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New treatment option for Crohn Disease
Official title Stem Cell Transplantation in Crohn's Disease
ClinicalTrials.gov ID: NCT04224558
What this study is testing
What is Mesna?
Mesna is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for crohn disease.
Also referred to as Mesnex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Unfortunately, some patients with Crohn's disease (CD) fail to respond to the best clinical treatments and some only experience temporary benefit. For severe Crohn's disease, there is an experimental treatment called "high dose immunoablation" followed by autologous hematopoietic stem cell transplantation (HSCT).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 28
You may be able to join if
- Aged 13-28 years are eligible
- 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) PCDAI \> 30, and ii) Two of the following:
- elevated CRP
You likely can't join if
- Pregnancy or unwillingness to use adequate contraception during the study, in women of childbearing age. Unwillingness of using appropriate...
- 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 cardiac echo; chronic atrial...
- pulmonary: diffusion capacity \<40%
- psychiatric disorders including active drug or alcohol abuse
See the full eligibility criteria
- Aged 13-28 years are eligible
- 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) PCDAI \> 30, and ii) Two of the following:
- elevated CRP
- endoscopic evidence of active disease confirmed by histology
- clear evidence of active small bowel Crohn's disease on CT or 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...
- Current problems unsuitable for surgery or patient at risk for developing short bowel syndrome.
- Accepted by a majority of the members of the combined IBD Center as an appropriate candidate (see Selection description below).
- Informed consent
- Prepared to undergo additional study procedures as per trial schedule
- Patient has undergone intensive counseling about risks
- 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 cardiac echo; chronic atrial fibrillation necessitating oral anticoagulation; uncontrolled ventricular...
- 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.
- any infection with HIV, 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 at current increased risk of 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. 6) Significant malnutrition: Body Mass Index (BMI) ≤ 18, serum albumin \< 20 g/l. 7) Previous poor compliance. 8) Concurrent enrollment in any...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 28 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.