A Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Determine the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Crohn's Disease
To assess the safety and efficacy of intravenous (IV) PDA001 infused every two weeks for up to 5 total infusions in subjects with Crohn's disease who are refractory to one or more standard Crohn's disease therapies.
Drug: Vehicle Controlled Placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Determine the Safety and Efficacy of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Crohn's Disease|
- Adverse Events [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]Number of participants experiencing adverse events during the initial and extended follow-up periods
- Efficacy [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]To evaluate the time course of clinical efficacy of ascending doses of IV PDA001 versus placebo infused every other week for 8 weeks (5 total infusions) as measured by the Crohn's Disease Activity Index (CDAI) at each scheduled visit
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Experimental: Human Placenta-Derived Cells PDA001 Intravenous Infusion
Intravenous infusion of Human Placenta-Derived Cells PDA001 over the course of 2 hours.
Cohort 1 Dose Level 1: ¼ unit Human Placenta-Derived Cells PDA001 infused a total of 5 times 2 weeks apart.
Cohort 2 Dose Level 2: ½ unit Human Placenta-Derived Cells PDA001 infused a total of 5 times 2 weeks apart.
Cohort 3 Dose Level 3: 1 unit Human Placenta-Derived Cells PDA001 infused a total of 5 times 2 weeks apart.
Placebo Comparator: Vehicle controlled placebo
Intravenous infusion of Vehicle Controlled Placebo over the course of 2 hours
Drug: Vehicle Controlled Placebo
Cohort 1 Dose Level 1: ¼ unit vehicle controlled placebo infused a total of 5 times 2 weeks apart.
Cohort 2 Dose Level 2: ½ unit vehicle controlled placebo infused a total of 5 times 2 weeks apart.
Cohort 3 Dose Level 3: 1 unit vehicle controlled placebo infused a total of 5 times 2 weeks apart.
This is a randomized, double-blind, placebo-controlled, dose-escalation study to study 3 cohorts of subjects with Crohn's Disease with colonic involvement. Each cohort (n = 9) will include PDA001 treated subjects (n = 6) as well as placebo (vehicle control) treated subjects (n = 3). Cohorts will be enrolled sequentially, beginning with the lowest dose cohort (1/4 unit PDA001) and progressing until the maximum tolerated dose of IV PDA001 is determined.
|Contact: Associate Director Clinical Trial Disclosureemail@example.com|
|Contact: Lynn Ann O'Connellfirstname.lastname@example.org|
|United States, California|
|Cedars Sinai Medical Center||Recruiting|
|Los Angeles, California, United States, 90048|
|United States, Colorado|
|University of Colorado Hospital||Recruiting|
|Aurora, Colorado, United States, 80045|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32608|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|United States, New York|
|Rochester General Hospital||Recruiting|
|Rochester, New York, United States, 14621|
|United States, Ohio|
|University of Cincinnati||Recruiting|
|Cincinnati, Ohio, United States, 45267|
|Case Western University||Recruiting|
|Cleveland, Ohio, United States, 44106|
|United States, Tennessee|
|Erlanger Medical Center||Recruiting|
|Chattanooga, Tennessee, United States, 37403|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|United States, Utah|
|University of Utah||Recruiting|
|Salt Lake City, Utah, United States, 84132|
|United States, Virginia|
|McGuire VA Medical Center||Recruiting|
|Richmond, Virginia, United States, 23249|
|Study Director:||Steven Fischkoff, MD||Celgene Corporation|