Mesenchymal Stem Cells for Radiation-induced Xerostomia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2023-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mesenchymal Stemcells for Radiation Induced Xerostomia

NCT02513238

Xerostomia

COMPLETED PHASE2

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

NCT04776538

Xerostomia Following Radiotherapy

UNKNOWN PHASE2

Allogeneic Mesenchymal Stem Cells for Radiation-induced Hyposalivation and Xerostomia/Dry Mouth

NCT03874572

Xerostomia Due to Radiotherapy Hyposalivation Xerostomia +6 more

ACTIVE_NOT_RECRUITING PHASE1

Repeated Mesenchymal Stem Cell Therapy for Radiation-Induced Hyposalivation and Xerostomia in Head and Neck Cancer Survivors

NCT07290946

Xerostomia Due to Hyposecretion of Salivary Gland Xerostomia Due to Radiotherapy Sjögren´s Syndrome

NOT_YET_RECRUITING PHASE2

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

NCT04489732

Xerostomia Following Radiotherapy

ACTIVE_NOT_RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Long-term follow-up of Randomized controlled trial MESRIX

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Autologous Adipose-derived mesenchymal stem cells

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

Group Type EXPERIMENTAL

Autologous adipose-derived mesenchymal stem/stromal cells

Intervention Type BIOLOGICAL

Autologous adipose-derived mesenchymal stem/stromal cells

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Isotonic NaCl (0,9mg/ml) and human albumin (HA) 1%

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Autologous adipose-derived mesenchymal stem/stromal cells

Intervention Type BIOLOGICAL

Placebo

Isotonic NaCl (0,9mg/ml) and human albumin (HA) 1%

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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