Clinical Trial Goal
To find out if autologous BMT is safe and works well to treat Crohn’s disease
You may be able to join this trial if you:
- Are 18 years old or older
- Have Crohn’s disease that is active and has not gotten better with standard treatments
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
First, you'll get 2 drugs to prepare your body for apheresis:
- Cyclophosphamide – Given as an intravenous (IV) infusion
- Granulocyte colony-stimulating factor (G-CSF) – Given as a shot under the skin
Then, you’ll have apheresis, a process to collect, separate and save your blood-forming cells.
After that, you’ll get:
- Anti-thymocyte globulin (ATG) – Given as an IV infusion each day for 3 days
- Methylprednisolone – Given as an IV infusion or a pill that you take by mouth each day for 3 days
- Cyclophosphamide – Given as an IV infusion 1 time each day for 4 days
On transplant day, your own blood-forming cells are given back to you through an IV infusion.
After transplant, you’ll get vedolizumab, given as an IV infusion. You'll get the first dose of vedolizumab after you leave the hospital after transplant. Next, you’ll get another dose of vedolizumab after 2 weeks, then another after 1 month. After that, you'll get a dose every 2 months. You'll get a total of 8 doses of vedolizumab.
You'll have tests to see if your intestines are getting better. The clinical trial doctors will check your health for about 1 year after the transplant.
The Food and Drug Administration (FDA) has approved all the drugs used in this trial. The FDA has approved vedolizumab to treat Crohn’s disease. Treating Crohn’s disease with autologous BMT is new and unproven.
Contacts
Louis Cohen, MD, (212) 241-8100, louis.cohen@mssm.edu
Aaron Etra, MD, aaron.etra@mountsinai.org
Locations
Icahn School of Medicine at Mount SinaiRECRUITING
New York, New York
Jonathan Lagdameo, 212-241-8552, jonathan.lagdameo@mssm.edu
Sponsors
lead: Aaron Etra
