Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD)

PHASE3CompletedINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

August 17, 2006

Primary Completion Date

December 26, 2008

Study Completion Date

May 28, 2009

Conditions
Graft Versus Host Disease
Interventions
BIOLOGICAL

Prochymal®

2 infusions of 2 million cells/kg per week for 4 weeks

DRUG

Placebo

2 infusions per week for 4 weeks

DRUG

Standard of Care for GVHD

Institutionally defined standard of care (e.g., maintenance of steroid treatment and the addition of a second-line therapy)

Trial Locations (70)

3050

Royal Melbourne Hospital, Parkville

4029

Royal Brisbane Hospital, Herston

4031

Kantonsspital Basel, Basel

6100

Royal Perth Hospital, Perth

10021

New York Presbyterian Hospital, New York

10029

Mount Sinai Medical Center, New York

10032

Columbia University/New York Presbyterian Hospital, New York

10595

New York Medical College, Valhalla

14263

Roswell Park, Buffalo

14642

University of Rochester, Rochester

15224

Western Pennsylvania Cancer Institute, Pittsburgh

17033

Penn State Hershey Medical Center, Hershey

21201

University of Maryland/Greenbaum, Baltimore

23298

Virginia Commonwealth/Massey Cancer Center, Richmond

27100

IRCCS Policlinico San Matteo, Pavia

27157

Wake Forest Univeristy School of Medicine, Winston-Salem

27710

Duke University, Durham

29425

Medical University of South Carolina, Charleston

30322

Emory University, Atlanta

30342

Northside Hospital, Atlanta

33136

University of Miami, Miami

33701

All Children's Hospital, St. Petersburg

35249

University of Alabama at Birmingham, Birmingham

39216

Univeristy of Mississippi Medical Center, Jackson

40202

University of Louisville, Louisville

46107

Indiana Blood and Bone Marrow Transplant Center, Beech Grove

48201

Karmanos/Wayne State University, Detroit

52242

Univeristy of Iowa Hospitals and Clinics, Iowa City

53226

Medical College of Wisconsin, Milwaukee

53792

University of Wisconsin Madison, Madison

55905

Mayo Clinic Rochester, Rochester

60611

Northwestern Center for Clinical Research, Chicago

60612

Rush University Medical Center, Chicago

University of Illinois - Chicago, Chicago

61100

Universia degli Studi di Pesaro, Pesaro

66160

University of Kansas Medical Center, Kansas City

68198

University of Nebraska, Omaha

71130

Louisiana State University, Shreveport

75230

Texas Cancer Center at Medical City, Dallas

75246

Baylor University, Dallas

75390

Univeristy of Texas Southwestern Medical Center, Dallas

77030

MD Anderson Cancer Center, Houston

78229

Texas Research Center, San Antonio

85724

Arizona Cancer Center, Tucson

91010

City of Hope, Duarte

94143

Univeristy of California San Francisco, San Francisco

97239

Oregon Health and Science University, Portland

06520

Yale New Haven Hospital, New Haven

02111

Tufts-New England Medical Center, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Dana-Farber Cancer Institute, Boston

07601

Hackensack University Medical Center, Hackensack

98109-1024

Fred Hutchinson Cancer Research Center, Seattle

T1Y6J4

Co-Medica Research Network, Calgary

V6H3V4

British Columbia's Children's Hospital, Vancouver

R3E0V9

Cancer Care Manitoba, Winnipeg

B3H2Y9

Queen Elizabeth II Health Sciences Centre, Halifax

L8N3Z5

Hamilton Health Sciences Centre, Hamilton

N6A4G5

London Health Sciences Centre- Westminster Campus, London

K1H8L6

Ottawa Hospital, Ottawa

M5G 1X8

Toronto General Hospital, Toronto

M5G1X8

Princess Margaret Hospital, Toronto

H1T 2M4

Maisonneuve-Rosemont Hospital, Montreal

G1J 1Z4

Hopital Enfant-Jesus, Québec

G1S4L8

Hopital du Saint-Sacrement, Québec

EC1M 6BQ

Barts & London School of Medicine, London

OX3 0Du

John Radcliffe Hospital, Headington

BS2 8BJ

Bristol Royal Hospital for Children, Bristol

G4 OSF

Glasgow Royal Infirmary, Glasgow

LS1 3EX

Leeds General Infirmary, Leeds

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mesoblast, Inc.

INDUSTRY