Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease

• Disease Improvement [ Time Frame: 180 Days after first infusion in Protocol 603 ] [ Designated as safety issue: No ]
  CDAI response to treatments is defined as a CDAI of 150 or below, or a reduction in CDAI of at least 100 points.
• Improvement in Quality of Life (IBDQ) [ Time Frame: 180 Days after first infusion in Protocol 603 ] [ Designated as safety issue: No ]
  IBDQ response to treatment is defined as IBDQ of 170 or above, or an increase in IBDQ of at least 16 points.
• Number of Adverse events as a measure of safety [ Time Frame: 180 Days after first infusion in Protocol 603 ] [ Designated as safety issue: Yes ]
• Infusional toxicity as a measure of safety and tolerability [ Time Frame: 180 Days after first infusion in Protocol 603 ] [ Designated as safety issue: Yes ]
  Infusional toxicity will be evaluated by continuously monitoring the subject's vital signs and O2 saturation by pulse oximetry from the time of PROCHYMAL administration until two hours after infusion is complete.

To provide open-label re-treatment with PROCHYMAL to subjects enrolled in companion Protocol 603 to evaluate the safety in subjects with active Crohn's disease who are resistant to standard Crohn's disease therapies.

Subjects will receive infusions of PROCHYMAL on Day 42, Day 84, and Day 126 after initial infusion of PROCHYMAL in Protocol 603. Each infusion will contain 200 million cells. As subjects will be required to be in Protocol 603 during the entire duration of their participation in Protocol 611, all concomitant medication and safety information will be monitored by Protocol 603 and the combination of data from the two protocols

Inclusion Criteria:

• Subject must have qualified for, enrolled in, and provided written ICF and authorization for use and disclosure of PHI for Protocol 603 after the August 3, 2010.
• Subject successfully completed all screening assessments in Protocol 603 as required by Protocol 603.
• Subject successfully completed the full course of each of the four infusions of investigational agent on Days 0, 3, 7, and 14 of Protocol 603 after August 3, 2010.
• Subject must enroll in Protocol 611 on or before the 45th day after first infusion in Protocol 603.
• Subject must provide written ICF and authorization for use and disclosure of PHI for Protocol 611.

Exclusion Criteria:

• Subject is unwilling or unable to adhere to requirements of Protocol 611.
• Subject had confirmed respiratory distress during a PROCHYMAL infusion in any prior PROCHYMAL study.
• Subject had a serious adverse event in any previous PROCHYMAL study that was deemed by the principal investigator of that study to be possibly or probably related to PROCHYMAL and also that was within 48 h after a PROCHYMAL infusion.