Patient-Customized Bioprinting Technology for Practical Regeneration of the Respiratory Tract (Trachea)

Phase 1

Active, not recruiting

• Conditions: Thyroid Cancer
• Interventions: Procedure: Three-dimensional patient-specific bioprinting trachea implantation

• Registration Number: NCT06051747
• Lead Sponsor: Ja Seong Bae, MD, phD

Brief 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.

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 Timeline

• Study Start: 2023-07-17
• Primary Completion: 2023-08-16
• Study First Submitted: 2023-08-29
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-20
• Last Update Submitted: 2023-09-20
• Study First Posted: 2023-09-25
• Last Update Posted: 2023-09-25
• Study Completion: 2025-08-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

1. Age Range:

   Individuals between 19 and 75 years of age are eligible for participation.

2. Specific Medical Condition:

   Patients must meet the following criteria and have thyroid or airway diseases necessitating partial or segmental resection:

   1. 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).

      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.

   2. 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.

3. 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.

4. Informed Consent:

Participants must voluntarily provide written consent after receiving a comprehensive explanation of the clinical study.

Exclusion Criteria

1. Pregnancy and Lactation:

   Pregnant or lactating women are excluded from participation in the study.

2. Prior Thyroid or Airway Surgery:

   Individuals who have undergone thyroid or airway peripheral surgery before undergoing screening are ineligible for participation.

3. Persistent Inflammation:

   Patients with ongoing inflammation of the thyroid or surrounding tissues at the time of screening are excluded.

4. Systemic Inflammatory Disease:

   Patients diagnosed with systemic inflammatory diseases at the screening stage are not eligible to participate.

5. 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.

6. Sepsis:

   Patients diagnosed with sepsis at the time of screening are not eligible for participation.

7. Hemorrhage Predisposition:

Individuals with a predisposition to hemorrhage at the time of screening are excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treated	Three-dimensional patient-specific bioprinting trachea implantation	Three-dimensional patient-specific bioprinting trachea implantation

Primary Outcome Measures

Name	Time	Method
airway lumen opening rate	1 week, 2 weeks, 4 weeks, 24 weeks, 2 years	measured by curved laryngeal endoscopy
crust formation degree	1 week, 2 weeks, 4 weeks, 24 weeks, 2 years	measured by curved laryngeal endoscopy
degree of inflammation	1 week, 2 weeks, 4 weeks, 24 weeks, 2 years	measured by curved laryngeal endoscopy
granuloma formation degree	1 week, 2 weeks, 4 weeks, 24 weeks, 2 years	measured by curved laryngeal endoscopy
other relevant findings	1 week, 2 weeks, 4 weeks, 24 weeks, 2 years	measured by curved laryngeal endoscopy

Secondary Outcome Measures

Name	Time	Method
degree of organ opening	4 weeks, 48 weeks, 2years	measured by bronchoscopy
presence of inflammatory or healing tissue	4 weeks, 48 weeks, 2years	measured by bronchoscopy
Airway State on CT	4 weeks	airway patency by ratio compared to preoperative state
differential white blood cell count (WBC Diff)	4 weeks, 48 weeks, 2years	Serum inflammatory markers
C-reactive protein (CRP)	4 weeks, 48 weeks, 2years	Serum inflammatory markers
erythrocyte sedimentation rate (ESR)	4 weeks, 48 weeks, 2years	Serum inflammatory markers
stability of bronchial wall structure	4 weeks, 48 weeks, 2years	measured by bronchoscopy
mucous membrane formation	4 weeks, 48 weeks, 2years	measured by bronchoscopy
white blood cell count (WBC)	4 weeks, 48 weeks, 2years	Serum inflammatory markers

Trial Locations

Locations (1)

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of