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|
- Patients With Benign and Malignant Laryngo-Tracheal Diseases [ Time Frame: Within first 30 days after surgery ] [ Designated as safety issue: Yes ]A tissue engineered tracheobronchial transplant using a bioengineered nanocomposite and autologous mononuclear cells may represent the only curative chance for terminal patients. Peripheral blood mononuclear cells are able to stimulate the migration of peripheral blood stem cells to transplanted laryngo-tracheal segments and to cause their differentiation into both respiratory epithelium and cartilaginous cells.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (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
|Contact: Paolo Macchiarini, MD, PhD||+46 firstname.lastname@example.org|
|Clinical Regional Hospital #1||Recruiting|
|Krasnodar, Russian Federation, 350029|
|Contact: Vladimir A. Porhanov, MD, PhD 007(861)257-58-84 email@example.com|
|Contact: Igor S. Polyakov, MD, PhD 007 928 2013313 firstname.lastname@example.org|
|Sub-Investigator: Irina V. Gilevich, MD|
|Principal Investigator:||Paolo Macchiarini, MD, PhD||Advanced Center of Translational Regenerative Medicine, Karolinska Institute, Stockholm, Sweden|