A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute Graft-Versus-Host Disease (aGVHD)

PHASE3CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

June 4, 2015

Primary Completion Date

April 9, 2018

Study Completion Date

April 9, 2018

Conditions
Grade B aGVHDGrade C aGVHDGrade D aGVHD
Interventions
DRUG

remestemcel-L

Participants were treated with IV remestemcel-L at a dose of 2 x 10\^6 MSC/kg (actual body weight at screening) twice per week for each of 4 consecutive weeks. Infusions were administered at least 3 days apart and no more than 5 days apart for any infusion.

Trial Locations (20)

10032

Columbia University Medical Center, New York

10174

Memorial Sloan Kettering Cancer Center, New York

10467

Albert Einstein College of Medicine, New York

19803

Alfred I. DuPont Hospital for Children of the Nemours Foundation, Wilmington

23284

Virginia Commonwealth University, Richmond

27705

Duke University Medical Center, Durham

29425

Medical University of South Carolina, Charleston

33136

Miami Children's Research Institute, Miami

39216

University of Mississippi Medical Center, Jackson

48201

Children's Hospital of Michigan, Detroit

53226

Medical College of Wisconsin, Milwaukee

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

63110

Washington University, St Louis

78229

Texas Transplant Institute, San Antonio

80045

Children's Hospital Colorado Center for Cancer/Blood Disorders, Aurora

90027

Children's Hospital Los Angeles, Los Angeles

92868

Children's Hospital of Orange County, Orange

94143

University of California at San Francisco, San Francisco

97239

Oregon University, Portland

98109

Fred Hutchinson Cancer Research, Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Quintiles, Inc.

INDUSTRY

lead

Mesoblast, Inc.

INDUSTRY