Maintenance in Autologous Stem Cell Transplant for Crohn’s Disease (MASCT - CD)
ID Number 17-0378Principal Investigator(s)
Amir S Steinberg
Louis J Cohen
Department(s) or Division(s)
Hematology and Medical Oncology
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 the body's 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. Our 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 their Crohn's disease is active, because surgery is not a treatment option for them, and because there is evidence that their disease has failed to respond to treatments for Crohn's disease including the following:
- Azathioprine, 6-mercaptopurine, methotrexate
- Anti-TNFa (infliximab, adalimumab, certolizumab, golimumab)
- Anti-integrin agents (natalizumab, Vedolizumab)
Recruiting Patients: Yes