Thyroid CancerPhase 1/2NCT06051747
Patient-Customized Bioprinting Technology for Practical Regeneration of the Respiratory Tract (Trachea)
A Phase 1/2 study testing Three-dimensional patient-specific bioprinting trachea implantation in people with Thyroid Cancer, run by Ja Seong Bae, MD, phD at 1 site in South Korea.
Trial summary
This clinical trial aims to assess the effectiveness and safety of a novel approach utilizing biopolymers, hydrogels, mucous membranes, and cartilage tissue regeneration cells integrated into 3D bioprinting technology for the creation and implantation of patient-specific tracheal organs. Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Three-dimensional patient-specific bioprinting trachea implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jul 2023to 16 Aug 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age Range:
- Individuals between 19 and 75 years of age are eligible for participation.
- Specific Medical Condition:
- Patients must meet the following criteria and have thyroid or airway diseases necessitating partial or segmental resection:
- Thyroid Cancer Patients:
- For patients with thyroid cancer, inclusion is based on TNM staging, specifically stage II or higher differentiated thyroid cancer patients. Verification of complete removal through a freeze section test during surgery in accordance with the staging system for papillary carcinoma of the trachea is essential (Hum Pathol. 1993 Aug; 24(8):866-70).
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- Patients for whom conventional reconstruction methods, including single-stage anastomosis, are infeasible and require alternative approaches like flap reconstruction.
- Patients suitable for single anastomosis, but assessed to derive more benefits than risks from 3D bioprinting, considering factors such as post-surgery aftereffects, complications, prolonged recovery, and potential decline in quality of life due to surgical intervention.
- Defect Size Patients with defects encompassing more than 30% of the cartilage around the affected organ are eligible. Smaller defects may also qualify if reinforcing defects using soft tissue is infeasible due to factors such as surrounding inflammation, tissue instability, tissue adhesion, unstable blood supply, or the anticipation of reoperation during reconstruction.
- Pregnancy Consideration:
- In the case of childbearing women, individuals must provide a negative result on a pregnancy test and commit to using contraception throughout the clinical study period.
- Informed Consent:
- Participants must voluntarily provide written consent after receiving a comprehensive explanation of the clinical study.
Who cannot join
- Pregnancy and Lactation:
- Pregnant or lactating women are excluded from participation in the study.
- Prior Thyroid or Airway Surgery:
- Individuals who have undergone thyroid or airway peripheral surgery before undergoing screening are ineligible for participation.
- Persistent Inflammation:
- Patients with ongoing inflammation of the thyroid or surrounding tissues at the time of screening are excluded.
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- Systemic Inflammatory Disease:
- Patients diagnosed with systemic inflammatory diseases at the screening stage are not eligible to participate.
- Anesthesia Risk Factors:
- Individuals with a high risk of complications associated with general anesthesia due to existing liver disease, kidney disease, or heart disease are excluded.
- Sepsis:
- Patients diagnosed with sepsis at the time of screening are not eligible for participation.
- Hemorrhage Predisposition:
- Individuals with a predisposition to hemorrhage at the time of screening are excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of the Practical Usage Based Technology Using the Patient Customized Bioprinting Trachea for the Regeneration of Respiratory Tract (Trachea)
This clinical trial aims to assess the effectiveness and safety of a novel approach utilizing biopolymers, hydrogels, mucous membranes, and cartilage tissue regeneration cells integrated into 3D bioprinting technology for the creation and implantation of patient-specific tracheal organs.
Read the detailed description
Study Objective:
This clinical study focuses on patients with thyroid or airway diseases necessitating partial or segmental organ resection. The objective is to evaluate the feasibility, efficacy, and safety of transplanting functional patient-specific bioprinted tracheal organs as an innovative regenerative approach.
Patient Enrollment:
Patients voluntarily participate and provide written consent. A thorough screening procedure is conducted to determine their eligibility based on selection and exclusion criteria.
Bioprinting Process:
The study employs cutting-edge bioprinting technology to create complex organ tissues. Specifically, 3D cell printing is employed to fabricate a bioprinted tracheal organ. Stem cells derived from the human nasal cavity and nasal septum cartilage cells are integrated to form a cell-supporting body.
Transplantation Procedure:
Eligible patients receive transplantation of the functional patient-specific bioprinted trachea. The transplantation aims to restore tracheal functionality and address the unique challenges posed by thyroid and airway diseases.
Evaluation and Monitoring:
Following transplantation, a comprehensive assessment regimen is undertaken to evaluate both the effectiveness and safety of the procedure. This includes flexural laryngeal endoscopy, bronchoscopy, computed tomography (CT) scans, and laboratory tests.
Post-Transplant Measures:
To ensure the stability of the transplanted organ immediately after the procedure, neck fixing splints are employed to limit movement.
Thyroid Cancer Patients:
For patients diagnosed with thyroid cancer, a distinct follow-up protocol is established. A five-year observation period is implemented, extending beyond the standard follow-up for general cancer patients. Additional observations include thyroid ultrasound, Free T4, Thyroid-Stimulating Hormone (TSH), Thyroglobulin Antigen (Thyroglobulin Ag), and Anti-Thyroglobulin Antibody (Anti-TG Ab) tests conducted at the designated observation points.
This study seeks to contribute novel insights into the realm of regenerative medicine and enhance the understanding of patient-specific bioprinting technology as a potential solution for tracheal and airway diseases.
- Conditions
- Thyroid Cancer
- Being tested
- Three-dimensional patient-specific bioprinting trachea implantation
- Keywords
- Trachea
- Medical subject headings
- Thyroid Neoplasms, Tracheal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-dimensional patient-specific bioprinting trachea implantationProcedure or surgery
The intervention entails the creation of a 3D cell-printed tracheal organ, achieved through the fusion of biopolymer materials and the bioprinting (3D cell printing) technique. This process involves distribution of nasal cavity stem cells (hNTSCs) and nasal septum cartilage cells (hNCs) within hydrogel matrices, culminating in the formation of a personalized tracheal structure.
| Study group | Role | What they receive |
|---|---|---|
| Treated | Experimental | Three-dimensional patient-specific bioprinting trachea implantation Receives: Procedure: Three-dimensional patient-specific bioprinting trachea implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
airway lumen opening rate
measured by curved laryngeal endoscopy
Measured: 1 week, 2 weeks, 4 weeks, 24 weeks, 2 years
crust formation degree
measured by curved laryngeal endoscopy
Measured: 1 week, 2 weeks, 4 weeks, 24 weeks, 2 years
granuloma formation degree
measured by curved laryngeal endoscopy
Measured: 1 week, 2 weeks, 4 weeks, 24 weeks, 2 years
degree of inflammation
measured by curved laryngeal endoscopy
Measured: 1 week, 2 weeks, 4 weeks, 24 weeks, 2 years
other relevant findings
measured by curved laryngeal endoscopy
Measured: 1 week, 2 weeks, 4 weeks, 24 weeks, 2 years
Secondary outcomes (9)
Airway State on CT
airway patency by ratio compared to preoperative state
Measured: 4 weeks
white blood cell count (WBC)
Serum inflammatory markers
Measured: 4 weeks, 48 weeks, 2years
differential white blood cell count (WBC Diff)
Serum inflammatory markers
Measured: 4 weeks, 48 weeks, 2years
C-reactive protein (CRP)
Serum inflammatory markers
Measured: 4 weeks, 48 weeks, 2years
erythrocyte sedimentation rate (ESR)
Serum inflammatory markers
Measured: 4 weeks, 48 weeks, 2years
stability of bronchial wall structure
measured by bronchoscopy
Measured: 4 weeks, 48 weeks, 2years
degree of organ opening
measured by bronchoscopy
Measured: 4 weeks, 48 weeks, 2years
mucous membrane formation
measured by bronchoscopy
Measured: 4 weeks, 48 weeks, 2years
presence of inflammatory or healing tissue
measured by bronchoscopy
Measured: 4 weeks, 48 weeks, 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start17 Jul 2023
- Primary completion16 Aug 2023
- Study completion16 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Treatment group : 1 patient with bioprinted tracheal reconstruction
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ja Seong Bae, MD, phD
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Responsible party
- Sponsor-investigator, Ja Seong Bae, MD, phD, Seoul St. Mary's Hospital
- Investigators
- Sung Won Kim, MD, PhD, Study chair, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051747
- Sponsor's protocol ID
- CMCENT-02
- Status last verified
- Sep 2023
- First submitted
- 29 Aug 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park JH, Hong JM, Ju YM, Jung JW, Kang HW, Lee SJ, Yoo JJ, Kim SW, Kim SH, Cho DW. A novel tissue-engineered trachea with a mechanical behavior similar to native trachea. Biomaterials. 2015 Sep;62:106-15. doi: 10.1016/j.biomaterials.2015.05.008. Epub 2015 May 23.
PubMed 26041482Park JH, Park JY, Nam IC, Ahn M, Lee JY, Choi SH, Kim SW, Cho DW. A rational tissue engineering strategy based on three-dimensional (3D) printing for extensive circumferential tracheal reconstruction. Biomaterials. 2018 Dec;185:276-283. doi: 10.1016/j.biomaterials.2018.09.031. Epub 2018 Sep 19.
PubMed 30261427Park JH, Park JY, Nam IC, Hwang SH, Kim CS, Jung JW, Jang J, Lee H, Choi Y, Park SH, Kim SW, Cho DW. Human turbinate mesenchymal stromal cell sheets with bellows graft for rapid tracheal epithelial regeneration. Acta Biomater. 2015 Oct;25:56-64. doi: 10.1016/j.actbio.2015.07.014. Epub 2015 Jul 9.
PubMed 26163763
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of the Practical Usage Based Technology Using the Patient Customized Bioprinting Trachea for the Regeneration of Respiratory Tract (Trachea)
- ClinicalTrials.gov ID
- NCT06051747
- Acronym / sponsor ID
- CMCENT-02
- Conditions
- Thyroid Cancer
- Keywords
- Trachea
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Ja Seong Bae, MD, phDUniversity, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 16 Aug 2025 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial aims to assess the effectiveness and safety of a novel approach utilizing biopolymers, hydrogels, mucous membranes, and cartilage tissue regeneration cells integrated into 3D bioprinting technology for the creation and implantation of patient-specific tracheal organs.
Detailed description
Study Objective:
This clinical study focuses on patients with thyroid or airway diseases necessitating partial or segmental organ resection. The objective is to evaluate the feasibility, efficacy, and safety of transplanting functional patient-specific bioprinted tracheal organs as an innovative regenerative approach.
Patient Enrollment:
Patients voluntarily participate and provide written consent. A thorough screening procedure is conducted to determine their eligibility based on selection and exclusion criteria.
Bioprinting Process:
The study employs cutting-edge bioprinting technology to create complex organ tissues. Specifically, 3D cell printing is employed to fabricate a bioprinted tracheal organ. Stem cells derived from the human nasal cavity and nasal septum cartilage cells are integrated to form a cell-supporting body.
Transplantation Procedure:
Eligible patients receive transplantation of the functional patient-specific bioprinted trachea. The transplantation aims to restore tracheal functionality and address the unique challenges posed by thyroid and airway diseases.
Evaluation and Monitoring:
Following transplantation, a comprehensive assessment regimen is undertaken to evaluate both the effectiveness and safety of the procedure. This includes flexural laryngeal endoscopy, bronchoscopy, computed tomography (CT) scans, and laboratory tests.
Post-Transplant Measures:
To ensure the stability of the transplanted organ immediately after the procedure, neck fixing splints are employed to limit movement.
Thyroid Cancer Patients:
For patients diagnosed with thyroid cancer, a distinct follow-up protocol is established. A five-year observation period is implemented, extending beyond the standard follow-up for general cancer patients. Additional observations include thyroid ultrasound, Free T4, Thyroid-Stimulating Hormone (TSH), Thyroglobulin Antigen (Thyroglobulin Ag), and Anti-Thyroglobulin Antibody (Anti-TG Ab) tests conducted at the designated observation points.
This study seeks to contribute novel insights into the realm of regenerative medicine and enhance the understanding of patient-specific bioprinting technology as a potential solution for tracheal and airway diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Treatment group : 1 patient with bioprinted tracheal reconstruction
| Arm | Type | Receives |
|---|---|---|
| Treated | Experimental | Procedure: Three-dimensional patient-specific bioprinting trachea implantationThree-dimensional patient-specific bioprinting trachea implantation |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age Range:
- Individuals between 19 and 75 years of age are eligible for participation.
- Specific Medical Condition:
- Patients must meet the following criteria and have thyroid or airway diseases necessitating partial or segmental resection:
- For patients with thyroid cancer, inclusion is based on TNM staging, specifically stage II or higher differentiated thyroid cancer patients. Verification of complete removal through a freeze section test during surgery in accordance with the staging system for papillary carcinoma of the trachea is essential (Hum Pathol. 1993 Aug; 24(8):866-70).
Key exclusion criteria (14 listed)
- Pregnancy and Lactation:
- Pregnant or lactating women are excluded from participation in the study.
- Prior Thyroid or Airway Surgery:
- Individuals who have undergone thyroid or airway peripheral surgery before undergoing screening are ineligible for participation.
- Persistent Inflammation:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-dimensional patient-specific bioprinting trachea implantationThe intervention entails the creation of a 3D cell-printed tracheal organ, achieved through the fusion of biopolymer materials and the bioprinting (3D cell printing) technique. This process involves distribution of nasal cavity stem cells (hNTSCs) and nasal septum cartilage cells (hNCs) within hydrogel matrices, culminating in the formation of a personalized tracheal structure. | Procedure or surgery | Treated |
Primary outcome
airway lumen opening rate
Time frame: 1 week, 2 weeks, 4 weeks, 24 weeks, 2 years
measured by curved laryngeal endoscopy
crust formation degree
Time frame: 1 week, 2 weeks, 4 weeks, 24 weeks, 2 years
measured by curved laryngeal endoscopy
granuloma formation degree
Time frame: 1 week, 2 weeks, 4 weeks, 24 weeks, 2 years
measured by curved laryngeal endoscopy
degree of inflammation
Time frame: 1 week, 2 weeks, 4 weeks, 24 weeks, 2 years
measured by curved laryngeal endoscopy
other relevant findings
Time frame: 1 week, 2 weeks, 4 weeks, 24 weeks, 2 years
measured by curved laryngeal endoscopy
9 secondary outcomes
Airway State on CT
Time frame: 4 weeks
white blood cell count (WBC)
Time frame: 4 weeks, 48 weeks, 2years
differential white blood cell count (WBC Diff)
Time frame: 4 weeks, 48 weeks, 2years
C-reactive protein (CRP)
Time frame: 4 weeks, 48 weeks, 2years
erythrocyte sedimentation rate (ESR)
Time frame: 4 weeks, 48 weeks, 2years
stability of bronchial wall structure
Time frame: 4 weeks, 48 weeks, 2years
degree of organ opening
Time frame: 4 weeks, 48 weeks, 2years
mucous membrane formation
Time frame: 4 weeks, 48 weeks, 2years
presence of inflammatory or healing tissue
Time frame: 4 weeks, 48 weeks, 2years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Results publication: PubMed 26041482Park JH, Hong JM, Ju YM, Jung JW, Kang HW, Lee SJ, Yoo JJ, Kim SW, Kim SH, Cho DW. A novel tissue-engineered trachea with a mechanical behavior similar to native trachea. Biomaterials. 2015 Sep;62:106-15. doi: 10.1016/j.biomaterials.2015.05.008. Epub 2015 May 23.
- Results publication: PubMed 30261427Park JH, Park JY, Nam IC, Ahn M, Lee JY, Choi SH, Kim SW, Cho DW. A rational tissue engineering strategy based on three-dimensional (3D) printing for extensive circumferential tracheal reconstruction. Biomaterials. 2018 Dec;185:276-283. doi: 10.1016/j.biomaterials.2018.09.031. Epub 2018 Sep 19.
- Results publication: PubMed 26163763Park JH, Park JY, Nam IC, Hwang SH, Kim CS, Jung JW, Jang J, Lee H, Choi Y, Park SH, Kim SW, Cho DW. Human turbinate mesenchymal stromal cell sheets with bellows graft for rapid tracheal epithelial regeneration. Acta Biomater. 2015 Oct;25:56-64. doi: 10.1016/j.actbio.2015.07.014. Epub 2015 Jul 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung Won Kim, MD, PhD study chair
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Three-dimensional patient-specific bioprinting trachea implantation in people with Thyroid Cancer, run by Ja Seong Bae, MD, phD at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
airway lumen opening rate (time frame: 1 week, 2 weeks, 4 weeks, 24 weeks, 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06051747, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.