HUMAN ONCO | Other Identifier | UW Madison | |
| Protocol Version 9/13/2024 | Other Identifier | UW Madison | |
| 4UH3DE030431-02 | U.S. NIH Grant/Contract | View source | |
| A533300 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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:
Participants can expect to be in this study for up to 30 months.
There is no expanded access program available per this protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal Stem Cell (MSC) injection | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSC | Drug | Injection of MSCs into submandibular glands at pre-specified dose level:
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability: Determination of Recommended Phase 2 Dose (RP2D) | RP2D (also called the maximum tolerated dose) of MSCs determined by the proportion of subjects experiencing dose limiting toxicity (DLT) | Up to 1 month post-injection |
| Safety and Tolerability: Number of subjects with pain >5 on a 0-10 point scale | Incidence of pain assessed as greater than 5 on standard 0-10 point pain scale (0=not at all to 10=worst pain imaginable) | 1 month post-injection |
| Safety and Tolerability: Number of Serious Adverse Events | Incidence of any serious adverse event | Up to 1 month post-injection |
| Safety and Tolerability: Number of Treatment-Emergent Pre-Specified Adverse Events | Incidence of pre-specified adverse events | Up to 1 month post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life | 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. | Baseline to 24 months post-injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randall Kimple, MD, PhD | University of Wisconsin, Madison | Principal Investigator |
| Jacques Galipeau, MD | University of Wisconsin, Madison | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53705 | United States |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
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| Change in Quality of Life | 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). | Baseline to 24 months post-injection |
| Change in Quality of Life | 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. | Baseline to 24 months post-injection |
| Change in salivary production | 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. | Baseline to 24 months post-injection |
| Shear wave velocity with acoustic radiation force impulse | Assess imaging characteristics of submandibular glands after MSC, measured by ultrasound | 3, 6, and 12 months post-injection |
| D009057 |
| Stomatognathic Diseases |