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Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

Primary Purpose

Tracheal Stenosis, Laryngeal Stenosis

Status
Enrolling by invitation
Phase
Phase 2
Locations
Belarus
Study Type
Interventional
Intervention
Olfactory mucosa-derived mesenchymal stem cells
Patients treated according to current clinical protocols
Sponsored by
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tracheal Stenosis focused on measuring mesenchymal stem cells, Tracheal/Laryngeal Stenosis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-confirmed diagnosis of chronic laryngeal or tracheal stenosis;

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.

Sites / Locations

  • Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients with tracheal/laryngeal stenosis receiving standard treatment and stem cells

Patients with tracheal/laryngeal stenosis receiving standard treatment

Arm Description

Patients with tracheal/laryngeal stenosis receiving standard surgical treatment and mesenchymal stem cells

Patients with tracheal/laryngeal stenosis receiving standard surgical treatment

Outcomes

Primary Outcome Measures

Number of patients who didn't require the repeated surgical interventions
Relative number of patients who didn't require the repeated surgical interventions after MSC therapy

Secondary Outcome Measures

Full Information

First Posted
August 26, 2022
Last Updated
September 9, 2022
Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
The Republican Center for Research and Practice in Otolaryngology
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1. Study Identification

Unique Protocol Identification Number
NCT05535803
Brief Title
Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells
Official Title
Treatment of Laryngotracheal Stenosis Using Autologous Olfactory-mucosa-derived Mesenchymal Stem Cells
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
The Republican Center for Research and Practice in Otolaryngology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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 with/without cartilage defects 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tracheal Stenosis, Laryngeal Stenosis
Keywords
mesenchymal stem cells, Tracheal/Laryngeal Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with tracheal/laryngeal stenosis receiving standard treatment and stem cells
Arm Type
Experimental
Arm Description
Patients with tracheal/laryngeal stenosis receiving standard surgical treatment and mesenchymal stem cells
Arm Title
Patients with tracheal/laryngeal stenosis receiving standard treatment
Arm Type
Active Comparator
Arm Description
Patients with tracheal/laryngeal stenosis receiving standard surgical treatment
Intervention Type
Biological
Intervention Name(s)
Olfactory mucosa-derived mesenchymal stem cells
Intervention Description
Autologous olfactory mucosa-derived mesenchymal stem cells
Intervention Type
Other
Intervention Name(s)
Patients treated according to current clinical protocols
Intervention Description
Patients treated according to current clinical protocols
Primary Outcome Measure Information:
Title
Number of patients who didn't require the repeated surgical interventions
Description
Relative number of patients who didn't require the repeated surgical interventions after MSC therapy
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -confirmed diagnosis of chronic laryngeal or tracheal stenosis; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei Hancharou, Dr
Organizational Affiliation
Institute for biophysics and cellular engineering NAS of Belarus
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elvira Strinkevich, Dr
Organizational Affiliation
The Republican Center for Research and Practice in Otolaryngology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Valery Chekan, Dr
Organizational Affiliation
The Republican Center for Research and Practice in Otolaryngology
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
City
Minsk
ZIP/Postal Code
220072
Country
Belarus

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

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