Actively Recruiting
MSC Intratissular Injection in Crohn Disease Patients
Led by University of Liege · Updated on 2024-12-12
60
Participants Needed
1
Research Sites
467 weeks
Total Duration
On this page
Sponsors
U
University of Liege
Lead Sponsor
C
Centre Hospitalier Universitaire de Liege
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MSC Intratissular Injection in Crohn Disease Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Signed 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 biologic treatments (anti-TNF therapies, vedolizumab, or ustekinumab)
- Refractory lesion defined as (1) a 2 to 5 cm colon or ileum stricture accessible by ileocolonoscopy, (2) an unhealed deep ulcer of the colon or ileum accessible by ileocolonoscopy, or (3) actively draining perianal fistula(s)
- Enrollment of 20 patients with strictures, 20 with unhealed deep ulcers, and 20 with actively draining perianal fistulas
You will not qualify if you...
- Need for immediate luminal surgery
- Intestinal obstruction
- Presence of intra-abdominal fistulas or abscess
- Intestinal or colonic stricture or deep unhealed ulcer not accessible by ileocolonoscopy
- Undrained perianal abscess
- Pregnancy or planned pregnancy within one year
- Positive stool culture or toxin for Clostridium difficile or other pathogens
- Renal failure (anuria, serious fluid overload, GFR <30 ml/min, or dialysis) or severe hepatic failure
- Documented HIV infection; active hepatitis B, C, or tuberculosis
- Opportunistic infection within 6 months before screening or serious infection within 3 months
- Malignancy within the past 5 years or history of lymphoproliferative disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHU de Liège
Liège, Liège, Belgium, 4000
Actively Recruiting
Research Team
E
Edouard Louis, Prof
CONTACT
C
Chantal Lechanteur
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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