MSC Intratissular Injection in Crohn Disease Patients

Официальное название

Treatment of Refractory Crohn's Disease Lesions by Local Injection of Mesenchymal Stem Cells

Обзор

The main objective is to assess the efficacy of local injection of MSC on the healing of refractory intestinal and perianal lesions in crohn disease. The second co-primary endpoint is safety.

Вмешательства

• Биопрепарат Mesenchymal Stromal Cells
  Suspension of mesenchymal stromal cells for intratissular injection

Первичные конечные точки

• Proportion of patients with deep ulcer healing [Срок оценки: Week 12]
• Proportion of patients with stricture healing [Срок оценки: Week 12]
• Proportion of patients with complex perianal fistula healing [Срок оценки: Week 12]
• Safety assessed by the incidence of treatment-emergent adverse events during the study period [Срок оценки: from week 0 to week 48]

Вторичные конечные точки (4)

• Evolution of clinical disease activity index [Срок оценки: week 0, 12 and 48]
• Evolution of Short health scale (quality of life) [Срок оценки: week 0, 12 and 48]
• Evolution of the Lemann Index (measuring cumulated intestinal damage in Crohn's disease) [Срок оценки: week 0, 12 and 48]
• Evolution of the " Group of Therapeutic Study of Inflammatory Disorders of the Digestive Tube" obstructive score for Crohn Disease strictures [Срок оценки: weeks 0, 12 and 48]

Критерии участия

Критерии включения

• Patients ≥ 18 years of age
• Signing the informed consent
• Diagnosis of Crohn Disease for more than 6 months
• Presence of at least one Crohn Disease lesion refractory to conventional therapies (azathioprine, 6-mercaptopurine or methotrexate) and to biologic treatments (anti-Tumor Necrosis Factor 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).
• Twenty patients with stricture(s), 20 patients with unhealed deep ulcer(s), and 20 patients with an actively draining perianal fistula(s) will be included

Критерии исключения

• Indication for immediate luminal surgery
• 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, Glomerular Filtration Rate < 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
• an 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• CHU de Liège — Liège

Идентификаторы

NCT: NCT03901235 · TJT1707P1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗