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Mesenchymal Stem Cells for Radiation-induced Xerostomia

NCT03876197 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-10-22

No results posted yet for this study

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

Interventions

BIOLOGICAL

Autologous adipose-derived mesenchymal stem/stromal cells

Autologous adipose-derived mesenchymal stem/stromal cells

OTHER

Placebo

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

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Charlotte Lynggaard, MD · Department of Otolaryngology, Rigshospitalet, Copenhagen, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2022-12-01
Completion
2023-12-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03876197 on ClinicalTrials.gov