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| Sponsor: | Osiris Therapeutics |
|---|---|
| Collaborator: |
Juvenile Diabetes Research Foundation |
| Information provided by: | Osiris Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00690066 |
Purpose
The purpose of this study is to establish the safety and efficacy of multiple administrations of PROCHYMAL® in subjects recently diagnosed with type 1 diabetes mellitus.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes Mellitus Type 1 Diabetes Diabetes Mellitus, Insulin-Dependent Juvenile Diabetes |
Drug: PROCHYMAL® Drug: Placebo |
Phase II |
| 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 II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of PROCHYMAL® (Ex Vivo Cultured Adult Human Mesenchymal Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM) |
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2008 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
PROCHYMAL®
|
Drug: PROCHYMAL®
Intravenous infusion of ex vivo cultured adult human mesenchymal stem cells
|
|
B: Placebo Comparator
Placebo
|
Drug: Placebo
Intravenous infusion of excipients of PROCHYMAL®
|
Diabetes mellitus refers to disorders in which the body has trouble controlling its blood glucose levels. There are two main types of diabetes: type 1 and type 2. Type 1 diabetes mellitus (T1DM), which is being studied in this trial, is an autoimmune disorder in which the body's own immune system attacks and destroys the cells that make insulin. These cells are called beta cells. As beta cells are destroyed, less insulin can be made. This causes blood sugar levels to increase above normal and can cause life-threatening hypo- and hyper-glycemic reactions. For this reason, people with type 1 diabetes must take insulin to help control their blood sugar levels. Over time, poorly controlled diabetes can lead to a variety of serious health conditions, including heart disease, stroke, blindness, amputations, kidney disease, and nerve damage. Insulin is the primary method of controlling diabetes by regulating blood glucose levels, but it may not reverse or prevent disease progression. The active ingredient in ROCHYMAL® is adult human mesenchymal stem cells (MSCs). MSCs have been shown to interact with the immune cells in the body, reducing inflammation and assisting in tissue repair. This study will help determine whether MSCs can protect normal pancreatic tissue from autoimmune attack and repair damaged pancreatic tissue, leading to an increase in insulin production and decrease in circulating blood glucose. The characteristics and biologic activity of PROCHYMAL®, along with a good safety profile in human trials to date, suggest that PROCHYMAL® may be a good candidate for addressing Type 1 Diabetes.
Eligibility| Ages Eligible for Study: | 12 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Dayna Buskirk | 352-335-9383 | diabetes@osiris.com |
| United States, Alabama | |
| University of Alabama, Division of Endocrinology & Metabolism | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Fernando Ovalle, M.D. | |
| Principal Investigator: Fernando Ovalle, M.D. | |
| United States, California | |
| Stanford University | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Kari Benassi, FNP 650-736-8948 karis@stanford.edu | |
| Principal Investigator: Darrell Wilson, M.D. | |
| Sub-Investigator: Bruce Buckingham, M.D. | |
| Scripps Whittier Diabetes Institute | Recruiting |
| LaJolla, California, United States, 92037 | |
| Principal Investigator: Athena Philis-Tsimikas, M.D. | |
| United States, Florida | |
| Diabetes Research Institute | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Jay Skyler, M.D. | |
| Principal Investigator: Jay Skyler, M.D. | |
| University of Florida | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Michael J. Haller, M.D. 352-392-2215 hallemj@peds.ufl.edu | |
| Principal Investigator: Michael J Haller, M.D. | |
| United States, Kentucky | |
| University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 40502 | |
| Principal Investigator: Dennis G Karounos, M.D. | |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Theresa Albright-Fischer, RN 612-626-2182 Albr0088@umn.edu | |
| Contact 800-688-5252 ext 62182 | |
| Principal Investigator: Antoinette Moran, M.D. | |
| United States, Nevada | |
| Nevada Alliance Against Diabetes | Recruiting |
| Las Vegas, Nevada, United States, 89101 | |
| Contact: Rubin Saavedra, M.D. | |
| Principal Investigator: Rubin Saavedra, M.D. | |
| Desert Endocrinology CRC | Recruiting |
| Henderson, Nevada, United States, 89052 | |
| Principal Investigator: William Litchfield, M.D. | |
| United States, North Carolina | |
| American Health Research, Inc. | Recruiting |
| Charlotte, North Carolina, United States, 28207 | |
| Contact: Claudia Moreno 704-926-8030 cmoreno@ahres.com | |
| Principal Investigator: Selwyn Spangenthal, M.D. | |
| University of North Carolina Diabetes Care Center | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Stefanie Jeremiah 919-484-0931 ext 269 | |
| Principal Investigator: John B Buse, M.D., Ph.D., FACE | |
| United States, Ohio | |
| Providence Health Partners - Center for Clinical Research | Recruiting |
| Dayton, Ohio, United States, 45439 | |
| Contact: Mary Corl, RN, BSN 937-297-8988 | |
| Principal Investigator: Lawrence G Ratcliff, M.D. | |
| The Lindner Clinical Trial Center | Recruiting |
| Cincinnati, Ohio, United States, 45219 | |
| Contact: Dean Kereiakes, M.D. | |
| Principal Investigator: Dean J Kereiakes, M.D. | |
| United States, Pennsylvania | |
| Cumberland Valley Endocrinology | Recruiting |
| Carlisle, Pennsylvania, United States, 17015 | |
| Principal Investigator: Andrew Behnke, M.D. | |
| United States, Tennessee | |
| AM Diabetes & Endocrinology Center | Recruiting |
| Bartlett, Tennessee, United States | |
| Contact: Kashif Latif, M.D. | |
| Principal Investigator: Kashif Latif, M.D. | |
| United States, Texas | |
| The University of Texas Southwestern Medical Center | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Philip Raskin, M.D. philip.raskin@utsouthwestern.edu | |
| Contact: Lourdes Pruneda 214-648-4717 maria.pruneda@utsouthwestern.edu | |
| Principal Investigator: Philip Raskin, M.D. | |
| United States, Utah | |
| Optimum Clinical Research, Inc. | Recruiting |
| Salt Lake City, Utah, United States, 84102 | |
| Contact: Jared Shields 801-363-7353 admin@ocresearch.com | |
| Principal Investigator: Jackson M Rhudy, M.D. | |
| United States, Virginia | |
| The Strelitz Diabetes Center, Eastern VA Medical School | Recruiting |
| Norfolk, Virginia, United States, 23510 | |
| Contact: Patricia Barlow, RN, BSN, CCRC 757-446-7258 barlowpm@evms.edu | |
| Principal Investigator: Aaron I Vinik, M.D., Ph.D. | |
| United States, Wisconsin | |
| University of Wisconsin Health- West Clinic | Recruiting |
| Madison, Wisconsin, United States, 53717 | |
| Principal Investigator: Melissa Meredith, M.D. | |
| Clinical and Transitional Science Institute | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Principal Investigator: Shailesh Patel, M.D. | |
More Information
| Responsible Party: | Osiris Therapeutics, Inc. ( Dayna Buskirk, Director, Clinical Development ) |
| Study ID Numbers: | 901 |
| Study First Received: | June 2, 2008 |
| Last Updated: | November 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00690066 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
T1DM Type 1 Diabetes Mellitus Type 1 Diabetes Diabetes Mellitus, Insulin-Dependent Juvenile Diabetes Adult Human Stem Cells |
Mesenchymal Stem Cells MSCs Insulin Osiris Prochymal |
|
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |