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Treatment of refractory Crohn's disease lesions by local injection of mesenchymal stem cells
EU CTIS ID: 2024-514033-37-00
What this study is testing
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
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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.
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.