Development of the Practical Usage Based Technology Using the Patient Customized Bioprinting Trachea for the Regeneration of Respiratory Tract (Trachea)
Phase: PHASE1
Conditions: Thyroid Cancer
Sponsor: Ja Seong Bae, MD, phD

Clinical Trial Protocol
Protocol No. 3D Bioprinting Trachea 
 
 
 
 
Clinical Trial Protocol 
 
 
Patient-Customized Bioprinting Technology for Practical Regeneration of the 
Respiratory Tract (Trachea) 
 
 
 
Protocol No. 
:  3D Bioprinting Trachea 
Protocol Version 
:  2.3 
Development date 
:  2023-05-26 
 
 
 
 
 
 
 
 
 
 
 
 
 

Clinical Trial Protocol
Protocol No. 3D Bioprinting Trachea 
 
CLINICAL TRIAL PROTOCOL: CLINICAL RESEARCH PLAN OVERVIEW 
Professor Bae Ja-sung, Seoul St. Mary's Hospital 
Patient-Customized Bioprinting Technology for Practical 
Regeneration of the Respiratory Tract (Trachea) 
Study Title 
Patient-Customized 
Bioprinting 
Technology 
for 
Practical 
Regeneration of the Respiratory Tract (Trachea) 
Principal 
Investigator 
Professor Bae Ja-sung, Catholic University of Korea, Seoul St. Mary's Hospital
Clinical Research 
Institution 
Catholic University of Korea, Seoul St. Mary's Hospital 
Reference 
Bae Ja-sung, et al. Rational Tissue Engineering Strategy for Extensive 
Circumferential Tracheal Reconstruction Using Three-Dimensional (3D) 
Printing. Biomaterials. 2018;185:276-283. 
Period 
72 months from IRB approval 
date 
Stage 
Cell 
therapy 
phase 
for 
academic purposes 
Objective 
This clinical study aims to assess the effectiveness and safety of transplanting 
3D patient-specific bioprinted tracheal organs using biopolymers, hydrogels, 
and tissue regeneration cells for respiratory tract regeneration. 
Methods 
Participants with thyroid or airway diseases necessitating partial or segmental 
resection will be enrolled after providing written consent. Screening tests will 
determine eligibility. The 3D bioprinted trachea, incorporating stem cells from 
the nasal cavity and nasal septum cartilage, will be transplanted. Evaluation 
includes endoscopy, bronchoscopy, CT, and lab tests. Neck fixing splints will 
stabilize transplanted areas post-surgery. Thyroid cancer patients will have 
extended follow-up with specific tests. 
Number 
of 
Participants 
1 
Target Disease 
Congenital tracheal softening, traumatic tracheal stenosis, tracheal defects 
post-thyroid cancer surgery, requiring partial or segmental resection 
Selection/Exclusio
n Criteria 
Selection Criteria: 
 
Adults aged 19-75 
 
Patients meeting criteria for thyroid or airway disease requiring resection
 
Patients with thyroid cancer invading the trachea, requiring resection with 
expected organ dysfunction post-surgery 
 
Patients with organ defects around cartilage (>30%), suitable for 3D 
bioprinting 
 
Female participants using contraception during the study 
 
Participants providing informed consent 

Clinical Trial Protocol
Protocol No. 3D Bioprinting Trachea 
 
 
Exclusion Criteria: 
 
Pregnant or lactating women 
 
Prior thyroid or airway peripheral surgery 
 
Inflammation of thyroid or surrounding tissues 
 
Systemic inflammatory disease 
 
High risk due to liver, kidney, or heart disease 
 
Sepsis or hemorrhagic predisposition 
 
Prior radiotherapy to head/neck 
 
Recent use of other research medications/devices 
 
History of cell therapy 
 
Malignant tumors other than thyroid cancer 
 
Other deemed inappropriate for the study 
Product 
Description 
 
3D cell-printed trachea using patient-specific cells (hNTSCs, hNCs) and 
hydrogels 
Patient-specific single-product bioprinted trachea 
No artificial genetic manipulation 
Validity 
Assessment 
Primary Variables: 
 
Endoscopic findings after 1, 2, 4, and 24 weeks 
 
Airway intraluminal clearance rate 
 
Degree of granuloma and bark formation 
 
Inflammation and other findings 
 
Secondary outcome 
 
CT-based airway condition comparison 
 
Postoperative inflammatory levels (WBC, WBC Diff, CRP, ESR) 
 
Bronchoscopy findings (wall stability, tracheal opening, mucosal formation, 
inflammation/granulation) 
Safety 
Assessment 
Abnormal responses, vital signs, ECG, lab tests, physical exam