Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease
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|ClinicalTrials.gov Identifier: NCT00366145|
Recruitment Status : Completed
First Posted : August 21, 2006
Last Update Posted : October 13, 2011
|Condition or disease||Intervention/treatment||Phase|
|Graft Versus Host Disease||Biological: Mesenchymal Stem Cells Biological: placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
2 infusions a week for 4 weeks
Other Name: excipients without adult human mesenchymal stem cells
- Complete Response of greater than or equal to 28 days duration [ Time Frame: Day 100 ]
- Survival at 180 days post first infusion [ Time Frame: 180 Days ]
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 ClinicalTrials.gov identifier (NCT number): NCT00366145
|Principal Investigator:||Paul Martin, MD||Fred Hutchinson Cancer Center|