NCT03901235RecruitingPhase 1/2
MSC Intratissular Injection in Crohn Disease Patients
Treatment of Refractory Crohn's Disease Lesions by Local Injection of Mesenchymal Stem Cells
Source: ClinicalTrials.gov · Last updated 12 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 4 Mar 2019
- Start date
- 15 Jan 2018
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Liege
- Diseases
- Crohn's disease
- NCT number
- NCT03901235
- EU CT number
- 2024-514033-37-00
- EudraCT number
- 2017-002653-11
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 60
- From 15 Jan 2018 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Indication for immediate luminal surgery
- an opportunistic infection within 6 months before screening or a serious infection in the previous 3 months
Other illness
- Intestinal/colonic stricture or deep unhealed ulcer not accessible to ileocolonoscopy
- documented human immunodeficiency virus infection; active hepatitis B, C, or tuberculosis
- malignancy within the past 5 years; or a history of lymphoproliferative disease
Lab values
- 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)
Other
- Intestinal obstruction
- Intra-abdominal fistulas or abscess
- Undrained peri-anal abscess
- Pregnant women or planning pregnancy within one year
- Positive stool culture/toxin for clostridium difficile pathogen or other pathogens
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.