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

Mesoblast

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Drug: adult human mesenchymal stem cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT01233960

CRD 611

Details and patient eligibility

About

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.

Full description

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

Enrollment: 73 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject 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.
• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 1 patient group

Prochymal

Experimental group

Description:

Infusions of Prochymal on days 42-45, 84-87, and 126-129 after first infusion in Protocol 603. Each infusion of PROCHYMAL (remestemcel-L) will contain 200 million cells.

Treatment:

Drug: adult human mesenchymal stem cells