Study Transplanting Bone Marrow Cells Into Salivary Glands to Treat Dry Mouth Caused by Radiation Therapy

University of Wisconsin (UW)

Status and phase

Enrolling

Phase 1

Conditions

Xerostomia

Head and Neck Cancer

Treatments

Drug: MSC

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05820711

A533300 (Other Identifier)

Protocol Version 9/13/2024 (Other Identifier)

2023-0194

SMPH/HUMAN ONCOLOGY/HUMAN ONCO (Other Identifier)

UW21144 (Other Identifier)

4UH3DE030431-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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