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

PHASE2CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

April 27, 2005

Primary Completion Date

July 28, 2006

Study Completion Date

July 14, 2008

Conditions
Graft Vs Host Disease
Interventions
DRUG

Prochymal® - 2 Million cells/kg

2 million hMSCs/kg actual body weight, IV on study Days 1 and 4

DRUG

Prochymal®- 8 Million cells/kg

8 million hMSCs/kg actual body weight IV on study Days 1 and 4

DRUG

Methylprednisolone

Methylprednisolone 2 mg/kg administered intravenously.

DRUG

Prednisone

Prednisone 2.5 mg/kg administered orally.

DRUG

Cyclosporine

Administered as prescribed by the caregiver.

DRUG

Tacrolimus

Administered as prescribed by the caregiver.

DRUG

Mycophenolate Mofetil

Administered as prescribed by the caregiver.

Trial Locations (9)

10029

Mt. Sinai Hospital, New York

10595

New York Medical College, Valhalla

14263

Roswell Park Cancer Institute, Buffalo

14642

University of Rochester, Rochester

46237

St. Francis Hospital, Indianapolis

53226

Medical College of Wisconsin, FEC, Milwaukee

64111

Kansas City Cancer Centers - BMT, Kansas City

77030

MD Anderson Cancer Center, Houston

07601

The Cancer Center at Hackensack University, Hackensack

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mesoblast, Inc.

INDUSTRY