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

NCT03874572 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-01-29

No results posted yet for this study

Summary

An investigator-initiated, non-randomized, open label study to investigate the safety, feasibility and tolerability of intraglandular injection of allogeneic mesenchymal stem/stromal cells (MSCs) into the submandibular and parotid glands of the patients with radiation-induced hyposalivation and xerostomia after radiation for a oropharyngeal squamous cell carcinoma

Conditions

  • Xerostomia Due to Radiotherapy
  • Hyposalivation
  • Xerostomia
  • Oropharynx Cancer
  • Salivary Gland Diseases
  • Dry Mouth
  • Mesenchymal Stem Cells
  • Mesenchymal Stromal Cells
  • Stem Cells

Interventions

BIOLOGICAL

Allogeneic adipose derived stem/stromal cells

Culture expanded allogeneic adipose derived stem/stromal cells

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Charlotte Lynggaard, MD · Department of Otolaryngology, Rigshospitalet, University Hospital of Copenhagen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-18
Primary Completion
2020-06-22
Completion
2025-12-01

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 NCT03874572 on ClinicalTrials.gov