Autologous Hematopoietic Stem Cell Transplantation for Crohn's Disease Treatment

Withdrawn before enrolling · Early Phase 1

Conditions studied: Crohn's Disease

In brief

The purpose of this study is to evaluate the safety and potential clinical benefit of lymphoablation followed by autologous HSCT rescue in therapy refractory Crohn's disease

Key facts

Study ID

NCT01932658

Run by

University of California, Los Angeles

People needed

0

Starts

2014-02-01

Expected to finish

2017-03-01

Last updated by the study team

2016-04-15

Who can join

Age: 7 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 7 and 50 years (patients aged 50 - 70 can participate up to the principal investigators discretion).
• Confirmed diagnosis of active Crohn's disease:
• Diagnosis of Crohn's disease based on typical radiological appearances and or typical histology at least 6 months prior to screening.
• Active disease at the time of registration to the trial, defined as
• i)Crohn's Disease Activity Index (CDAI) > 250, and ii)Two of the following:
• elevated C-Reactive Protein (CRP)
• endoscopic evidence of active disease confirmed by histology
• clear evidence of active small bowel Crohn's disease on Computed tomography (CT) or Magnetic Resonance (MR) enterography.
• Unsatisfactory course despite 3 immunosuppressive agents (usually azathioprine, methotrexate and infliximab, adalimumab and/or certolizumab) in addition to corticosteroids. Patients should have relapsing disease (i.e. 1 exacerbation/year) 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:
• Prepared to undergo additional study procedures as per trial schedule
• Patient has undergone intensive counseling about risks

You may not qualify if…

• 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
• renal: creatinine clearance < 30 mL/min (measured or estimated)
• cardiac: clinical evidence of refractory congestive heart failure; left ventricular ejection fraction < 40% by multigated radionuclide angiography (MUGA) or cardiac echo; chronic atrial fibrillation necessitating oral anticoagulation; uncontrolled ventricular arrhythmia; pericardial effusion with hemodynamic consequences as evaluated by an experienced echo cardiographer.
• pulmonary: diffusion capacity <40%
• psychiatric disorders including active drug or alcohol abuse
• concurrent or recent history of malignant disease (excluding non-melanoma skin cancer)
• uncontrolled hypertension, defined as resting systolic blood pressure ≥ 140 and/or resting diastolic pressure ≥ 90 despite at least 2 anti-hypertensive agents.
• uncontrolled acute or chronic infection with HIV, Human T-Lymphotropic virus (HTLV-1 or 2), hepatitis viruses or any other infection the investigators consider a contraindication to participation.
• other chronic disease causing significant organ failure.
• Infection or risk thereof:
• Current clinical relevant abscess or significant active infection.
• Perianal fistula without free drainage. Perianal fistulas is not an exclusion provided there is natural free drainage or a seton suture(s)have been placed.
• History of tuberculosis or currently at risk for tuberculosis
• Quantiferon Gold test result or other investigations that the investigators regard as evidence of active tuberculosis.
• Abnormal chest X-ray (CXR) consistent with active infection or neoplasm.
• Significant malnutrition: Body Mass Index (BMI) ≤ 18, serum albumin < 20g/l.
• Previous poor compliance.
• Concurrent enrollment in any other protocol using an investigational drug or hematopoietic growth factor up to four weeks before study entry.

Where it is running

• UCLA Center for Inflammatory Bowel Diseases — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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