Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Osiris Therapeutics |
---|---|
Information provided by: | Osiris Therapeutics |
ClinicalTrials.gov Identifier: | NCT00366145 |
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 | Intervention | Phase |
---|---|---|
Graft Versus Host Disease |
Biological: Mesenchymal Stem Cells Biological: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD |
Estimated Enrollment: | 240 |
Study Start Date: | July 2006 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Mesenchymal Stem Cells
|
Biological: Mesenchymal Stem Cells
2 million cells/kg twice a week for 4 weeks
|
2: Placebo Comparator
Placebo
|
Biological: placebo
2 infusions a week for 4 weeks
|
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.
Ages Eligible for Study: | 6 Months to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Paul Martin, MD | Fred Hutchinson Cancer Center |
Responsible Party: | Osiris Therapeutics, Inc. ( Moya Daniels ) |
Study ID Numbers: | 280 |
Study First Received: | August 17, 2006 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00366145 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Italy: Ministry of Health; Spain: Ministry of Health; United Kingdom: Medicines & Healthcare Products Regulatory Agency; Australia: Therapeutic Goods Administration |
acute GVHD steroid refractory GVHD severe steroid refractory acute GVHD steroid refractory Steroid Refractory Acute Graft Versus Host Disease |
Graft versus host disease Graft vs Host Disease Homologous wasting disease |
Immune System Diseases |