Crohn's Disease
Conditions
Keywords
Crohn's Disease, Adult Stem Cell Therapy, inflammation of the gastrointestinal tract
Brief summary
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.
Detailed description
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.
Interventions
DRUGProchymal®
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.
Sponsors
Mesoblast, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Participant must have qualified for, enrolled in, and provided written informed consent form (ICF) and authorization for use and disclosure of protected health information (PHI) for Protocol 603 after the August 3, 2010. * Participant successfully completed all screening assessments in Protocol 603 as required by Protocol 603. * Participant 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. * Participant must enroll in Protocol 611 on or before the 45th day after first infusion in Protocol 603. * Participant must provide written ICF and authorization for use and disclosure of PHI for Protocol 611.
Exclusion criteria
* Participant is unwilling or unable to adhere to requirements of Protocol 611. * Participant had confirmed respiratory distress during a PROCHYMAL infusion in any prior PROCHYMAL study. * Participant 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease remission | 180 Days after first infusion in Protocol 603 | Crohn's Disease Activity Index (CDAI) at or below 150 and increase in IBDQ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Improvement | 180 Days after first infusion in Protocol 603 | 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) | 180 Days after first infusion in Protocol 603 | 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 | 180 Days after first infusion in Protocol 603 | — |
| Infusional toxicity as a measure of safety and tolerability | 180 Days after first infusion in Protocol 603 | 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. |
Countries
Australia, New Zealand, United States
Contacts
STUDY_DIRECTORChristopher James, PA
Mesoblast, Inc.
Outcome results
None listed