Stem Cell Transplantation in Crohn's Disease

"Stem Cell Mobilization: Infused according to institutional guidelines;~Post-PBSC Infusion Conditioning: Mesna provided with Cytoxan according to institutional protocol."

"Stem Cell Mobilization:~Cyclophosphamide (CY) infused intravenously over 1 hour: 50 mg/kg (25 mg/kg/day on 2 consecutive days)"

"Stem Cell Mobilization: Filgrastim (G-CSF) 10 mcg/kg SC will start 5 days after the last dose of CY and will end the day before the last leukapheresis;~Post-PBSC Infusion Conditioning: Filgrastim administered intravenously 5 mcg/kg IV starting day + 5, continue until ANC of \>1000/μL"

Subjects will require placement of an Apheresis catheter by Intervention Radiologists on the day of collection of stem cells.

Leukapheresis will be performed on a continuous flow separator machine according to institutional guidelines to target 3-8 x 10\^6 CD34+ cells/kg body weight.

Preparative/Conditioning Regime Fludarabine given as 30 mg/m2 per dose x 4 days, beginning on day -6.

Preparative/Conditioning Regime r-ATG pre-medication according to institutional guidelines

Preparative/Conditioning Regime r-ATG premedication according to institutional guidelines

Preparative/Conditioning Regime r-ATG premedication according to institutional guidlines

Preparative/Conditioning Regime r-ATG administered intravenously: 2.5 mg/kg/dose IV over 6 hours on specified days (day -6,-4,-2); ); total 3 doses=7.5 mg/kg.

Preparative/Conditioning Regime In patients who develop severe allergic reactions to rATG (Thymoglobulin), it may be substituted by horse ATG (hATG, ATGAM, Pharmacia \& Upjohn, Kalamazoo, MI). The recommended dose of hATG is 25 mg/kg/day for 3 doses.

PBSC (peripheral blood stem cell) infusion on day 0 as per institutional guidelines.

Post-PBSC Infusion Conditioning Cytoxan infused intravenously: 50mg/kg/day x 2 days. Infused over 2 hours with adequate hydration or according to institutional guidelines.