Safety and Efficacy of Mesenchymal Stem Cell for Radiation-induced Hyposalivation and Xerostomia in Previous Head and Neck Cancer Patients

Summary

The incidence of head and neck cancer is increasing in the Western World, including Denmark. Cancer of the head and neck and its treatment often have a detrimental and lifelong impact on the quality of life of the patients. Radiotherapy is a key component for approximately 80% of all patients with head and neck cancer and despite the enormous improvement in ionizing radiotherapy, the radiation still leads to significant ionizing of healthy tissue, including the radiation-sensitive salivary glands. Salivary glands suffer severe damage from radiation, and as these cells are the principal sites of fluid secretion one of the most prevalent side effect of irradiation for head and neck cancer is hyposalivation and dry mouth syndrome, xerostomia. Xerostomia leads to debilitating oral disorders and major implication for the overall quality of life, including social life and professional life. Currently, only symptomatic treatment is available to patients suffering from xerostomia, and therefore there is an immense, unmet need for new treatment strategies for hyposalivation and xerostomia.

Stem cells have been identified as a potential treatment modality for a wide variety of disorders by their ability to differentiate into many functional cell types, and stem cells have been suggested as an approach to restoring the function of salivary glands after radiotherapy damage.

The purpose of the study is to assess the efficacy and safety of the injection of stem cells from healthy donors on radiation-induced salivary gland hypofunction and xerostomia in previous head and neck cancer patients. The project can potentially help to develop a clinically relevant treatment option for the growing number of patients suffering from xerostomia after irradiation. The development of new therapies is especially meaningful since only sub-optimal, symptomatic treatments are currently available, and since the symptom of xerostomia immensely reduces quality of life.

Conditions

• Xerostomia Following Radiotherapy

Interventions

BIOLOGICAL

Stem cells

Each participant will be double-blindly randomized to receive either adipose-derived allogeneic stem cells or placebo consisting of CryoStor10 (BiolifeSolutions), the freeze media for ASCs containing 10% Dimethyl sulfoxide (DMSO).

BIOLOGICAL

Placebo

Each participant will be double-blindly randomized to receive either adipose-derived allogeneic stem cells or placebo consisting of CryoStor10 (BiolifeSolutions), the freeze media for ASCs containing 10% Dimethyl sulfoxide (DMSO).

Sponsors & Collaborators

• Cardiology Stem Cell Centre, The Heart Centre, Rigshospitalet

  collaborator UNKNOWN

• The Cell Therapy Facility, The Blood bank, Dept. of Clinical Immunology, 2034, Rigshospitalet, Denmark

  collaborator UNKNOWN

• Department of Oncology, 3994, Rigshospitalet, Denmark

  collaborator UNKNOWN

• Department of Oncology Herlev Hospital, Denmark

  collaborator UNKNOWN

• Department of Dentistry and Oral Health, Aarhus, Denmark

  collaborator UNKNOWN

• Rigshospitalet, Denmark

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-09

Primary Completion

2024-03-01

Completion

2024-03-01

Countries

• Denmark

Study Locations