Mesenchymal Stem Cells for Radiation-induced Xerostomia

Rigshospitalet

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Long Term Adverse Effects; Mesenchymal Stromal Cells; Radiation Toxicity; Hyposalivation; Mesenchymal Stem Cells; Dry Mouth; Xerostomia Due to Radiotherapy

Treatments: Biological: Autologous adipose-derived mesenchymal stem/stromal cells; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03876197

2014-004349-29 (EudraCT Number)

CVB2019-1

Details and patient eligibility

About

A prospective study for long-term follow-up (LTFU) to evaluate safety and efficacy in subjects who participated in the Phase 1/2 randomized placebo-controlled trial MESRIX.

Full description

This is a LTFU study to assess the long-term and late effects of treatment with MSCs or placebo given ultrasound-guided into the submandibular glands in subjects participating in the MESRIX trial. Study participants from the MESRIX trial will be invited for a clinical visit. The visit will include medical history, an ENT examination; measurements of the saliva production by sialometry, a Magnetic resonance imaging scan (MRI) and obtaining data on the patient-reported outcome with Xerostomia Questionnaire (XQ) and Visual-Analogue-Symptomatic scale (VAS). Subjects, who are not able or willing to attend a clinical visit, will be encouraged to fill out the Questionnaires online or on paper. If a study participant has deceased, information of the cause of death will be investigated in The Danish Register of Causes of Death

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Assessment of safety and treatment efficacy in subjects who were enrolled in the MESRIX Phase I/II clinical trial
2. Subjects who were treated with either autologous mesenchymal stem cells or placebo
3. Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the trial

Exclusion criteria

1. Subjects who were not enrolled in the MESRIX trial

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Autologous Adipose-derived mesenchymal stem cells

Experimental group

Description:

Autologous adipose-derived mesenchymal stem cells transplanted intraglandular in patients with radiation-induced hyposalivation and xerostomia

Treatment:

Biological: Autologous adipose-derived mesenchymal stem/stromal cells

Placebo

Placebo Comparator group

Description:

2 ml placebo: Isotonic NaCl (0.9mg(ml) and human albumin (HA) 1%

Treatment:

Other: Placebo