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Laryngo-Tracheal Tissue-Engineered Clinical Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Kuban State Medical University
Sponsor:
Information provided by (Responsible Party):
Kuban State Medical University
ClinicalTrials.gov Identifier:
NCT01997437
First received: November 5, 2013
Last updated: November 22, 2013
Last verified: November 2013
  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:
  • 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.


Estimated Enrollment: 1
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)
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:

  • Primary tracheal malignancies (the diseased tracheal extension is beyond standard resectability);
  • Tracheoesophageal fistula (the diseased trachea-esophageal defect is beyond standard resectability);
  • Tracheal stenosis (the diseased tracheal extension is beyond standard resectability);
  • Tracheobronchial malacia(primitive or secondary),(the diseased tracheal extension is beyond standard resectability or medical treatment - endoluminal stenting or dilations)

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

Contacts
Contact: Paolo Macchiarini, MD, PhD +46 760503213 paolo.macchiarini@ki.se

Locations
Russian Federation
Clinical Regional Hospital #1 Recruiting
Krasnodar, Russian Federation, 350029
Contact: Vladimir A. Porhanov, MD, PhD    007(861)257-58-84    giliv@list.ru   
Contact: Igor S. Polyakov, MD, PhD    007 928 2013313    i79282688844@gmail.com   
Sub-Investigator: Irina V. Gilevich, MD         
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:
No publications provided

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
Last Updated: November 22, 2013
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 September 22, 2014