Development of the Practical Usage Based Technology Using the Patient Customized Bioprinting Trachea for the Regeneration of Respiratory Tract (Trachea)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- airway lumen opening rate
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
- •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.
排除标准
- •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.
- •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.
结局指标
主要结局
airway lumen opening rate
时间窗: 1 week, 2 weeks, 4 weeks, 24 weeks, 2 years
measured by curved laryngeal endoscopy
crust formation degree
时间窗: 1 week, 2 weeks, 4 weeks, 24 weeks, 2 years
measured by curved laryngeal endoscopy
degree of inflammation
时间窗: 1 week, 2 weeks, 4 weeks, 24 weeks, 2 years
measured by curved laryngeal endoscopy
granuloma formation degree
时间窗: 1 week, 2 weeks, 4 weeks, 24 weeks, 2 years
measured by curved laryngeal endoscopy
other relevant findings
时间窗: 1 week, 2 weeks, 4 weeks, 24 weeks, 2 years
measured by curved laryngeal endoscopy
次要结局
- presence of inflammatory or healing tissue(4 weeks, 48 weeks, 2years)
- degree of organ opening(4 weeks, 48 weeks, 2years)
- Airway State on CT(4 weeks)
- 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)
- stability of bronchial wall structure(4 weeks, 48 weeks, 2years)
- mucous membrane formation(4 weeks, 48 weeks, 2years)
- white blood cell count (WBC)(4 weeks, 48 weeks, 2years)
研究者
Ja Seong Bae, MD, phD
Professor
Seoul St. Mary's Hospital