2025-523699-21-00撤回1 期
An open label safety and efficacy study of allogenic adipose tissue-derived mesenchymal stromal cells on autism and gastrointestinal symptoms
Cell to Cure ApS1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月23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
- 40
- 试验地点
- 1
- 主要终点
- Number of adverse reactions (ARs) and serious adverse reactions (SARs)
研究概览
简要总结
To assess safety of intravenous infusion of in vitro expanded adipose tissue-derived mesenchymal stromal cells (ASCs) used for allogenic treatment of children with autism spectrum disorder (ASD) and gastrointestinal symptoms.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Aged 6-18 years (both inclusive)
- •Diagnosis of autism spectrum disorder
- •Ongoing gastrointestinal symptoms
排除标准
- •If known genetic syndrome or pathogenic mutation or copy number variation associated with autism spectrum disorder
- •Known CNS-infection (now or previously) and/or HIV positivity
- •Primary immunodeficiency disorder or autoimmune cytopenia
- •Celiac disease or inflammatory bowel disease (Crohn’s disease or ulcerative colitis)
- •Current treatment with cytotoxic drugs or systemic administered glucocorticoids and/or immunosuppressive therapy or other anti-inflammatory medication (except nonsteroidal anti-inflammatory drugs)
结局指标
主要结局
Number of adverse reactions (ARs) and serious adverse reactions (SARs)
Number of adverse reactions (ARs) and serious adverse reactions (SARs)
次要结局
- Change in Vineland Adaptive Behavior Scales (questionnaire)
- Change in Children Communication Checklist-2 (questionnaire)
- Change in IBS-QoL - Irritable Bowel Syndrome Quality of Life (questionnaire)
研究者
Tania Poulsen
Scientific
Cell to Cure ApS
研究点 (1)
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