Laryngo-Tracheal Tissue-Engineered Clinical Transplantation
Clinical Trial Evaluation of Stem-cell Based Bioartificial Airway Transplantation for Patients With Benign and Malignant Laryngo-tracheal Diseases
1 other identifier
interventional
6
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2013
CompletedFirst Posted
Study publicly available on registry
November 28, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedResults Posted
Study results publicly available
May 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 7, 2016
January 1, 2016
2.8 years
November 5, 2013
January 3, 2014
January 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety of Stem-cell Seeded Bioartificial Tracheal Scaffold
Safety of the tissue engineered trachea measured by occurrence of adverse events throughout 12 months post operative follow up
12 months post operative follow up
Number of Mononuclear Cells (MNCs) Per ml
MNCs were isolated from bone marrow fom each patient, and were counted by flow cytometry method. MNC were used for seeding on scaffold.
1 time before seeding on scaffold
Secondary Outcomes (2)
Number of Survival Patients
12 months post operative follow up
Number of Disease Free Survival Patients
12 months post operative follow up
Study Arms (1)
Tissue-engineered airway transplantation
OTHERStem-cell seeded bioartificial tracheal scaffold
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Presence of systemic metastatic lesions and positive mediastinal lymph nodes (malignancies);
- Routine functional and psychological contraindication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Regional Hospital #1
Krasnodar, 350029, Russia
Related Publications (1)
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;
BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Paolo Macchiarini
- Organization
- Kuban State Medical University
Study Officials
- PRINCIPAL INVESTIGATOR
Paolo Macchiarini, MD, PhD
Kuban State Medical University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2013
First Posted
November 28, 2013
Study Start
December 1, 2013
Primary Completion
September 1, 2016
Study Completion
December 1, 2016
Last Updated
March 7, 2016
Results First Posted
May 22, 2015
Record last verified: 2016-01