๐ฌIn plain words
What the trial is, and whether it could suit you
Crohn's Disease (CD) is an inflammatory bowel disease. It can lead to significant complications and discomfort in the stomach and intestines. Crohn's disease is a debilitating, incurable disease of immune cells; it affects almost 1 million people in the United States. CD is characterized by inflammation of the stomach and intestine as well as organs outside of the intestines such as the skin, eyes, and joints. Current therapies to treat CD aim to suppress the patient's immune cells but these therapies become ineffective for the majority of patients and lead to complications including the requirement for surgical bowel resection, impaired quality of life, and lifelong disability. Hematopoietic stem cell transplantation (HCT) is a procedure used to treat a number of medical conditions including Crohn's disease. To improve success of HCT in CD doctors considered combining transplant with ot
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Diagnosis of Crohn's disease by standard criteria
* Active disease based on clinical symptoms, defined as CDAI \>250. In patients with an ostomy, the number of liquid stools score in the CDAI will be replaced by the number of times that the ostomy bag is emptied daily.
* Active disease based on endoscopic evaluation, defined as SES-CD score \> 3 in at least one bowel segment
* Failure to respond to (or intolerant/adverse reaction to or declines) a member of each of the class of drugs listed below:
1. corticosteroids
2. azathioprine,
3. 6-mercaptopurine, methotrexate
4. Anti-TNFฮฑ (infliximab, adalimumab, certolizumab, golimumab)
5. Anti-integrin agents (natalizumab, vedolizumab)
6. Ustekinumab
* Failure to respond refers to ongoing objective inflammation with symptoms and, as is traditional, is defined by the gastroenterologist evaluating the patient.
* No surgical therapeutic option secondary to risk of short bowel syndrome or patient refusal
Exclusion Criteria:
* History of significant toxicity to any medications used in trial (cyclophosphamide, thymoglobulin, vedolizumab)
* Pregnant or breastfeeding
* Age \<18
* Karnofsky Performance Score \<60
* Patients who have an uncontrolled infection (presumed or documented) despite appropriate therapy for at least one month
* Patients with symptomatic coronary artery disease or uncontrolled congestive heart failure.
* HIV infected
* Ejection fraction \<30% or requiring supplemental continuous oxygen.
* DLCO \<35% or requiring supplementary oxygen.
* Patients for whom an insufficient number of stem cells (\<2 X 10\^6/kg) have been collected.
๐
What it tests
- Autologous stem cell transplant
- Cyclophosphamide
- Cyclophosphamide
- Thymoglobulin
- Methylprednisolone
Icahn School of Medicine at Mount Sinai
New York, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.