Clinical trial for Crohn Disease
Official title Stem Cell Transplantation in Crohn's Disease
ClinicalTrials.gov ID: NCT04224558
What this study is testing
What is Mesna?
An investigational medicine being studied as part of a conditioning regimen for severe Crohn's disease. is designed to protect healthy tissues from damage caused by the chemotherapy drug Cytoxan.
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
- This study is testing whether a stem cell transplant can reset the immune system. It aims to help the body fight Crohn's disease better.
- Who it's for
- You may be able to join if you have severe Crohn's disease that does not respond to standard treatments.
- What's involved
- You would get a high dose of medicine to calm your immune system. Then, you would receive stem cells from your own blood.
- Time commitment
- The source text does not specify the total study length or required visits.
- 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
- Diagnosis of Crohn's disease based on typical radiological appearances and / or typical histology at least 6 months prior to screening.
- elevated CRP
- endoscopic evidence of active disease confirmed by histology
- clear evidence of active small bowel Crohn's disease on CT or MR enterography.
You likely can't join if
- Pregnancy or unwillingness to use adequate contraception during the study, in women of childbearing age.
- 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
- pulmonary: diffusion capacity \<40%
- psychiatric disorders including active drug or alcohol abuse
See the full eligibility criteria
- Aged 13-28 years are eligible
- Diagnosis of Crohn's disease based on typical radiological appearances and / or typical histology at least 6 months prior to screening.
- 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.
- 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
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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?
This study is enrolling now at Los Angeles, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.