Autologous Stem Cell Transplant for Crohn's Disease
Status:
Recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
Summary
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
other drugs to improve the chances of achieving remission and also maintaining the remission.
The Investigators' plan in this study is to incorporate the drug Vedolizumab after transplant
to test if this drug will improve remission and make patients healthier.
Patients may qualify to take part in this research study because Crohn's disease is active,
because surgery is not a treatment option and because there is evidence that the disease has
failed to respond to treatments for Crohn's disease including the following:
- corticosteroids
- azathioprine, 6-mercaptopurine, methotrexate
- Anti-TNFα (infliximab, adalimumab, certolizumab, golimumab)
- Anti-integrin agents (natalizumab, Vedolizumab) If patients meet entry criteria will
undergo a baseline endoscopy, colonoscopy and MR or CT enterography. If documentation of
active mucosal disease patients will then be tapered off of current medications and
undergo stem cell mobilization. Mobilization will involve low dose chemotherapy, growth
factors and require 1-2 week hospitalization. Patients will then undergo stem cell
transplant which will involve high dose chemotherapy and require a 2-4 week
hospitalization. After restoration of the immune system patients will be placed on
vedolizumab per standard dosing (0,2,6 then 8 every weeks) for a total of 8 doses.
Patients will have monthly study visits and a repeat colonoscopy and MR/CT scan at 6
months.