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Trial record 12 of 24 for:    Prochymal

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00366145
Recruitment Status : Completed
First Posted : August 21, 2006
Last Update Posted : October 13, 2011
Information provided by (Responsible Party):
Osiris Therapeutics

Brief Summary:
The purpose of this study is to evaluate the efficacy and gather additional safety of Prochymal in subjects who have failed to respond to steroid treatment of Grades B-D acute GVHD.

Condition or disease Intervention/treatment Phase
Graft Versus Host Disease Biological: Mesenchymal Stem Cells Biological: placebo Phase 3

Detailed Description:

Approximately 6300 patients receive allogeneic hematopoietic stem cell transplants in the United States each year (IBMTR, 2003). Nearly 50% (approximately 3,150) of these patients develop acute GVHD (Goker et al). A fraction of these patients (approximately 870) will progress to the severe stages of the disease, Grades III-IV. It is estimated that nearly 82% of those patients with severe acute GVHD will be steroid refractory (Przepiorka et al., 1995) and of these, only 50% of steroid-refractory patients wll respond to secondary and tertiary treatments (Greinix et al., 2000). Thus, roughly 350 patients each year face tremendous odds against survival. In addition, most patients who initially responded to secondary and tertiary treatments have a high risk of dying within the first year (Remberger et al., 2001; Anasetti et al., 1994). Development of new therapeutic agents and strategies to rescue patients with steroid refractory, acute GVHD would provide a significant benefit in an area of unmet medical need.

Patients will receive standard of care in addition to adult mesenchymal stem cells or placebo.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Prochymal(Ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Steroid Refractory Acute GVHD
Study Start Date : July 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
Active Comparator: 1
Patients who receive standard of care plus treatment with ex vivo cultured adult human Mesenchymal Stem Cells
Biological: Mesenchymal Stem Cells
2 million cells/kg twice a week for 4 weeks
Other Name: Prochymal

Placebo Comparator: 2
Patients who receive standard of care and do not receive treatment with ex vivo cultured adult human mesenchymal stem cells.
Biological: placebo
2 infusions a week for 4 weeks
Other Name: excipients without adult human mesenchymal stem cells

Primary Outcome Measures :
  1. Complete Response of greater than or equal to 28 days duration [ Time Frame: Day 100 ]

Secondary Outcome Measures :
  1. Survival at 180 days post first infusion [ Time Frame: 180 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects must be 6 months to 70 years of age, inclusive
  • Subjects who have failed to respond to steroid treatment: Failure to respond to steroid treatment is defined as any grade B-D (IBMTR grading) of acute GVHD that shows: No improvement after 3 days and a duration of no greater than 2 weeks while receiving treatment with Methylprednisolone (greater than or equal to 1 mg/kg/day) or equivalent.
  • Subjects must be treated within 4 days of randomization . In urgent situations 2nd line therapy may be started 24 hours prior to randomization , and Prochymal must be initiated within the following 3 days.
  • Subjects who have received an increase in their steroid dose treatment prior to randomization will be eligible for enrollment. An increase in steroid dose will not be considered as second line therapy.
  • Subjects must have adequate renal function as defined by: Calculated Creatinine Clearance of >30mL/min using the Cockroft Gault equation
  • For pediatric patients: Schwartz equation: (Patient population: infants over 1 week old through adolescence (<18 years old)
  • Subjects who are women of childbearing potential, must be non-pregnant, not breast-feeding, and use adequate contraception. Male subjects must use adequate contraception
  • Subject must have a minimum Karnofsky Performance Level of at least 30 at the time of study entry
  • Subject (or legal representative where appropriate) must be capable of providing written informed consent.

Exclusion Criteria:

  • Subject has started treatment with second line therapy >24 hours prior to randomization.
  • Subject has received agents other than steroids for primary treatment of acute GVHD
  • Subject is participating in the CTN Protocol 0302
  • Subject has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the subject including uncontrolled infection, heart failure, pulmonary hypertension, etc.
  • Subjects may not receive any other investigational agents (not approved by the FDA) concurrently during study participation or within 30 days of randomization.
  • Subject has a known allergy to bovine or porcine products.
  • Subject has received a transplant for a solid tumor disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00366145

  Hide Study Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
City of Hope
Duarte, California, United States, 91010
Univeristy of California San Francisco
San Francisco, California, United States, 94143
United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
United States, Florida
University of Miami
Miami, Florida, United States, 33136
All Children's Hospital
St. Petersburg, Florida, United States, 33701
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Northside Hospital
Atlanta, Georgia, United States, 30342
United States, Illinois
Northwestern Center for Clinical Research
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Illinois - Chicago
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana Blood and Bone Marrow Transplant Center
Beech Grove, Indiana, United States, 46107
United States, Iowa
Univeristy of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Louisiana State University
Shreveport, Louisiana, United States, 71130
United States, Maryland
University of Maryland/Greenbaum
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Tufts-New England Medical Center
Boston, Massachusetts, United States, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos/Wayne State University
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, Mississippi
Univeristy of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States, 68198
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park
Buffalo, New York, United States, 14263
New York Presbyterian Hospital
New York, New York, United States, 10021
Mount Sinai Medical Center
New York, New York, United States, 10029
Columbia University/New York Presbyterian Hospital
New York, New York, United States, 10032
University of Rochester
Rochester, New York, United States, 14642
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Wake Forest Univeristy School of Medicine
Winston Salem, North Carolina, United States, 27157
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Texas Cancer Center at Medical City
Dallas, Texas, United States, 75230
Baylor University
Dallas, Texas, United States, 75246
Univeristy of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Texas Research Center
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Commonwealth/Massey Cancer Center
Richmond, Virginia, United States, 23298
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
United States, Wisconsin
University of Wisconsin Madison
Madison, Wisconsin, United States, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, Queensland
Royal Brisbane Hospital
Herston, Queensland, Australia, 4029
Australia, Victoria
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6100
Canada, Alberta
Co-Medica Research Network
Calgary, Alberta, Canada, T1Y6J4
Canada, British Columbia
British Columbia's Children's Hospital
Vancouver, British Columbia, Canada, V6H3V4
Canada, Manitoba
Cancer Care Manitoba
Winnipeg, Manitoba, Canada, R3E0V9
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H2Y9
Canada, Ontario
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada, L8N3Z5
London Health Sciences Centre- Westminster Campus
London, Ontario, Canada, N6A4G5
Ottawa Hospital
Ottawa, Ontario, Canada, K1H8L6
Toronto General Hospital
Toronto, Ontario, Canada, M5G 1X8
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G1X8
Canada, Quebec
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Hopital Enfant-Jesus
Quebec, Canada, G1J 1Z4
Hopital du Saint-Sacrement
Quebec, Canada, G1S4L8
Universia degli Studi di Pesaro
Pesaro, PU, Italy, 61100
IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Kantonsspital Basel
Basel, Switzerland, 4031
United Kingdom
Barts & London School of Medicine
London, England, United Kingdom, EC1M 6BQ
John Radcliffe Hospital
Headington, Oxford, United Kingdom, OX3 0Du
Bristol Royal Hospital for Children
Bristol, UK, United Kingdom, BS2 8BJ
Glasgow Royal Infirmary
Glasgow, UK, United Kingdom, G4 OSF
Leeds General Infirmary
Leeds, UK, United Kingdom, LS1 3EX
Sponsors and Collaborators
Osiris Therapeutics
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Principal Investigator: Paul Martin, MD Fred Hutchinson Cancer Center

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Osiris Therapeutics Identifier: NCT00366145     History of Changes
Obsolete Identifiers: NCT00476840
Other Study ID Numbers: 280
First Posted: August 21, 2006    Key Record Dates
Last Update Posted: October 13, 2011
Last Verified: October 2011
Keywords provided by Osiris Therapeutics:
acute GVHD
steroid refractory GVHD
severe steroid refractory acute GVHD
steroid refractory
Steroid Refractory Acute Graft Versus Host Disease
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases