UnknownNot Applicable

Autologous Unselected Hematopoietic Stem Cell Transplantation for Refractory Crohn's Disease

Brazil50 participantsStarted 2013-10

Plain-language summary

This study evaluates the safety and clinical benefits of a therapeutic approach using the cyclophosphamide (Cy) + thymoglobulin® (ATG) + granulocyte colony-stimulating factor (G-CSF) conditioning regimen followed by autologous hematopoietic stem cell transplantation (HSCT) rescue in the treatment of refractory Crohn's disease. Adverse events, and clinical and endoscopic conditions will be assessed at different short and long-term time points.

Who can participate

Age range14 Years – 70 Years

SexALL

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Inclusion criteria

✓. Age between 14 and 50 years (patients aged 50 - 70 can participate at the principal investigators discretion).
✓. Confirmed diagnosis of active Crohn's disease:
✓. Unsatisfactory course despite immunosuppressive agents (usually azathioprine, methotrexate and two biologic agents (normally infliximab, adalimumab and/or certolizumab) in addition to corticosteroids. Patients should have relapsing and refractory disease despite thiopurines, methotrexate and/or infliximab/adalimumab/certolizumab maintenance therapy or clear demonstration of intolerance / toxicity to these drugs.
✓. Current problems unsuitable for surgery or patient at risk for developing short bowel syndrome.
✓. Informed consent:

Exclusion criteria

✕. Pregnancy or unwillingness to use adequate contraception during the study, in women of childbearing age. Unwillingness of using appropriate contraceptive measures in males.
✕. Concomitant severe disease

What they're measuring

Safety of unselected autologous HSCT in refractory Crohn´s disease patients

Timeframe: 12 months

Trial details

NCT IDNCT03000296

SponsorBeneficência Portuguesa de São Paulo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12

View on ClinicalTrials.gov More Crohn's Disease trials