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

PHASE3CompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

November 29, 2010

Primary Completion Date

September 15, 2014

Study Completion Date

September 15, 2014

Conditions
Crohn's Disease
Interventions
DRUG

adult human mesenchymal stem cells

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.

Trial Locations (20)

10028

Weill Cornell Medical College, New York

10029

Mount Sinai School of Medicine, New York

20815

Chevy Chase Clinical Research, Chevy Chase

21201

University of Maryland, Baltimore, Baltimore

23249

McGuire Research Institute, Richmond

32789

Shafran Gastroenterology Center, Winter Park

33765

Clinical Research of West Florida, Clearwater

37232

Vanderbilt University Medical Center, Nashville

38138

Gastroenterology Center of the Midsouth, PC, Germantown

60611

University of Chicago, Chicago

63128

Saint Louis Center for Clinical Research, St Louis

St. Louis Center for Clinical Studies, St Louis

66606

Cotton-O'Neil Clinical Research Center, Topeka

75246

Baylor University Medical Center, Dallas

94115

University of California, San Francisco, San Francisco

03756

Dartmouth HItchcock Medical Center, Lebanon

Unknown

Royal Adelaide Hospital, Adelaide

Royal Melbourne Hospital, Melbourne

University of Otago, Christchurch

Waikato Hospital, Hamilton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mesoblast, Inc.

INDUSTRY