NCT05677672Unknown1 期
Phase I/Ⅱ Study to Evaluate the Safety and Efficacy of Human TH-SC01 Cell Injection in the Treatment of Complex Perianal Fistula
Jiangsu Topcel-KH Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2022年12月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of human TH-SC01 cell injection for the treatment of complex perianal fistulas
详细描述
This study is a phase Ⅰ/Ⅱ study, Phase 1 was the dose increment phase, and phase 2 was the expansion phase
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Subjects aged between 18 and 70, both male and female.
- •The subject was clinically diagnosed as complex anal fistula. The diagnostic criteria for complex anal fistula were adopted by the 2016 American Association of Colorectal Surgeons Guidelines for the Treatment of Perianal Abscess, Anal Fistula and Rectovaginal Fistula.
- •The subjects had received conventional treatment for anal fistulas
- •All subjects and their partners were not planning to have a child from screening to the end of the trial and agreed to use effective non-drug contraception during the trial.
排除标准
- •Subjects with anal fistula in the acute infection period.
- •Subjects with abscess or collections >2 cm.
- •Subjects with abnormal laboratory results: liver function: total bilirubin >=1.5 × ULN, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >=2 × ULN; renal function: creatinine clearance below 60 mL/minute calculated using Cockcroft-Gault formula or by serum creatinine >=1.5 × upper limit of normal (ULN).
- •Subjects with malignant tumors or a history of malignant tumors.
- •Subjects with severe, progressive, uncontrolled hepatic, hematological, gastrointestinal (except Crohn's disease), endocrine, pulmonary, cardiac, neurological, psychiatric, or cerebral diseases.
- •Serum virology test (HBeAg, HCV antibody, HIV antibody, Treponema pallidum antibody) positive.
- •Subjects allergic to gentamicin sulfate, anesthetics or contrast media.
- •Subjects allergic to MRI contrast.
- •Subjects who has major surgery or severe trauma within 6 months prior to the screening period.
- •Subjects who has received any investigational drug within 3 months prior to the screening.
- •Subjects deemed inappropriate by the investigator to participate in this clinical trial.
- •The female participant who is pregnant, or is lactating.
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: Day 28
Exploration of dose-limiting toxicity (DLT)
Severity and incidence of study drug-related adverse-events
时间窗: Day 28 (Week 4)
Severity and incidence of study drug-related adverse-events within D28(W4) after administration.
maximum tolerated dose (MTD)
时间窗: Day 28
Exploration of maximum tolerated dose(MTD)
Percentage of effectiveness
时间窗: Day 84
Percentage of effectiveness at 84 days of administration by MRI imaging evaluated fistula healing with no or minimal effusion
次要结局
- Severity and incidence of study drug-related adverse-events(Day 28)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's DiseasePerianal FistulaCrohn's DiseaseNCT05626023Jiangsu Topcel-KH Pharmaceutical Co., Ltd.9
进行中（未招募）
1 期
A Study of iPS Cell-derived Cardiomyocyte Spheroids (HS-001) in Patients With Heart Failure (LAPiS Study)Ischemic Heart DiseaseHeart FailureNCT04945018Heartseed Inc.10
已完成
1 期
hCT-MSC Infusion in Adults With Autism Spectrum DisorderAutism Spectrum DisorderAutismNCT04484077Joanne Kurtzberg, MD8
已完成
1 期
Safety and Efficacy Study of Human T Lymphoid Progenitor (HTLP) Injection After Partially HLA Compatible Allogeneic Hematopoietic Stem Cell Transplantation in SCID PatientsPediatric PatientsAny Type of Severe Combined Immunodeficiency (SCID)Partial HLA Incompatible Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)NCT03879876Assistance Publique - Hôpitaux de Paris4
进行中（未招募）
1 期
A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid TumorsAdvanced CancerGastroesophageal-junction CancerPancreatic CancerGastric CancerNCT04396821Suzhou Transcenta Therapeutics Co., Ltd.150