MSC in Patients With Xerostomia Post XRT in Head and Neck Cancer

Phase 1 Completed 6 enrolled University of Wisconsin, Madison National Institute of Dental and Craniofacial Research (NIDCR) · collab

NaSingle-groupOpen-labelTreatment

Summary

This is a single center pilot study designed to determine the safety and tolerability of autologous bone marrow-derived Mesenchymal Stromal Cells (MSCs) in patients with xerostomia (dry mouth) after undergoing radiation therapy (XRT) for head and neck cancer (HNC). Up to 12 participants will be enrolled and can expect to be on study for up to 2 years.

Timeline

Start: 2022-02-18
Primary completion: 2022-11-22
Completion: 2026-05-20

Publications

Blitzer GC, Glazer T, Burr A, Gustafson S, Ganz O, Meyers R, McDowell KA, Nickel KP, Mattison RJ, Weiss M, Chappell R, Rogus-Pulia NM, Galipeau J, Kimple RJ. Marrow-Derived Autologous Stromal Cells for the Restoration of Salivary Hypofunction (MARSH): A pilot, first-in-human study of interferon gamma-stimulated marrow mesenchymal stromal cells for treatment of radiation-induced xerostomia. Cytotherapy. 2023 Nov;25(11):1139-1144. doi: 10.1016/j.jcyt.2023.07.009. Epub 2023 Aug 15.
Blitzer GC, Rogus-Pulia NM, Mattison RJ, Varghese T, Ganz O, Chappell R, Galipeau J, McDowell KA, Meyers RO, Glazer TA, Kimple RJ. Marrow-Derived Autologous Stromal Cells for the Restoration of Salivary Hypofunction (MARSH): Study protocol for a phase 1 dose-escalation trial of patients with xerostomia after radiation therapy for head and neck cancer: MARSH: Marrow-Derived Autologous Stromal Cells for the Restoration of Salivary Hypofunction. Cytotherapy. 2022 May;24(5):534-543. doi: 10.1016/j.jcyt.2021.11.003. Epub 2022 Feb 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	mesenchymal stem cells	Cell therapy	1e+07 cells	Other

Indications

No indication recorded.