Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT01233960
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01233960
Study Brief:
Protocol Section:
NCT01233960