NCT05535803

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 10, 2022

Status Verified

September 1, 2022

Enrollment Period

2.1 years

First QC Date

August 26, 2022

Last Update Submit

September 9, 2022

Conditions

Tracheal StenosisLaryngeal Stenosis

Keywords

mesenchymal stem cellsTracheal/Laryngeal Stenosis

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Study Arms (2)

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

EXPERIMENTAL

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

Biological: Olfactory mucosa-derived mesenchymal stem cellsOther: Patients treated according to current clinical protocols

Patients with tracheal/laryngeal stenosis receiving standard treatment

ACTIVE COMPARATOR

Patients with tracheal/laryngeal stenosis receiving standard surgical treatment

Other: Patients treated according to current clinical protocols

Interventions

Olfactory mucosa-derived mesenchymal stem cellsBIOLOGICAL

Autologous olfactory mucosa-derived mesenchymal stem cells

Patients with tracheal/laryngeal stenosis receiving standard treatment and stem cells
Patients treated according to current clinical protocolsOTHER

Patients treated according to current clinical protocols

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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • confirmed diagnosis of chronic laryngeal or tracheal stenosis;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Minsk, 220072, Belarus

Location

MeSH Terms

Conditions

Tracheal StenosisLaryngostenosis

Condition Hierarchy (Ancestors)

Tracheal DiseasesRespiratory Tract DiseasesLaryngeal DiseasesOtorhinolaryngologic DiseasesRespiratory System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Andrei Hancharou, Dr

    Institute for biophysics and cellular engineering NAS of Belarus

    STUDY DIRECTOR

  • Elvira Strinkevich, Dr

    The Republican Center for Research and Practice in Otolaryngology

    STUDY DIRECTOR

  • Valery Chekan, Dr

    The Republican Center for Research and Practice in Otolaryngology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2022

First Posted

September 10, 2022

Study Start

June 1, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

September 10, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)