Trial Outcomes & Findings for Laryngo-Tracheal Tissue-Engineered Clinical Transplantation (NCT NCT01997437)

NCT ID: NCT01997437

Last Updated: 2016-03-07

Results Overview

Safety of the tissue engineered trachea measured by occurrence of adverse events throughout 12 months post operative follow up

• Recruitment status: UNKNOWN
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: 12 months post operative follow up
• Results posted on: 2016-03-07

Participant Flow

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.

Participant milestones

Measure	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
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Laryngo-Tracheal Tissue-Engineered Clinical Transplantation

Baseline characteristics by cohort

Measure	Tissue-engineered Airway Transplantation n=6 Participants 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
Age, Continuous	33 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment Russian Federation	5 participants n=5 Participants
Region of Enrollment Jordan	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Stem-cell Seeded Bioartificial Trachea n=6 Participants 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
Safety of Stem-cell Seeded Bioartificial Tracheal Scaffold	0 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Stem-cell Seeded Bioartificial Trachea n=6 Participants 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
Number of Mononuclear Cells (MNCs) Per ml	2773000 MNCs per ml Standard Error 353579

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Stem-cell Seeded Bioartificial Trachea n=6 Participants 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
Number of Survival Patients	6 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Stem-cell Seeded Bioartificial Trachea n=6 Participants 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
Number of Disease Free Survival Patients	6 participants

Adverse Events

Stem-cell Seeded Bioartificial Trachea

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Stem-cell Seeded Bioartificial Trachea n=6 participants at risk 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
Respiratory, thoracic and mediastinal disorders Granulation and Fistula	50.0% 3/6 • Number of events 3 • 3 year Adverse events are assessed by physiological parameters, bronchoscopy with bronchoscopic alveolar lavage, computer tomography

Other adverse events

Adverse event data not reported

Additional Information

Dr. Paolo Macchiarini

Kuban State Medical University

Phone: +7(928)-268-80-00

Email: pmacchiarini@ksma.ru

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place