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This study is being conducted to assess the overall safety and tolerability of a single intravenous infusion of three doses of Mesenchymal Precursor Cells versus Placebo in subjects with Type 2 Diabetes inadequately controlled on Metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | MPC dose 1 or Placebo |
|
| Cohort 2 | Experimental | MPC dose 2 or Placebo |
|
| Cohort 3 | Experimental | MPC dose 3 or Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal Precursor Cells (MPCs) | Drug | Single intravenous infusion of MPCs Dose 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary objective of the study is to assess the safety and tolerability of MPC therapy | Outcomes include the measurement of the following safety parameters:
| 116 Weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| K Segal, PhD | Mesoblast, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SC Clinical Research | Garden Grove | California | 92844 | United States | ||
| Diabetes Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26153271 | Derived | Skyler JS, Fonseca VA, Segal KR, Rosenstock J; MSB-DM003 Investigators. Allogeneic Mesenchymal Precursor Cells in Type 2 Diabetes: A Randomized, Placebo-Controlled, Dose-Escalation Safety and Tolerability Pilot Study. Diabetes Care. 2015 Sep;38(9):1742-9. doi: 10.2337/dc14-2830. Epub 2015 Jul 7. |
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| Mesenchymal Precursor Cells (MPCs) |
| Drug |
Single intravenous infusion of MPCs Dose 2 |
|
| Mesenchymal Precursor Cells (MPCs) | Drug | Single intravenous infusion of MPCs Dose 3 |
|
| Miami |
| Florida |
| 33136 |
| United States |
| Compass Research | Orlando | Florida | 32806 | United States |
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| Tulane University Medical Center | New Orleans | Louisiana | 70112 | United States |
| Big Sky Clinical Research | Butte | Montana | 59701 | United States |
| Desert Endocrinology Clinical Research Center-Henderson | Henderson | Nevada | 89052 | United States |
| Alliance Against Diabetes/AAD Clinical Research | Las Vegas | Nevada | 89101 | United States |
| Active Practices and Research | Newington | New Hampshire | 03801 | United States |
| The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Providence Health Partners - Center for Clinical Reseach | Dayton | Ohio | 45439 | United States |
| Dallas Diabetes and Endocrine Center | Dallas | Texas | 75230 | United States |
| West Houston Clinical Research Services | Houston | Texas | 77055 | United States |
| Paragon Research Center | San Antonio | Texas | 78205 | United States |
| Wasatch Clinical Research | Salt Lake City | Utah | 84107 | United States |
| National Clinical Research - Norfolk, Inc | Norfolk | Virginia | 23502 | United States |
| National Clinical Research - Richmond, Inc. | Richmond | Virginia | 23294 | United States |
| Capital Clinical Research Center | Olympia | Washington | 98502 | United States |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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