- Joined
- Aug 14, 2010
- Messages
- 573
Osiris Protocol 603 is enrolling subjects with moderate-to-severe Crohn's disease who are intolerant to, or have previously failed therapy with, at least one steroid and at least one immunosuppressant and at least one biologic agent. The protocol investigates the safety and efficacy of using PROCHYMAL[tm] adult human stem cells to induce remission. PROCHYMAL is delivered through a vein in the arm four times over two weeks, for approximately an hour each time.
Study summary: A significant number of individuals with Crohn's disease do not find relief with existing steroidal, immunosuppressive, or biologic therapies, and are forced to seek surgery or other drastic measures for treatment. PROCHYMAL[tm] adult human stem cells are manufactured from healthy, volunteer donors, extensively tested, and are stored to be available as needed. Human and animal studies have shown that the cells do not require any donor-recipient matching. The cells may have both immunosuppressive and healing benefits in Crohn's disease. The cells naturally migrate specifically to sites of inflammation, so their effects are believed to be local and self-limiting rather than systemic. Osiris Protocol 603 is enrolling subjects to evaluate the ability of PROCHYMAL to induce remission in subjects with moderate-to-severe disease (Crohn's disease activity index -- CDAI -- of between 250 and 450, inclusive) who have failed or been intolerant of at least one drug in each of the steroid, immunosuppressant, and biologic classes.
http://www.clinicalconnection.com/exp/ExpandedPatientViewStudy763993.aspx
Evaluation of PROCHYMAL[tm] Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease
http://clinicaltrials.gov/show/NCT00482092
Clinical Pharmacology Study Group
Worcester, MA 01610
United States
Massachusetts General Hospital
Boston, MA 02114
United States
Brigham and Womens Hospital
Boston, MA 02115
United States
Dartmouth Hitchcock Medical Center
Lebanon, NH 03756
United States
University of Vermont
Burlington, VT 05401
United States
Gastroenterology Center of Connecticut
Hamden, CT 06518
United States
Holy Name Hospital
Teaneck, NJ 07666
United States
Gastroenterology Research Associates
Cedar Knolls, NJ 07927
United States
Weill Cornell Medical College
New York, NY 10028
United States
Mount Sinai School of Medicine
New York, NY 10029
United States
Rochester Institute for Digestive Diseases
Rochester, NY 14607
United States
Rochester General Hospital
Rochester, NY 14621
United States
Allegheney Center for Digestive Health
Pittsburgh, PA 15212
United States
University of Pittsburgh
Pittsburgh, PA 15213
United States
Chevy Chase Clinical Research
Chevy Chase, MD 20815
United States
National Institutes of Health
Bethesda, MD 20892
United States
.....
http://www.clinicalconnection.com/clinical_trials/condition/crohn's_disease.aspx
Study summary: A significant number of individuals with Crohn's disease do not find relief with existing steroidal, immunosuppressive, or biologic therapies, and are forced to seek surgery or other drastic measures for treatment. PROCHYMAL[tm] adult human stem cells are manufactured from healthy, volunteer donors, extensively tested, and are stored to be available as needed. Human and animal studies have shown that the cells do not require any donor-recipient matching. The cells may have both immunosuppressive and healing benefits in Crohn's disease. The cells naturally migrate specifically to sites of inflammation, so their effects are believed to be local and self-limiting rather than systemic. Osiris Protocol 603 is enrolling subjects to evaluate the ability of PROCHYMAL to induce remission in subjects with moderate-to-severe disease (Crohn's disease activity index -- CDAI -- of between 250 and 450, inclusive) who have failed or been intolerant of at least one drug in each of the steroid, immunosuppressant, and biologic classes.
http://www.clinicalconnection.com/exp/ExpandedPatientViewStudy763993.aspx
Evaluation of PROCHYMAL[tm] Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease
http://clinicaltrials.gov/show/NCT00482092
Clinical Pharmacology Study Group
Worcester, MA 01610
United States
Massachusetts General Hospital
Boston, MA 02114
United States
Brigham and Womens Hospital
Boston, MA 02115
United States
Dartmouth Hitchcock Medical Center
Lebanon, NH 03756
United States
University of Vermont
Burlington, VT 05401
United States
Gastroenterology Center of Connecticut
Hamden, CT 06518
United States
Holy Name Hospital
Teaneck, NJ 07666
United States
Gastroenterology Research Associates
Cedar Knolls, NJ 07927
United States
Weill Cornell Medical College
New York, NY 10028
United States
Mount Sinai School of Medicine
New York, NY 10029
United States
Rochester Institute for Digestive Diseases
Rochester, NY 14607
United States
Rochester General Hospital
Rochester, NY 14621
United States
Allegheney Center for Digestive Health
Pittsburgh, PA 15212
United States
University of Pittsburgh
Pittsburgh, PA 15213
United States
Chevy Chase Clinical Research
Chevy Chase, MD 20815
United States
National Institutes of Health
Bethesda, MD 20892
United States
.....
http://www.clinicalconnection.com/clinical_trials/condition/crohn's_disease.aspx
