NCT01769755 - 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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions

Crohns Disease

Interventions

BIOLOGICAL

PDA001

"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."

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."

Trial Locations (12)

14621

Rochester General Hospital, Rochester

23249

McGuire Veterans Affairs Medical Center, Richmond

32610

University of Florida, Gainesville

33136

University of Miami School of Medicine, Miami

37403

Erlanger Baroness Hospital, Chattanooga

44106

Case Western Reserve University Hospitals of Cleveland, Cleveland

45267

University of Cincinnati Medical Center, Cincinnati

77030

Baylor College of Medicine, Houston

84132

University of Utah, Salt Lake City

90048

Cedars Sinai Medical Center, Inflammatory Bowel Disease Center, Los Angeles

80220-3706

University of Colorado Health Science Center, Denver

37232-5505

Vanderbilt - Ingram Cancer Center, Nashville

All Listed Sponsors

lead

Celularity Incorporated

INDUSTRY