Trial | NCT03130374  Report issue

Title

Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells
Treatment of Laryngotracheal Stenosis Using Autologous Olfactory-mucosa-derived Mesenchymal Stem Cells

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    12
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 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.
Study Started
Jan 03
2017
Primary Completion
Jan 04
2019
Study Completion
May 20
2019
Last Update
Jun 07
2019

Biological Olfactory mucosa-derived mesenchymal stem cells

Olfactory mucosa-derived mesenchymal stem cells

Mesenchymal stem cell treated group Experimental

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

Control group No Intervention

Patients treated according to current clinical protocols

Criteria 

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.
No Results Posted