Injecting stem cells to heal Crohn's disease lesions
Treatment of Refractory Crohn's Disease Lesions by Local Injection of Mesenchymal Stem Cells
This study is testing if injecting stem cells can help heal stubborn lesions in adults with Crohn's disease that haven't improved with other treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Liege Academic / other |
| Drugs / interventions | vedolizumab, ustekinumab, methotrexate |
| Locations | 1 site (Liège, Liège) |
| Trial ID | NCT03901235 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of local injections of mesenchymal stromal cells (MSC) in patients with Crohn's disease who have refractory intestinal and perianal lesions. The study will include patients aged 18 and older who have had Crohn's disease for more than six months and have lesions that have not responded to conventional and biologic therapies. The trial will assess the healing of these lesions and monitor any potential safety concerns associated with the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults with Crohn's disease experiencing refractory lesions that have not responded to standard treatments.
Not a fit: Patients requiring immediate surgery or those with intestinal obstruction or intra-abdominal fistulas may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat Crohn's disease lesions.
How similar studies have performed: While the use of MSCs in treating Crohn's disease is an emerging area, similar approaches have shown promise in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Liège, Liège
- CHU de Liège — Liège, Liège, Belgium (Recruiting)
Study contacts
- Principal investigator: Edouard Louis, Prof — Centre Hospitalier Universitaire de Liege
- Study coordinator: Edouard Louis, Prof
- Email: edouard.louis@uliege.be
- Phone: 043667256
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.