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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

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

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.

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

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

Information from the National Library of Medicine

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

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Russian Federation
Clinical Regional Hospital #1
Krasnodar, Russian Federation, 350029
Sponsors and Collaborators
Kuban State Medical University
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Principal Investigator: Paolo Macchiarini, MD, PhD Kuban State Medical University
Additional Information:
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;

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Responsible Party: Kuban State Medical University
ClinicalTrials.gov Identifier: NCT01997437    
Other Study ID Numbers: 11.G34.31.0065
First Posted: November 28, 2013    Key Record Dates
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:
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Tracheal Diseases
Respiratory Tract Diseases