Mesenchymal Stem Cell Therapy for the Treatment of Severe or Refractory Inflammatory and/or Autoimmune Disorders

• Register: ClinicalTrials.gov
• Last refreshed on: 24 May 2021
• Main ID: NCT01540292
• Date of registration: 22/02/2012
• Prospective Registration: Yes
• Primary sponsor: University of Liege
• Public title: Mesenchymal Stem Cell Therapy for the Treatment of Severe or Refractory Inflammatory and/or Autoimmune Disorders
• Scientific title: Mesenchymal Stem Cell Therapy for the Treatment of Severe or Refractory Inflammatory and/or Autoimmune Disorders
• Date of first enrolment: February 1, 2013
• Target sample size: 13
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01540292
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Belgium

Contacts

• Name: Yves Beguin, MD, PhD
• Affiliation: CHU-ULg

• Name: Edouard Louis, MD, PhD
• Affiliation: CHU-ULg

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age between 18 and 75 years old

- Crohn's disease affecting terminal ileum, colon or both with diagnosis confirmed
according to Lennard Jones criteria

- Clinically active disease with a CDAI between 220 and 450 and biologically active
disease with a CRP > 5 mg/l and/or fecal calprotectin > 150 microg/g

- Resistance or intolerance to mesalazine, steroids, purine analogues, methotrexate,
infliximab and adalimumab

- Adequate venous access (central catheter or good peripheral veins)

- Willingness to sign the informed consent and enter the clinical trial

Exclusion Criteria:

- Any condition not fulfilling inclusion criteria

- Indication for surgery

- Symptomatic stricture

- Undrained perianal or intraabdominal abscess

- Change in mesalazine dosage within the last 4 weeks, change in steroid dosage within
the last two weeks, change in immunosuppressant dosage within the last 3 months, use
of anti-TNF treatment within the last two months

- HIV positive

- Uncontrolled infection, arrhythmia or hypertension

- Terminal organ failure:

- Renal: anuria, serious fluid overload, GFR < 30 ml/min, dialysis;

- Pulmonary: DLCO < 35% and/or receiving supplementary continuous oxygen;

- Hepatic: 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, and symptomatic
biliary disease;

- Cardiac: Symptomatic coronary artery disease or other cardiac failure requiring
therapy; ejection fraction < 35%; uncontrolled arrhythmia, uncontrolled
hypertension



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Biological: Mesenchymal Stem Cells (MSC)

Primary Outcome(s)

Clinical Response Rate [Time Frame: at week 8]

Secondary Outcome(s)

Crohn's Disease Activity Index Level [Time Frame: at week 2, 4, 8 and 12.]

Clinical Response [Time Frame: at week 2, 4, 8 and 12.]

Immune modulation investigation [Time Frame: at week 12.]

C-reactive Protein levels [Time Frame: at week 2, 4, 8 and 12.]

Fecal calprotectin levels [Time Frame: at week 2, 4, 8 and 12.]

Incidence of infections [Time Frame: by week 12]

Remission [Time Frame: at week 2, 4, 8 and 12.]

Secondary ID(s)

TJT1123

Source(s) of Monetary Support

Please refer to primary and secondary sponsors