Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells

NCT ID: NCT03130374

Last Updated: 2019-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-03

Study Completion Date

2019-05-20

Brief Summary

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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

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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.

Conditions

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Tracheal Stenosis Laryngeal Stenosis Mesenchymal Stem Cells

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mesenchymal stem cell treated group

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

Group Type EXPERIMENTAL

Olfactory mucosa-derived mesenchymal stem cells

Intervention Type BIOLOGICAL

Olfactory mucosa-derived mesenchymal stem cells

Control group

Patients treated according to current clinical protocols

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Olfactory mucosa-derived mesenchymal stem cells

Olfactory mucosa-derived mesenchymal stem cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belarusian Medical Academy of Post-Graduate Education

OTHER

Sponsor Role collaborator

The Republican Center for Research and Practice in Otolaryngology

UNKNOWN

Sponsor Role collaborator

The Republican Research and Practical Center for Epidemiology and Microbiology

OTHER

Sponsor Role lead

Responsible Party

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Andrei Y. Hancharou

Head of the Laboratory for Immunology and Cellular Biotechnology,

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrei Y Hancharou, Dr

Role: PRINCIPAL_INVESTIGATOR

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

Valery L Chekan, Dr

Role: STUDY_CHAIR

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

Locations

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The Republican Center for Research and Practice in Otolaryngology

Minsk, , Belarus

Site Status

The Republican Research and Practical Center for Epidemiology and Microbiology

Minsk, , Belarus

Site Status

Countries

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Belarus

Other Identifiers

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RRPCEM_MSC1

Identifier Type: -

Identifier Source: org_study_id

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