Laryngo-Tracheal Tissue-Engineered Clinical Transplantation
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|ClinicalTrials.gov Identifier: NCT01997437|
Recruitment Status : Unknown
Verified January 2016 by Kuban State Medical University.
Recruitment status was: Active, not recruiting
First Posted : November 28, 2013
Results First Posted : May 22, 2015
Last Update Posted : March 7, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Tracheal Diseases||Device: Stem-cell seeded bioartificial tracheal scaffold||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial Evaluation of Stem-cell Based Bioartificial Airway Transplantation for Patients With Benign and Malignant Laryngo-tracheal Diseases|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||December 2016|
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
- Safety of Stem-cell Seeded Bioartificial Tracheal Scaffold [ Time Frame: 12 months post operative follow up ]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 ]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 ]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 ]The disease free survival of patient were evaluated after transplantation of stem-cell seeded bioartificial trachea during 12 months post operative follow up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997437
|Clinical Regional Hospital #1|
|Krasnodar, Russian Federation, 350029|
|Principal Investigator:||Paolo Macchiarini, MD, PhD||Kuban State Medical University|