NCT03130374

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

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2017

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

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

January 3, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2019

Completed
Last Updated

June 7, 2019

Status Verified

June 1, 2019

Enrollment Period

2 years

First QC Date

April 12, 2017

Last Update Submit

June 5, 2019

Conditions

Tracheal StenosisLaryngeal StenosisMesenchymal Stem Cells

Keywords

mesenchymal stem cellsTracheal StenosisLaryngeal Stenosiscell therapy

Outcome Measures

Primary Outcomes (1)

  • Number of patients who didn't require the repeated surgical interventions

    1 year

Secondary Outcomes (1)

  • Tracheostomy decannulation

    6 month

Study Arms (2)

Mesenchymal stem cell treated group

EXPERIMENTAL

Patients treated according to current clinical protocols plus autologous olfactory mucosa-derived mesenchymal stem cells

Biological: Olfactory mucosa-derived mesenchymal stem cells

Control group

NO INTERVENTION

Patients treated according to current clinical protocols

Interventions

Olfactory mucosa-derived mesenchymal stem cellsBIOLOGICAL

Olfactory mucosa-derived mesenchymal stem cells

Mesenchymal stem cell treated group

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;
  • absence of cartilage damage.

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 (2)

The Republican Center for Research and Practice in Otolaryngology

Minsk, 220000, Belarus

Location

The Republican Research and Practical Center for Epidemiology and Microbiology

Minsk, 220114, 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 Y Hancharou, Dr

    Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology

    PRINCIPAL INVESTIGATOR

  • Valery L Chekan, Dr

    Associate Professor of the Belarusian Medical Academy of Post-Graduate Education

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Laboratory for Immunology and Cellular Biotechnology,

Study Record Dates

First Submitted

April 12, 2017

First Posted

April 26, 2017

Study Start

January 3, 2017

Primary Completion

January 4, 2019

Study Completion

May 20, 2019

Last Updated

June 7, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)