Laryngo-Tracheal Tissue-Engineered Clinical Transplantation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kuban State Medical University
ClinicalTrials.gov Identifier:
NCT01997437
First received: November 5, 2013
Last updated: May 18, 2015
Last verified: May 2015
  Purpose

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 Intervention
Tracheal Diseases
Device: Stem-cell seeded bioartificial tracheal scaffold

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Kuban State Medical University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 6
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01997437

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 Advanced Center of Translational Regenerative Medicine, Karolinska Institute, Stockholm, Sweden
  More Information

Additional Information:
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
Study First Received: November 5, 2013
Results First Received: January 3, 2014
Last Updated: May 18, 2015
Health Authority: Russia: The Ministry of Education and Science of the Russian Federation
Russia: Ministry of Health of the Russian Federation
Russia: Ethics Committee

Keywords provided by Kuban State Medical University:
Tissue-engineered tracheal transplantation

Additional relevant MeSH terms:
Tracheal Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 29, 2015