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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03130374
Other study ID # RRPCEM_MSC1
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date January 3, 2017
Est. completion date May 20, 2019

Study information

Verified date June 2019
Source The Republican Research and Practical Center for Epidemiology and Microbiology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date May 20, 2019
Est. primary completion date January 4, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design


Intervention

Biological:
Olfactory mucosa-derived mesenchymal stem cells
Olfactory mucosa-derived mesenchymal stem cells

Locations

Country Name City State
Belarus The Republican Center for Research and Practice in Otolaryngology Minsk
Belarus The Republican Research and Practical Center for Epidemiology and Microbiology Minsk

Sponsors (3)

Lead Sponsor Collaborator
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

Country where clinical trial is conducted

Belarus, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients who didn't require the repeated surgical interventions 1 year
Secondary Tracheostomy decannulation Removal of the tracheostomy tube after the treatment. 6 month
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