Mesenchymal Stem Cells for Radiation-induced Xerostomia

NCT03876197 | Unknown Phase 1 DMC

• 2 other identifiers: CVB2019-12014-004349-29
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Xerostomia Due to Radiotherapy

Outcome Measures

Primary Outcomes (5)

• Safety: Serious Adverse Events (SAEs) and new chronic diseases

  SAEs according to the ICH-GCP definition and new chronic diseases. For patients not attending the planned hospital visit consider searching The National Patient Register will be searched for registered SAEs. Number of patients

  5 years from randomization

• Overall survival

  Overall survival is defined as the time from the intraglandular dose of the investigational product (MSCs or placebo) to the date of death or the date the subject is last known to be alive

  5 years from randomization

• Relapse of oropharyngeal cancer

  Number of participants with relapse will be reported

  5 years from randomization

• New malignancies

  Number of subjects who have new malignancies will be reported

  5 years from randomization

• Zoonotic Diseases

  Number of subjects diagnosed Zoonotic Diseases will be reported

  5 years from randomization

Secondary Outcomes (1)

• Patient-reported outcome measures-Health-related quality of life (HRQoL

  5 years from randomization

Study Arms (2)

Autologous Adipose-derived mesenchymal stem cells

EXPERIMENTAL

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

Biological: Autologous adipose-derived mesenchymal stem/stromal cells

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Autologous adipose-derived mesenchymal stem/stromal cells BIOLOGICAL

Autologous adipose-derived mesenchymal stem/stromal cells

Autologous Adipose-derived mesenchymal stem cells

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Subjects who were not enrolled in the MESRIX trial

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Otolaryngology, University Hospital of Copenhagen

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Radiation Injuries; Xerostomia; Long Term Adverse Effects

Condition Hierarchy (Ancestors)

Wounds and Injuries; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charlotte Lynggaard, MD

  Department of Otolaryngology, Rigshospitalet, Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Long-term follow-up of Randomized controlled trial MESRIX

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 15, 2019
• Study Start: August 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)