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Laryngo-Tracheal Tissue-Engineered Clinical Transplantation

NCT01997437 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2016-03-07

Study results available
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Summary

The proposed protocol will involve the replacement of the trachea using a synthetic bioengineered scaffold seeded with autologous mononuclear cells as an intraoperative solution for patients with with benign and malignant laryngo-tracheal diseases or other terminal conditions of the trachea.

Tracheal transplant is indicated as the only therapeutic alternative in cases where instrumental, endoscopic and other evaluations show that the length of residual healthy airways (about 6 cm or longer than 50% of the airway length) and the localization and extension of the obstruction make it impossible to perform a surgical resection of the pathological segment.

In addition to tracheal surgical transplant techniques, this protocol requires knowledge and experience with autologous cell preparation as well as scaffold seeding procedures.

Conditions

  • Tracheal Diseases

Interventions

DEVICE

Stem-cell seeded bioartificial tracheal scaffold

Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ

Sponsors & Collaborators

  • Kuban State Medical University

    lead OTHER

Principal Investigators

  • Paolo Macchiarini, MD, PhD · Kuban State Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-09-30
Completion
2016-12-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01997437 on ClinicalTrials.gov