NCT01540292

Brief Summary

This project aims to assess safety and efficacy of allogeneic Mesenchymal stem Cell (MSC) in Crohn's disease refractory or intolerant to conventional therapies. Twenty patients with active refractory Crohn's disease defined by a Crohn's Disease Activity Index (CDAI) \> 220 despite conventional treatment will be included over 4 years in this phase I-II trial. This will be a pilot open label trial. Patients will be treated with 2 successive injections of allogeneic MSC at baseline and 4 weeks later. Patients will be followed up at weeks 2, 4, 8 and 12.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2013

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2012

Completed
11 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

2.9 years

First QC Date

February 22, 2012

Last Update Submit

May 11, 2021

Conditions

Crohn's Disease

Keywords

Crohn's diseaseMesenchymal Stem CellCell therapyAllogeneicInflammatory disordersAutoimmune disorders

Outcome Measures

Primary Outcomes (1)

  • Clinical Response Rate

    To assess clinical response rate defined by a 100 points decrease in Crohn's Disease Activity Index.

    at week 8

Secondary Outcomes (7)

  • Clinical Response

    at week 2, 4, 8 and 12.

  • Remission

    at week 2, 4, 8 and 12.

  • Crohn's Disease Activity Index Level

    at week 2, 4, 8 and 12.

  • C-reactive Protein levels

    at week 2, 4, 8 and 12.

  • Fecal calprotectin levels

    at week 2, 4, 8 and 12.

  • +2 more secondary outcomes

Study Arms (1)

MSC

EXPERIMENTAL

Patients with Crohn's disease (refractory or intolerant to conventional therapies) treated with 2 successive injections of 1.5-2.0 x 10E6 allogenic MSC/kg BW at baseline and 4 weeks later.

Biological: Mesenchymal Stem Cells (MSC)

Interventions

Mesenchymal Stem Cells (MSC)BIOLOGICAL

MSC (1.5-2 cells/kg BW) IV injection, twice at 4 weeks apart

MSC

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Liège

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Crohn DiseaseAutoimmune Diseases

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesImmune System Diseases

Study Officials

  • Yves Beguin, MD, PhD

    CHU-ULg

    STUDY CHAIR

  • Edouard Louis, MD, PhD

    CHU-ULg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 22, 2012

First Posted

February 28, 2012

Study Start

February 1, 2013

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

May 12, 2021

Record last verified: 2021-05

Locations

BE(1)