Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

June 5, 2019 updated by: Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology

Treatment of Laryngotracheal Stenosis Using Autologous Olfactory-mucosa-derived Mesenchymal Stem Cells

The trial evaluates the safety and efficacy of the olfactory mucosa-derived mesenchymal stem cells based therapy for the patients with chronic laryngeal and tracheal stenosis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Trial evaluating the safety and efficacy of olfactory mucosa-derived mesenchymal stem cells based therapy for the patients with chronic laryngeal and tracheal stenosis.

Mesenchymal stem cells are obtained from tissue biopsy of olfactory mucosa using explant method. Biomass of autologous mesenchymal stem cells in 10% human albumin solution is injected submucosally around and over the tissue after removal of a granuloma tissue during surgical intervention.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Minsk, Belarus, 220000
        • The Republican Center for Research and Practice in Otolaryngology
      • Minsk, Belarus, 220114
        • The Republican Research and Practical Center for Epidemiology and Microbiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • confirmed diagnosis of chronic laryngeal or tracheal stenosis;
  • absence of cartilage damage.

Exclusion Criteria:

  • refuse of patient to participate in the trial;
  • acute infectious diseases;
  • chronic mental disorders with severe manifestations;
  • pregnancy/lactation;
  • intercurrent severe chronic diseases;
  • HIV, Hepatites B/C;
  • active tuberculosis;
  • alcohol use disorder/drug addiction;
  • cachexia of any origin;
  • malignant neoplasms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mesenchymal stem cell treated group
Patients treated according to current clinical protocols plus autologous olfactory mucosa-derived mesenchymal stem cells
Biological: Olfactory mucosa-derived mesenchymal stem cells
Olfactory mucosa-derived mesenchymal stem cells
NO_INTERVENTION: Control group
Patients treated according to current clinical protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients who didn't require the repeated surgical interventions
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tracheostomy decannulation
Time Frame: 6 month
Removal of the tracheostomy tube after the treatment.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Republican Research and Practical Center for Epidemiology and Microbiology

Collaborators

The Republican Center for Research and Practice in Otolaryngology
Belarusian Medical Academy of Post-Graduate Education

Investigators

  • Principal Investigator: Andrei Y Hancharou, Dr, Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology
  • Study Chair: Valery L Chekan, Dr, Associate Professor of the Belarusian Medical Academy of Post-Graduate Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 3, 2017

Primary Completion (ACTUAL)

January 4, 2019

Study Completion (ACTUAL)

May 20, 2019

Study Registration Dates

First Submitted

April 12, 2017

First Submitted That Met QC Criteria

April 22, 2017

First Posted (ACTUAL)

April 26, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRPCEM_MSC1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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