NCT06429241招募中1 期
A Phase I Clinical Study Evaluating the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Perianal Fistula
Jiangsu Topcel-KH Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2024年4月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Standardized uptake value
研究概览
简要总结
The purpose of this study is to evaluate the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula
详细描述
A Phase I clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Subjects with Crohn's disease or complex perianal fistula diagnosed at least 6 months earlier according to the Chinese Consensus Opinion on the Diagnosis and Treatment of Inflammatory Bowel Diseases (Beijing, 2018).Subjects with active perianal fistula and non active luminal CD defined by a CDAI ≤
- •For patients with perianal fistula, 1≤ the number of internal openings ≤2, and 1≤ the number of external openings ≤3, the fistula of the patient needs to be drained smoothly
- •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.
- •ECOG score 0~1, ASA grade I~II
- •Subjects failed to respond to adequate treatment with any of the conventional antibiotics, immunomodulatory drugs (including steroids), anti-tumor necrosis factor-α (TNF-α) monoclonal antibodies and other biological agents.
排除标准
- •Subjects with active infection evaluated by the investigator.
- •Subjects with Crohn's disease requiring immediate therapy.
- •Subjects with abscess or collections >2 cm.
- •Subjects with rectal and/or anal stenosis and/or active proctitis.
- •Subjects who treated with systemic steroids in the 4 weeks prior to stem cells administration.
- •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 Human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic drug
- •Subjects who has received stem cells therapy.
- •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.
- •Not suitable for PET/CT examination.
- •Participants considered inappropriate to participate in this clinical trial
结局指标
主要结局
Standardized uptake value
时间窗: 8-12 hour、32-36 hour、56-60 hour、104-108 hour、152-156 hour，296-300 hour
Standardized values of organs or tissues after PET/CT imaging after local injection in patients with perianal fistula
次要结局
- Effectiveness endpoint:Proportion of subjects with clinically significant effect at week 24 after local injection(Week 1，Week 4，Week 24)
- Radiation exposure: Uptake rate (%ID), absorbed dose, and systemic effective dose in vital organs or tissues after local injection of nuclide labeled TH-SC01 cells.(Week 1)
- Safety endpoint: Treatment-related adverse events/adverse reactions, serious adverse events/serious adverse events(Week 1，Week 4，Week 24，Month 24)
研究者
研究点 (1)
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