Laryngo-Tracheal Tissue-Engineered Clinical Transplantation
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinical Trial Evaluation of Stem-cell Based Bioartificial Airway Transplantation for Patients With Benign and Malignant Laryngo-tracheal Diseases|
- Safety of Stem-cell Seeded Bioartificial Tracheal Scaffold [ Time Frame: 12 months post operative follow up ] [ Designated as safety issue: Yes ]Safety of the tissue engineered trachea measured by occurrence of adverse events throughout 12 months post operative follow up
- Number of Mononuclear Cells (MNCs) Per ml [ Time Frame: 1 time before seeding on scaffold ] [ Designated as safety issue: Yes ]MNCs were isolated from bone marrow fom each patient, and were counted by flow cytometry method. MNC were used for seeding on scaffold.
- Number of Survival Patients [ Time Frame: 12 months post operative follow up ] [ Designated as safety issue: Yes ]To evaluate the survival of patient after transplantation of stem-cell seeded bioartificial trachea during 12 months post operative follow up.
- Number of Disease Free Survival Patients [ Time Frame: 12 months post operative follow up ] [ Designated as safety issue: Yes ]The disease free survival of patient were evaluated after transplantation of stem-cell seeded bioartificial trachea during 12 months post operative follow up.
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Tissue-engineered airway transplantation
Stem-cell seeded bioartificial tracheal scaffold
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01997437
|Clinical Regional Hospital #1|
|Krasnodar, Russian Federation, 350029|
|Principal Investigator:||Paolo Macchiarini, MD, PhD||Kuban State Medical University|