NCT05626023已完成1 期
A Phase I Study to Evaluate the Safety and Tolerability of Human TH-SC01 Cell Injection for the Treatment of Perianal Fistulas in Crohn's Disease
Jiangsu Topcel-KH Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2022年1月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease
详细描述
This study is a phase 1, single-arm, safety and tolerability study of human TH-SC01 cell injection for perianal fistulas in Crohn's Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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 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 ≤
- •Subjects with perianal fistula confirmed by clinical assessment and MRI.
- •Subjects aged between 18 and 70, both male and female.
- •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.
- •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 gentamicin sulfate, anesthetics or contrast media.
- •Subjects allergic to MRI contrast.
- •Subjects who has received stem cells in a previous clinical study or as a therapeutic agent.
- •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.
研究组 & 干预措施
Human TH-SC01 cell injection
Experimental
Single injection of 0.6×10^7, 1.2×10^8, 1.8×10^8 cells/kg
干预措施: Human TH-SC01 cell injection (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: 84 days
Exploration of maximum tolerated dose (MTD)
Severity and incidence of adverse events
时间窗: 28 days
Severity and incidence of adverse events within 28 days after adiministration
Dose-limiting toxicity (DLT)
时间窗: 84 days
Exploration of dose-limiting toxicity (DLT)
次要结局
- Crohn's Disease Activity Index (CDAI) score(84 days)
- Perianal fistula healing(84 days)
- Perianal Disease Activity Index (PDAI)(84 days)
- Inflammatory Bowel Disease Questionnaire（IBDQ）score(84 days)
- VAS score(84 days)
- Anal sphincter function：Wexner incontinence score(84 days)
- Anal sphincter function： rectal pressure(84 days)
研究者
研究点 (1)
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