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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tracheal Diseases
Intervention Device: Stem-cell seeded bioartificial tracheal scaffold
Enrollment 6

Recruitment Details The dates of the recruitment period are from June 2012 to January 2014. The recruitment process have been done in medical clinic: Krasnodar Regional Hospital #1.
Pre-assignment Details  
Arm/Group Title Stem-cell Seeded Bioartificial Trachea
Hide Arm/Group Description 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
Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Tissue-engineered Airway Transplantation
Hide Arm/Group Description

Stem-cell seeded bioartificial tracheal scaffold

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

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants
33
(28 to 41)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
2
  33.3%
Male
4
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants
Russian Federation 5
Jordan 1
1.Primary Outcome
Title Safety of Stem-cell Seeded Bioartificial Tracheal Scaffold
Hide Description Safety of the tissue engineered trachea measured by occurrence of adverse events throughout 12 months post operative follow up
Time Frame 12 months post operative follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stem-cell Seeded Bioartificial Trachea
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
0
2.Primary Outcome
Title Number of Mononuclear Cells (MNCs) Per ml
Hide Description MNCs were isolated from bone marrow fom each patient, and were counted by flow cytometry method. MNC were used for seeding on scaffold.
Time Frame 1 time before seeding on scaffold
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stem-cell Seeded Bioartificial Trachea
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 6
Mean (Standard Error)
Unit of Measure: MNCs per ml
2773000  (353579)
3.Secondary Outcome
Title Number of Survival Patients
Hide Description To evaluate the survival of patient after transplantation of stem-cell seeded bioartificial trachea during 12 months post operative follow up.
Time Frame 12 months post operative follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stem-cell Seeded Bioartificial Trachea
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
6
4.Secondary Outcome
Title Number of Disease Free Survival Patients
Hide Description The disease free survival of patient were evaluated after transplantation of stem-cell seeded bioartificial trachea during 12 months post operative follow up.
Time Frame 12 months post operative follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stem-cell Seeded Bioartificial Trachea
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
6
Time Frame 3 year
Adverse Event Reporting Description Adverse events are assessed by physiological parameters, bronchoscopy with bronchoscopic alveolar lavage, computer tomography
 
Arm/Group Title Stem-cell Seeded Bioartificial Trachea
Hide Arm/Group Description 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
All-Cause Mortality
Stem-cell Seeded Bioartificial Trachea
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Stem-cell Seeded Bioartificial Trachea
Affected / at Risk (%) # Events
Total   3/6 (50.00%)    
Respiratory, thoracic and mediastinal disorders   
Granulation and Fistula  [1]  3/6 (50.00%)  3
Indicates events were collected by systematic assessment
[1]
Granulation or fistula resulted in 2 patient into re-transplantation, in 1 patient in explantation and tracheostoma
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stem-cell Seeded Bioartificial Trachea
Affected / at Risk (%) # Events
Total   0/6 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Paolo Macchiarini
Organization: Kuban State Medical University
Phone: +7(928)-268-80-00
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 Submitted: November 5, 2013
First Posted: November 28, 2013
Results First Submitted: January 3, 2014
Results First Posted: May 22, 2015
Last Update Posted: March 7, 2016