This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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: January 25, 2016
Last verified: January 2016
Results First Received: January 3, 2014  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Stem-cell Seeded Bioartificial Trachea 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

Participant Flow:   Overall Study
    Stem-cell Seeded Bioartificial Trachea
STARTED   6 
COMPLETED   6 
NOT COMPLETED   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tissue-engineered Airway Transplantation

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


Baseline Measures
   Tissue-engineered Airway Transplantation 
Overall Participants Analyzed 
[Units: Participants]
 6 
Age 
[Units: Years]
Mean (Full Range)
 33 
 (28 to 41) 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   6 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   2 
Male   4 
Region of Enrollment 
[Units: Participants]
 
Russian Federation   5 
Jordan   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Safety of Stem-cell Seeded Bioartificial Tracheal Scaffold   [ Time Frame: 12 months post operative follow up ]

2.  Primary:   Number of Mononuclear Cells (MNCs) Per ml   [ Time Frame: 1 time before seeding on scaffold ]

3.  Secondary:   Number of Survival Patients   [ Time Frame: 12 months post operative follow up ]

4.  Secondary:   Number of Disease Free Survival Patients   [ Time Frame: 12 months post operative follow up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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
e-mail: pmacchiarini@ksma.ru


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: January 25, 2016