2024-514033-37-00暂停2 期
Treatment of refractory Crohn's disease lesions by local injection of mesenchymal stem cells
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The first co-primary endpoint will be the complete or partial healing of the refractory lesion at 12 weeks.
研究概览
简要总结
To assess the safety and efficacy of local injection of mesenchymal stem cells on healing of refractory intestinal and perianal lesions in Crohn’s disease
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 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years of age
- •Patients signing the informed consent
- •Diagnosis of Crohn's Disease for more than 6 months
- •Presence of at least one CD lesion refractory to conventional therapies (azathioprine, 6- mercaptopurine or methotrexate) and to biologic treatments (anti-TNF therapies, vedolizumab, or ustekinumab).
- •Refractory lesion defined by (1) a stricture with a length of 2 to 5cm of the colon or the ileum accessible by ileocolonoscopy (i.e. a lesion identified during a colonoscopy with a lumen narrowing non passable by the colonoscope), (2) unhealed deep ulcer of the colon or the ileum accessible to ileocolonoscopy, or (3) actively draining perianal fistula(s)
- •15 patients with stricture(s), 5 patients with unhealed deep ulcer(s), and 50 patients with an actively draining perianal fistula(s) will be included.
排除标准
- •Indication for immediate luminal surgery
- •Opportunistic infection within 6 months before screening or a serious infection in the previous 3 months
- •Malignancy within the past 5 years; or a history of lymphoproliferative disease
- •Intestinal obstruction
- •Intra-abdominal fistulas or abscess
- •Intestinal/colonic stricture or deep unhealed ulcer not accessible to ileocolonoscopy
- •Undrained peri-anal abscess
- •Pregnant women or planning pregnancy within one year
- •Positive stool culture/toxin for clostridium difficile pathogen or other pathogens
- •Renal failure (anuria, serious fluid overload, GFR < 30 ml/min, dialysis) or hepatic failure (fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin >3 mg/dL)
- •Documented human immunodeficiency virus infection; active hepatitis B, C, or tuberculosis
结局指标
主要结局
The first co-primary endpoint will be the complete or partial healing of the refractory lesion at 12 weeks.
The first co-primary endpoint will be the complete or partial healing of the refractory lesion at 12 weeks.
The second co-primary endpoint is safety, assessed by monitoring for adverse and serious adverse events and changes in vital signs at the day of treatment and at all follow-up visits.
The second co-primary endpoint is safety, assessed by monitoring for adverse and serious adverse events and changes in vital signs at the day of treatment and at all follow-up visits.
次要结局
- Complete or partial healing of the refractory lesion at 48 weeks
- Evolution of the Patient Reported Outcomes (PRO), between week 0, 12 and 48, including pain, general well-being and number of stools per day
- Evolution of Crohn's Disease Activity Index (CDAI) between weeks 0, 12 and 48
- Evolution of the Short health scale SHS (quality of life) between week 0, 12 and 48
- Evolution of the Lemann Index between week 0, 12 and 48
- Evolution of the GETAID obstructive score for Crohn's Disease strictures between weeks 0, 12 and 48
- Disappearance or improvement of intestinal or colonic ulcers/stricture at MRI at 12 and 48 weeks
- Incidence of specific safety outcomes all over the study period and more specifically at week 0, 4, 12, 24, and 48: (1) the occurrence of an obstruction requiring hospitalisation and fasting for at least 24 hours, (2) the occurrence of an intestinal perforation, (3) the development of an intra-abdominal fistula and/or abscess, (4) perianal abscess, (5) new perianal fistulous track.
研究者
Prof. Edouard Louis
Scientific
Centre hospitalier universitaire de Liege
研究点 (1)
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