Clinical trial NCT05820711: Study Transplanting Bone Marrow Cells Into Salivary Glands to Treat Dry Mouth Caused by Radiation Therapy
Official title: A Phase I Dose-Escalation Trial of Mesenchymal Stromal Cells in Patients With Xerostomia After Radiation Therapy for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Head and Neck Cancer
Xerostomia
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2023-04-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

There is no expanded access program available per this protocol.


Eligibility 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)

Primary outcomes:
measure: Safety and Tolerability: Determination of Recommended Phase 2 Dose (RP2D)
timeFrame: Up to 1 month post-injection
measure: Safety and Tolerability: Number of subjects with pain >5 on a 0-10 point scale
timeFrame: 1 month post-injection
measure: Safety and Tolerability: Number of Serious Adverse Events
timeFrame: Up to 1 month post-injection
measure: Safety and Tolerability: Number of Treatment-Emergent Pre-Specified Adverse Events
timeFrame: Up to 1 month post-injection
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline to 24 months post-injection
measure: Change in Quality of Life
timeFrame: Baseline to 24 months post-injection
measure: Change in Quality of Life
timeFrame: Baseline to 24 months post-injection
measure: Change in salivary production
timeFrame: Baseline to 24 months post-injection
measure: Shear wave velocity with acoustic radiation force impulse
timeFrame: 3, 6, and 12 months post-injection
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Randall Kimple, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Jacques Galipeau, MD
role: STUDY_DIRECTOR
References: