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

NCT06051747 | Unknown Phase 1

• 1 other identifier: CMCENT-02
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer

Keywords

Trachea

Outcome Measures

Primary Outcomes (5)

• airway lumen opening rate

  measured by curved laryngeal endoscopy

  1 week, 2 weeks, 4 weeks, 24 weeks, 2 years

• crust formation degree

  measured by curved laryngeal endoscopy

  1 week, 2 weeks, 4 weeks, 24 weeks, 2 years

• granuloma formation degree

  measured by curved laryngeal endoscopy

  1 week, 2 weeks, 4 weeks, 24 weeks, 2 years

• degree of inflammation

  measured by curved laryngeal endoscopy

  1 week, 2 weeks, 4 weeks, 24 weeks, 2 years

• other relevant findings

  measured by curved laryngeal endoscopy

  1 week, 2 weeks, 4 weeks, 24 weeks, 2 years

Secondary Outcomes (9)

• Airway State on CT

  4 weeks

• white blood cell count (WBC)

  4 weeks, 48 weeks, 2years

• differential white blood cell count (WBC Diff)

  4 weeks, 48 weeks, 2years

• C-reactive protein (CRP)

  4 weeks, 48 weeks, 2years

• erythrocyte sedimentation rate (ESR)

  4 weeks, 48 weeks, 2years

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  1 week, 2 weeks, 4 weeks, 24 weeks, 48 weeks, 72 weeks, 2 years

Study Arms (1)

Treated

EXPERIMENTAL

Three-dimensional patient-specific bioprinting trachea implantation

Procedure: Three-dimensional patient-specific bioprinting trachea implantation

Interventions

Three-dimensional patient-specific bioprinting trachea implantation PROCEDURE

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.

Treated

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ja Seong Bae, MD, phD: lead
• Korea Health Industry Development Institute: collaborator

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Related Publications (3)

• 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.

  PMID: 26041482 RESULT

• Park 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.

  PMID: 30261427 RESULT

• Park 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.

  PMID: 26163763 RESULT

MeSH Terms

Conditions

Thyroid Neoplasms; Tracheal Diseases

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Respiratory Tract Diseases

Study Officials

• Sung Won Kim, MD, PhD

  Seoul St. Mary's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Treatment group : 1 patient with bioprinted tracheal reconstruction

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 25, 2023
• Study Start: July 17, 2023
• Primary Completion: August 16, 2023
• Study Completion: August 16, 2025
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)