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Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03130374
First Posted: April 26, 2017
Last Update Posted: April 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Belarusian Medical Academy of Post-Graduate Education
The Republican Center for Research and Practice in Otolaryngology
Information provided by (Responsible Party):
Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology
  Purpose
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

Condition Intervention Phase
Tracheal Stenosis Laryngeal Stenosis Mesenchymal Stem Cells Biological: Olfactory mucosa-derived mesenchymal stem cells Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Laryngotracheal Stenosis Using Autologous Olfactory-mucosa-derived Mesenchymal Stem Cells

Further study details as provided by Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology:

Primary Outcome Measures:
  • Number of patients who didn't require the repeated surgical interventions [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Tracheostomy decannulation [ Time Frame: 6 month ]
    Removal of the tracheostomy tube after the treatment.


Estimated Enrollment: 12
Actual Study Start Date: January 3, 2017
Estimated Study Completion Date: December 31, 2019
Estimated Primary Completion Date: June 30, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130374


Sponsors and Collaborators
The Republican Research and Practical Center for Epidemiology and Microbiology
Belarusian Medical Academy of Post-Graduate Education
The Republican Center for Research and Practice in Otolaryngology
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
  More Information

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site

Responsible Party: Andrei Y. Hancharou, Head of the Laboratory for Immunology and Cellular Biotechnology,, The Republican Research and Practical Center for Epidemiology and Microbiology
ClinicalTrials.gov Identifier: NCT03130374     History of Changes
Other Study ID Numbers: RRPCEM_MSC1
First Submitted: April 12, 2017
First Posted: April 26, 2017
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology:
mesenchymal stem cells
Tracheal Stenosis
Laryngeal Stenosis
cell therapy

Additional relevant MeSH terms:
Constriction, Pathologic
Tracheal Stenosis
Laryngostenosis
Pathological Conditions, Anatomical
Tracheal Diseases
Respiratory Tract Diseases
Laryngeal Diseases
Otorhinolaryngologic Diseases
Respiratory System Abnormalities
Congenital Abnormalities