Is local injection of mesenchymal stem cells after endoscopic dilation safe and does it improve the outcome of intestinal stricture in patients with Crohn's disease?

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre hospitalier universitaire de Liege

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

20 May 2026 → ongoing

Decision date (initial)

2024-09-26

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-511034-12-00

EudraCT number

2022-003833-21

ClinicalTrials.gov

NCT06317818

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

Assess the safety and efficacy of local Mesenchymal Stem Cells injection, in association with endoscopic dilation, in the strictures of patients with Crohn's Disease.

Secondary objectives 2

1. Identify the predictive factors of clinical response to the combined treatment of local Mesenchymal Stem Cells injection, in association with endoscopic dilation.
2. Evaluate the histological modifications of the proteome of the intestinal epithelium, of the adherent intestinal microbiota, the serum/plasma proteomic profile and the blood immunophenotyping, induced by these Mesenchymal Stem Cells, to better understand the specific mechanisms of action of this treatment.

Conditions and MedDRA coding

Crohn's disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patient aged ≥ 18 years with Crohn's Disease diagnosed more than 6 months ago
2. Background Crohn's Disease treatment stable for 4 months
3. Presence of stricture (whether de novo or anastomotic), meeting the radiological definition of stenosis, i.e. a combination of the following criteria: (1) localized luminal narrowing (reduction of luminal diameter by at least less than 50% compared to adjacent healthy bowel segment), (2) bowel wall thickening (25% increase in wall thickness compared to adjacent unaffected bowel) and pre-stenotic dilation (luminal diameter greater than 3 cm)
4. Presence of symptomatic stricture with abdominal pain after meals and limitations on the amount or type of food at screening
5. Presence of a stenosis accessible by ileo-colonoscopy, not passable (i.e. not allowing the passage of the adult ileo-colonoscope), of a length less than 5 cm, eligible for endoscopic dilation
6. Patient accepting the study protocol and having signed an informed consent
7. Patient capable of undergoing a Magnetic Resonance Enterography with Dynamic-Contrast-Enhancement (DCE-MRI)

Exclusion criteria 11

1. Patient liable for immediate surgery
2. Patient with intra-abdominal fistula or abscess
3. Patient with a stenosis not accessible to ileo-colonoscopy
4. Patient presenting ≥ 2 strictures with impossibility of determining which stenosis is "dominant" and responsible for the symptoms (based on dilation at Magnetic Resonance Enterography)
5. Patient with stricture longer than 5 cm
6. Patient with a contraindication to performing a Magnetic Resonance Enterography (MRE) or to the use of contrast product injection in MRE (Gadolinium)
7. Pregnant woman or planning a pregnancy in the year
8. Patient with kidney insufficiency (with anuria, GFR or glomerular filtration rate < 30 ml/min or on dialysis), hepatic insufficiency (presence of fulminant hepatitis, cirrhosis with signs of portal hypertension, acute alcoholic hepatitis, esophageal varices, history of gastrointestinal bleeding following rupture of esophageal varices, hepatic encephalopathy, prolonged prothrombin time, ascite secondary to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with a total serum bilirubin level > 3 mg/dL)
9. Patient with documented human immunodeficiency virus (HIV) infection, active hepatitis B or C, or tuberculosis
10. Patient having presented an opportunistic infection in the 6 months preceding inclusion or a serious infection in the previous 3 months
11. Patient who has developed a malignant tumor with a history of lymphoproliferative disease with the exception of: non-melanoma skin cancer, carcinoma in situ (e.g. skin, cervix, bladder, breast) and in remission for at least 3 years prior to screening, superficial bladder cancer, asymptomatic low-grade or localized curatively treated prostate cancer for which the “watch-and-wait” approach is the standard of care as well as any other cancer that has been in remission for ≥ 3 years prior to enlistment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. The occurrence of adverse events (serious or not) up to week 48 for safety evaluation
2. A clinical response to symptomatic stricture WITH either an endoscopic response or a radiological response AND the absence of recourse to endoscopic dilation, surgery, corticosteroid therapy or therapeutic optimization of anti-inflammatory treatment currently used for Crohn's Disease at the time of the procedure, for efficacy, for primary efficacy evaluation

Secondary endpoints 1

1. Evolution of Patient Reported Outcomes (PROs) and Stenosis Patient Reported Outcomes (S-PROs) between weeks 0, 24 and 48, as well as the evolution of endoscopic and radiological parameters (measured by DCE-MRI) between weeks 0, 24 and 48, for secondary efficacy evaluation.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre hospitalier universitaire de Liege

Sponsor organisation

Centre hospitalier universitaire de Liege

Address

Avenue De L'hopital 1

City

Liege

Postcode

4000

Country

Belgium

Scientific contact point

Organisation

Centre hospitalier universitaire de Liege

Contact name

Prof. Edouard Louis

Public contact point

Organisation

Centre hospitalier universitaire de Liege

Contact name

Prof. Edouard Louis

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications