Laryngo-Tracheal Tissue-Engineered Clinical Transplantation

• Sponsor: Kuban State Medical University
• Information provided by (Responsible Party): Kuban State Medical University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Tracheal Diseases	Device: Stem-cell seeded bioartificial tracheal scaffold	Not Applicable

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Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: December 2013
• Estimated Primary Completion Date: September 2016
• Estimated Study Completion Date: December 2016

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Extended (> 60% total length) benign and malignant diseases
• Already maximally pretreated patients
• No absolute surgical contraindications
• No regional and/or micro-metastasis (BMB proven)
• Normal psychological or psychiatric habitus
• IRB, Ethics and National Transplant clearance
• Written informed consent

Exclusion Criteria:

• Presence of systemic metastatic lesions and positive mediastinal lymph nodes (malignancies);
• Routine functional and psychological contraindication

Contacts and Locations

Locations

Russian Federation

Clinical Regional Hospital #1

Krasnodar, Russian Federation, 350029

Sponsors and Collaborators

Kuban State Medical University

Investigators

• Principal Investigator: Paolo Macchiarini, MD, PhD; Kuban State Medical University

More Information

Additional Information:

Regeneration of airways and lung. The official website of the project "Investigating the molecular mechanisms and underlying pathways of regenerative medicine approaches the tissue-engineering and cell therapy of airways and lungs" 

Publications:

Jungebluth, P, Alici, E, Baiguera S, et al. Tracheobronchial transplantation with a stem-cell-seeded bioartificial nanocomposite: a proof-of-concept study. Lancet 2011 Dec 10; 378 (9808):1997-2004; Macchiarini P, Jungebluth P, Go T, et al. Clinical transplantation of a tissue-engineered airway. Lancet 2008; 372, 2023-3030; Acocella F, Brizzola S, et al. Prefabricated tracheal prosthesis with partial biodegradable materials: a surgical and tissue engineering evaluation in vivo. Journal of Biomaterials Science; Polymer Edition 2007; 18(5):579-594; Bader A, Macchiarini P. Moving towards in situ tracheal regeneration: the bionic tissue engineered transplantation approach. J Cell Mol Med 2010; 14(7):1877-89; Jungebluth P, Moll G, Baiguera S, Macchiarini P. Tissue engineered airway: a regenerative solution. Clin Pharm Ther 2012; 91:81-93;

• Responsible Party: Kuban State Medical University
• ClinicalTrials.gov Identifier: NCT01997437 History of Changes
• Other Study ID Numbers: 11.G34.31.0065
• First Posted: November 28, 2013
• Results First Posted: May 22, 2015
• Last Update Posted: March 7, 2016
• Last Verified: January 2016

Keywords provided by Kuban State Medical University:

Tissue-engineered tracheal transplantation

Additional relevant MeSH terms:

Tracheal Diseases; Respiratory Tract Diseases