To provide open-label re-treatment with PROCHYMAL to participants enrolled in companion Protocol 603 to evaluate the safety in participants with active Crohn's disease who are resistant to standard Crohn's disease therapies.
Participants 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 participants 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
73
PROCHYMAL will be administered IV in a total volume of 300 ml (200 million cells) at a rate of 4-6 ml/minute. Treatments will be administered on Days 42-45, Days 84-87, and Days 126-129 following first infusion in Protocol 603.
University of California, San Francisco
San Francisco, California, United States
Clinical Research of West Florida
Disease remission
Crohn's Disease Activity Index (CDAI) at or below 150 and increase in IBDQ
Time frame: 180 Days after first infusion in Protocol 603
Disease Improvement
CDAI response to treatments is defined as a CDAI of 150 or below, or a reduction in CDAI of at least 100 points.
Time frame: 180 Days after first infusion in Protocol 603
Improvement in Quality of Life (IBDQ)
IBDQ response to treatment is defined as IBDQ of 170 or above, or an increase in IBDQ of at least 16 points.
Time frame: 180 Days after first infusion in Protocol 603
Number of Adverse events as a measure of safety
Time frame: 180 Days after first infusion in Protocol 603
Infusional toxicity as a measure of safety and tolerability
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.
Time frame: 180 Days after first infusion in Protocol 603
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