NCT04435249撤回1 期
Phase I/II, Open Label Study to Assess the Safety and Efficacy Autologous Bone Marrow-derived Mesenchymal Stromal Cells Seeded on to Decellularised Airway Scaffold in Subjects with Clinically Significant Bronchopleural Fistula
Videregen Limited0 个研究点目标入组 5 人开始时间: 2025年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 5
- 主要终点
- Safety: Emergent or worsening Serious Adverse Events (SAEs) related to the BPF implant during the 3 months post-defect repair
研究概览
简要总结
Phase I/II Open-label Study to Assess the Safety and Efficacy of a Novel Tissue Engineered Airway Product, Consisting of Expanded Autologous Bone Marrow (BM) Derived Mesenchymal Stromal Cells (MSC) Seeded on to a Decellularised Allogeneic Patch of an Airway Scaffold in Subjects With Clinically Significant Bronchopleural Fistula.
详细描述
The proposed clinical trial is a phase I/II open-label study to assess the safety and efficacy of a novel tissue engineered airway product, consisting of expanded autologous Bone Marrow (BM) derived Mesenchymal Stromal Cells (MSC) seeded on to a decellularised allogeneic patch of an airway scaffold in subjects with clinically significant bronchopleural fistula. It is a phase I/II open-label study, which is an uncontrolled pilot in 5 subjects.
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
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 18 years or older.
- •Documented diagnoses of BPF through imaging and bronchoscopic examination.
- •BPF which involves the tracheobronchial junction or proximal bronchus.
- •Subjects who have failed primary repair.
- •Subjects who have no evidence of any primary or recurrent cancer (not limited to the surgical site) at the time of pre-operative screening as evidenced by CT and/or targeted biopsy (except for controlled or controllable basal cell carcinoma.
- •Subjects who have signed and dated written informed consent to participate in the study.
- •Females of childbearing potential (i.e. not surgically sterilised or post-menopausal for at least 2 years) must have a negative serum or urine pregnancy test.
- •Male and female subjects of childbearing potential (i.e. not surgically sterilised or post-menopausal for at least 2 years) must use forms of highly effective methods of contraception, which are defined as hormonal methods of contraception (oral, injection or implant), barrier methods (condom or occlusive cap (diaphragm or cervical/vault caps)) with spermicidal foam/gel/cream/film/suppository, or true abstinence for 1 month following surgery.
- •Subjects who have produced viable cells from Bone Marrow Aspirate.
排除标准
- •Subjects who have received previous treatment with another Advanced Technology Medicinal Product (ATMP).
- •Subjects with ECOG performance status of 3 or
- •Subjects deemed not suitable for surgery by the MDT.
- •Uncontrolled diabetes, defined as HbA1c levels above 7.0 %.
- •Any medical condition contraindicating the ability to tolerate general anaesthetic in the judgement of a consultant anaesthetist.
- •Subjects who have a severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
- •Subjects with clinically significant renal and liver impairment.
- •Subjects undergoing an immunosuppression regimen or suffering from a primary immunodeficiency syndrome.
- •Subjects with any known hypersensitivity to the culture and transport media compounds.
- •Subjects with current or recurrent disease that could affect the administration, the action or disposition of the investigational product, or clinical or laboratory assessments.
- •Subjects with clinically relevant or recent (within 2 years) history of substance abuse, including alcohol.
- •Subject who has participated in any other interventional clinical trial within previous 30 days of the start of this study.
- •Subjects with known presence of Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody.
- •Subject who, in the investigator's judgement, is unlikely to complete all protocol required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
- •Subjects with any medical condition, that in the investigator's judgement, is likely to interfere with assessment of safety or efficacy of study treatment.
- •Subject who is pregnant.
- •Subjects with cancer (except for controlled or controllable basal cell carcinoma).
结局指标
主要结局
Safety: Emergent or worsening Serious Adverse Events (SAEs) related to the BPF implant during the 3 months post-defect repair
时间窗: 3 months (90 days)
Safety: Emergent or worsening Serious Adverse Events (SAEs) related to the BPF implant during the 3 months post-defect repair.
Efficacy: Bronchopleural Fistula (BPF) closure at 3 months assessed by visual appearance and no clinical signs of leaks.
时间窗: 3 months (90 days)
Closure of BPF with no need for further surgical closure. Efficacy will be deemed demonstrated if 2 or more subjects meet the primary endpoint.
次要结局
- Change from Baseline in Physiological and Quality of Life scores at 3, 6, 9, 12 months, Evaluation Questionnaire 5D (EQ-5D), 6-minute walking test (6MWT), ambulatory oxygen (O2).(36 months)
- Safety and tolerability: - Adverse Events (AEs) including pre-defined postoperative AEs of special interest up to 30± 3 days post implantation- Related AEs reported after 3, 6, 9, 12, 24 and 36 months(36 months)
- Viability and the integrity of the repair area (closure) visually via bronchoscope. Integrity assessed by visual appearance of no visible leaks- Structural closure of the defect and visual health of the defect area and surrounding tissue(36 months)
- Absence of other surgical interventions at 6, 9, 12, 24 and 36 months(36 months)
研究者
相似试验
暂停
1 期
A Study to Assess the Safety, Tolerability and Potential Efficacy of a Tracheal Replacement Consisting of a Tissue-engineered Tracheal Scaffold With Seeded Mesenchymal CellsTracheomalaciaTracheal StenosisNCT02949414Cell Therapy Catapult4
尚未招募
1 期
Assessment of new airway device [Gnana Laryngeal Airway]: a preliminary clinical study.CTRI/2017/12/010782Director Principal
Unknown
1 期
Clinical Study to Determine Safety and Effectiveness of KEEPASLEEP Device in Simple Snorers.SnoringSleep Apnea SyndromesNCT00211627Miller, Chipp St. Kevin, M.D.30
已完成
1 期
Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal DiseaseEnd-stage Renal DiseaseKidney Failure, ChronicNCT01840956Humacyte, Inc.20
已完成
不适用
Evaluation of the Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With ESRDEnd-stage Renal DiseaseKidney Failure, ChronicNCT01744418Humacyte, Inc.40