Autologous stem cell transplantation for the treatment of refractory Crohn*s disease: mechanisms of succes

Recruiting

• Conditions: granulomatous enteritis; Inflammatory bowel disease; 10017969

• Registration Number: NL-OMON39547
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1) Age between 18 and 65 years
2) Confirmed diagnosis of active Crohn*s Disease:
3) Active disease at the time of registration to the trial
4) Unsatisfactory course despite 3 immunosuppressive agents (usually azathioprine, methotrexate and infliximab or adalimumab) in addition to corticosteroids. Patients should have relapsing disease (i.e. >1 exacerbation/year) despite thiopurines, methotrexate and/or infliximab/adalimumab maintenance therapy or clear demonstration of intolerance / toxicity to these drugs.
4) Current problems unsuitable for surgery or patient is at risk for developing short bowel syndrome.

Exclusion Criteria

1) Pregnancy or unwillingness to use adequate contraception during the treatement, if a woman of childbearing age
2) Concomitant severe disease
a) renal: creatinine clearance < 40 ml/min (measured or estimated)
b) cardiac: clinical evidence of refractory congestive heart failure
c) psychiatric disorders including active drug or alcohol abuse
d) concurrent or recent history of malignant disease (excl. non-melanoma skin cancer)
e) uncontrolled hypertension, defined as resting systolic blood pressure >= 140 and/or resting diastolic pressure >= 90 despite at least 2 anti-hypertensive agents.
f) uncontrolled acute or chronic infection with HIV, HTLV-1 or 2, hepatitis viruses or any other infection the investigators consider a contraindication to participation.
g) other chronic disease causing significant organ failure, including established cirrhosis with evidence of impaired synthetic function on biochemical testing and known severe respiratory disease.
h) Crohn*s Disease symptoms predominantly due to fibrotic stricturing and unlikely to respond to immune manipulation.
3) Infection or risk thereof
a) History of tuberculosis or at current increased risk of tuberculosis
b) Mantoux test result or other investigations that the investigator as evidence of active tuberculosis.
c) Abnormal chest x ray (CXR) consistent with active infection or neoplasm.
4) Previous poor compliance
5) Concurrent enrolment in any other protocol using an investigational drug or hematopoietic growth factor up to four weeks before study entry.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To investigate on the cost effectivity and the immunological mechanisms<br /><br>involved in immune reconstitution and engraftment after ASCT in Crohn's disease<br /><br>patients. To gain insight in the effect of ASCT on the microbiome </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>